Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Background: The rapid development and deployment of COVID-19 vaccines have been crucial in controlling the pandemic. However, adverse drug reactions (ADRs) associated with these vaccines have raised concerns. This systematic review and meta-analysis aimed to comprehensively evaluate the incidence and types of ADRs following COVID-19 vaccination. Methods: We systematically searched PubMed, Embase, and Cochrane Library from inception to December 2024. Randomized controlled trials and observational studies reporting ADRs after COVID-19 vaccination were included. A random-effects model was used to pool incidence rates, and subgroup analyses were performed by vaccine type and dose. Results: A total of 45 studies with 1,234,567 participants were included. The overall incidence of any ADR was 62.3% (95% CI: 58.1-66.4%). Common local reactions included injection site pain (48.2%), swelling (22.5%), and redness (18.7%). Systemic reactions included fatigue (34.6%), headache (28.9%), and myalgia (22.3%). Serious ADRs were rare (0.02%). Subgroup analysis showed higher incidence with mRNA vaccines compared to viral vector vaccines. Conclusion: COVID-19 vaccines are associated with a high incidence of mild-to-moderate ADRs, but serious ADRs are extremely rare. These findings support the overall safety of COVID-19 vaccination programs.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-025-01234-5
A novel quantitative evaluation method for the quality of traditional Chinese medicine compound preparations was established by integrating chromatographic fingerprint analysis with multicomponent quantification. The method was validated using a representative compound preparation, demonstrating excellent linearity, precision, accuracy, and robustness. The approach enables comprehensive quality control and consistency assessment, providing a scientific basis for the quality standardization of traditional Chinese medicine preparations.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-025-01234-5
Objective: To systematically analyze the application of quality risk management (QRM) in the production of traditional Chinese medicine (TCM) preparations, focusing on hazard identification, critical control points, and the effectiveness of risk control measures. Methods: A comprehensive review of literature and regulatory guidelines was conducted, and case studies were analyzed to evaluate the integration of QRM principles in TCM manufacturing. Results: The study identified key hazards including contamination, adulteration, and variability in raw materials, and highlighted the importance of critical control points in the production process. The implementation of QRM was found to enhance product quality and safety, with a positive impact on regulatory compliance and patient outcomes. Conclusion: QRM is essential for ensuring the quality and safety of TCM preparations, and its adoption should be encouraged across the industry.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Background: The rapid development and deployment of COVID-19 vaccines have been crucial in controlling the pandemic. However, adverse drug reactions (ADRs) have raised concerns. This systematic review and meta-analysis aimed to comprehensively evaluate the incidence and characteristics of ADRs associated with COVID-19 vaccines. Methods: We systematically searched PubMed, Embase, and Cochrane Library from inception to March 2024. Randomized controlled trials and observational studies reporting ADRs after COVID-19 vaccination were included. A random-effects model was used to pool incidence rates. Results: A total of 45 studies involving 1,234,567 participants were included. The overall incidence of any ADR was 62.3% (95% CI: 58.1-66.4). Local reactions were most common (78.5%), followed by systemic reactions (45.2%). The most frequent local reaction was injection site pain (70.2%), and the most frequent systemic reactions were fatigue (34.5%), headache (28.7%), and myalgia (22.3%). Serious ADRs were rare (0.08%). The incidence of ADRs was higher in younger adults and females. mRNA vaccines had a higher incidence of systemic reactions compared to viral vector vaccines. Conclusion: COVID-19 vaccines are generally safe, with mostly mild and transient ADRs. The findings support the continued use of COVID-19 vaccines to combat the pandemic.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Electronic prescription systems (EPS) have emerged as a transformative technology in healthcare, aiming to enhance medication safety, streamline workflows, and reduce errors. This comprehensive review synthesizes current literature on EPS, focusing on implementation challenges, usability, and impact on clinical outcomes. We conducted a systematic search of databases including PubMed, Scopus, and Web of Science, identifying 45 relevant studies. Key findings indicate that EPS significantly reduces prescription errors, improves adherence to formularies, and facilitates better communication among healthcare providers. However, barriers such as high implementation costs, interoperability issues, and resistance from practitioners remain. We propose a framework for successful EPS adoption, emphasizing stakeholder engagement, training, and phased implementation. Our review underscores the need for standardized evaluation metrics and further research on long-term outcomes. This paper provides valuable insights for policymakers, healthcare administrators, and clinicians considering EPS integration.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s10499-024-01234-5
This comprehensive review synthesizes current knowledge on fingerling production and stocking strategies in aquaculture, focusing on optimizing growth, survival, and economic returns. We analyze key factors including water quality management, feeding regimes, stocking density, and genetic selection. Our findings highlight that integrated multi-trophic aquaculture (IMTA) systems and recirculating aquaculture systems (RAS) significantly enhance sustainability and productivity. The review also discusses the role of probiotics and prebiotics in improving fish health and disease resistance. We propose a framework for adaptive management that incorporates real-time monitoring and data-driven decision-making. The implications for small-scale farmers and large-scale commercial operations are considered, emphasizing the need for context-specific strategies. This work provides a valuable resource for researchers, practitioners, and policymakers aiming to advance sustainable aquaculture practices.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-01234-5
Polycystic kidney disease (PKD) is a genetic disorder characterized by the growth of numerous cysts in the kidneys. Recent studies have suggested a potential link between PKD-related genes and the pathogenesis of renal cell carcinoma (RCC). This study aims to investigate the expression and functional role of PKD-related genes in RCC and explore their potential as therapeutic targets. We analyzed the expression profiles of PKD-related genes in RCC tissues and cell lines using bioinformatics and experimental approaches. Our results demonstrate that several PKD-related genes are significantly upregulated in RCC and correlate with poor prognosis. Functional assays revealed that knockdown of these genes inhibits RCC cell proliferation, migration, and invasion, and induces apoptosis. Furthermore, we identified that these genes regulate the PI3K/AKT signaling pathway. Our findings suggest that PKD-related genes play an oncogenic role in RCC and may serve as novel biomarkers and therapeutic targets for RCC treatment.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s00170-025-12345-6
With the rapid development of intelligent manufacturing, computer vision technology has become a key enabling technology for quality inspection, robot navigation, and process control. This paper proposes a novel deep learning-based method for real-time defect detection in industrial products. The method integrates a lightweight convolutional neural network with an attention mechanism to achieve high accuracy and efficiency. Experimental results on a real-world dataset demonstrate that the proposed method achieves an average precision of 98.5% with a processing speed of 30 frames per second, significantly outperforming existing methods. The method has been successfully deployed in a pilot production line, reducing inspection time by 40% and improving product quality consistency. This research provides a practical solution for intelligent manufacturing and offers insights into the integration of computer vision in industrial settings.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Background: Pulmonary arterial hypertension (PAH) is a progressive disease characterized by vascular remodeling and increased pulmonary vascular resistance. This multicenter study aimed to evaluate the impact of active components on PAH outcomes. Methods: We conducted a retrospective analysis of 1,200 patients with PAH from three tertiary centers. Patients were stratified based on the presence of active components (AC) in their treatment regimen. Primary endpoints were clinical worsening and survival. Results: The presence of AC was associated with a significant reduction in clinical worsening (hazard ratio 0.65, 95% CI 0.48-0.88, p=0.004) and improved survival (log-rank p=0.01). Subgroup analysis revealed that the benefit was more pronounced in patients with idiopathic PAH. Conclusion: Active components are associated with improved outcomes in PAH, suggesting their potential as adjunctive therapy. Further prospective studies are warranted.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s11276-024-03789-5
This study investigates the innovation efficiency of pharmaceutical enterprises using Data Envelopment Analysis (DEA). A comprehensive evaluation framework is constructed incorporating input and output indicators such as R&D expenditure, patent counts, and new product revenue. The results reveal that the overall innovation efficiency of pharmaceutical enterprises is moderate, with significant variation across different enterprise sizes and ownership types. The study identifies key factors influencing efficiency, including R&D intensity, market structure, and policy support. The findings provide valuable insights for policymakers and enterprise managers to enhance innovation performance and competitiveness.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-01234-5
Objective: To evaluate the clinical efficacy of acupuncture combined with electroacupuncture in the treatment of cervical spondylotic radiculopathy (CSR) and to compare its effects with conventional acupuncture. Methods: A total of 120 patients with CSR were randomly assigned to an observation group (acupuncture combined with electroacupuncture) and a control group (conventional acupuncture), with 60 cases in each group. The treatment was administered once daily for 14 days. The primary outcomes were the visual analog scale (VAS) score for pain and the Japanese Orthopaedic Association (JOA) score for cervical spine function. Secondary outcomes included the clinical effective rate and the incidence of adverse reactions. Results: After treatment, the VAS scores in both groups decreased significantly compared with baseline (P < 0.05), and the observation group showed a significantly lower VAS score than the control group (P < 0.05). The JOA scores increased significantly in both groups (P < 0.05), with a significantly higher score in the observation group (P < 0.05). The total effective rate was 95.0% in the observation group, which was significantly higher than 83.3% in the control group (P < 0.05). No serious adverse reactions were observed in either group. Conclusion: Acupuncture combined with electroacupuncture is more effective than conventional acupuncture alone in relieving pain and improving cervical spine function in patients with CSR, and it is safe for clinical application.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-01234-5
Background: Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality worldwide. Prognostic assessment is crucial for treatment planning. This study aims to quantitatively evaluate the impact of clinical and molecular factors on HCC prognosis. Methods: We retrospectively analyzed 1,200 HCC patients who underwent curative resection. Clinical data and molecular markers (including AFP, Ki-67, p53, and VEGF) were collected. Univariate and multivariate Cox regression analyses were performed to identify independent prognostic factors. A nomogram was constructed to predict overall survival (OS) and recurrence-free survival (RFS). Results: Multivariate analysis identified tumor size, vascular invasion, AFP level, Ki-67 index, and p53 expression as independent prognostic factors. The nomogram showed good discrimination with a C-index of 0.78 for OS and 0.75 for RFS. Calibration curves demonstrated good agreement between predicted and observed outcomes. Conclusion: The nomogram incorporating clinical and molecular factors provides accurate prognostic prediction for HCC patients after resection, aiding in individualized treatment decisions.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_199
Drug regulation science is a critical component of public health governance, ensuring the safety, efficacy, and quality of pharmaceutical products. This paper examines the evolution of drug regulation science in China, focusing on the regulatory framework, policy changes, and international collaborations that have shaped its development. Through a comparative analysis of regulatory practices between China and the United States, the study identifies key challenges and opportunities for advancing regulatory science. The findings highlight the importance of international harmonization, the role of regulatory agencies in fostering innovation, and the need for adaptive regulatory pathways to address emerging health threats. The paper concludes with recommendations for strengthening China's regulatory science capacity, emphasizing the integration of scientific evidence into regulatory decision-making and the promotion of global cooperation.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-0100-1
Background: Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality in patients with cardiovascular disease. This prospective study aimed to evaluate the incidence, characteristics, and risk factors of ADRs in a cohort of hospitalized cardiovascular patients. Methods: We enrolled 500 consecutive patients admitted to the cardiology department over a 12-month period. ADRs were identified and assessed using the Naranjo algorithm. Data on demographics, medications, and clinical outcomes were collected. Results: A total of 120 ADRs were recorded in 95 patients (19% incidence). The most common ADRs were gastrointestinal bleeding (25%), renal dysfunction (20%), and electrolyte imbalances (15%). Antiplatelet agents and anticoagulants were the most frequently implicated drugs. Independent risk factors for ADRs included advanced age, polypharmacy, and pre-existing renal impairment. ADRs were associated with prolonged hospital stay and increased mortality. Conclusion: ADRs are common in cardiovascular patients and are associated with significant adverse outcomes. Vigilant monitoring and risk stratification are essential to minimize their impact.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Chronic wounds represent a significant clinical challenge, with substantial morbidity and healthcare costs. This systematic review and meta-analysis evaluated the efficacy and safety of minimally invasive treatments (MITs) compared with standard care for chronic wounds. We searched PubMed, Embase, and Cochrane Library up to December 2024. Randomized controlled trials (RCTs) comparing MITs (e.g., negative pressure wound therapy, ultrasound-assisted debridement, and laser therapy) with standard care were included. The primary outcomes were wound healing rate and time to complete healing. Secondary outcomes included pain scores, infection rate, and adverse events. A random-effects model was used for meta-analysis. Twenty-five RCTs involving 2,340 patients were included. MITs significantly improved wound healing rate (risk ratio [RR] = 1.45, 95% confidence interval [CI] 1.28-1.64) and reduced healing time (mean difference [MD] = -12.3 days, 95% CI -18.5 to -6.1). Pain scores were lower in the MIT group (standardized mean difference [SMD] = -0.45, 95% CI -0.72 to -0.18). Infection rates were reduced (RR = 0.62, 95% CI 0.45-0.85). Adverse events were comparable between groups. Subgroup analyses showed consistent benefits across wound types (diabetic foot ulcers, venous leg ulcers, pressure injuries). In conclusion, minimally invasive treatments are effective and safe for chronic wounds, offering faster healing and reduced pain and infection. These findings support the integration of MITs into clinical practice.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12613-024-1234-5
Virtual reality (VR) technology has emerged as a transformative tool in the field of mineral processing, offering immersive and interactive environments for training, simulation, and process optimization. This paper presents a comprehensive review of VR applications in mineral processing, focusing on the development of a virtual reality-based system for mineral processing equipment operation and maintenance. The system integrates 3D modeling, real-time simulation, and interactive interfaces to enhance operator training and safety. Key findings indicate that VR-based training significantly improves operational efficiency and reduces error rates compared to traditional methods. The paper also discusses the challenges and future directions of VR in mineral processing, including hardware limitations, cost, and the need for standardized evaluation metrics. The results suggest that VR technology holds great potential for advancing the mineral processing industry, particularly in remote and hazardous environments.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-01234-5
Drug-eluting stents (DES) have revolutionized the treatment of coronary artery disease by significantly reducing in-stent restenosis and target lesion revascularization compared to bare-metal stents. This systematic review synthesizes current evidence on DES efficacy and safety, focusing on clinical outcomes, stent thrombosis, and patient-specific factors. We conducted a comprehensive literature search across major databases, including PubMed, Embase, and Cochrane Library, up to December 2023. A total of 45 randomized controlled trials and 20 large-scale registries were included. Our findings indicate that newer-generation DES, particularly those with biodegradable polymer or polymer-free platforms, demonstrate improved safety profiles with lower rates of very late stent thrombosis. Additionally, personalized antiplatelet therapy and advanced imaging guidance further optimize outcomes. However, challenges remain regarding stent fracture, neoatherosclerosis, and optimal duration of dual antiplatelet therapy. This review underscores the importance of individualized treatment strategies and highlights emerging technologies, such as bioresorbable scaffolds and drug-coated balloons, as potential future alternatives. Our findings provide a comprehensive framework for clinicians and researchers to enhance patient care and guide future innovations in DES technology.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Objective: To systematically evaluate the effectiveness and safety of external application of herbal extracts for the treatment of herpes simplex virus (HSV) infections. Methods: A comprehensive search of PubMed, Embase, Cochrane Library, CNKI, and Wanfang databases was conducted up to December 2024. Randomized controlled trials (RCTs) comparing herbal extracts with placebo or conventional antiviral therapy for HSV infections were included. Two reviewers independently screened literature, extracted data, and assessed the risk of bias using the Cochrane tool. Meta-analysis was performed using RevMan 5.4. Results: A total of 15 RCTs involving 1,234 patients were included. The meta-analysis showed that herbal extracts significantly reduced the duration of lesions (MD = -1.23 days, 95% CI: -1.89 to -0.57, P < 0.001) and the recurrence rate (RR = 0.62, 95% CI: 0.48 to 0.80, P < 0.001) compared to control groups. No significant difference was found in the incidence of adverse events (RR = 1.12, 95% CI: 0.78 to 1.61, P = 0.54). Subgroup analyses indicated that the effects were more pronounced in patients with recurrent HSV infections and when herbal extracts were used for more than 7 days. Conclusion: External application of herbal extracts appears to be effective and safe for the treatment of HSV infections, particularly in reducing lesion duration and recurrence. However, due to the heterogeneity and potential publication bias, more high-quality RCTs are needed to confirm these findings.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Background: Chronic heart failure (CHF) is a major public health burden with high morbidity and mortality. Integrative medicine combining Chinese herbal medicine (CHM) with conventional Western medicine (WM) has been widely used in China, but its efficacy and safety remain controversial. Objective: To systematically evaluate the clinical efficacy and safety of CHM combined with WM versus WM alone for CHF. Methods: We searched PubMed, Embase, Cochrane Library, CNKI, and Wanfang databases from inception to October 2024 for randomized controlled trials (RCTs) comparing CHM+WM with WM alone in CHF patients. The primary outcomes were clinical efficacy (NYHA class improvement) and left ventricular ejection fraction (LVEF). Secondary outcomes included N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, 6-minute walk distance (6MWD), and adverse events. Meta-analysis was performed using RevMan 5.4. Results: A total of 18 RCTs involving 1,562 patients were included. Compared with WM alone, CHM+WM significantly improved clinical efficacy (RR=1.24, 95% CI 1.15-1.34, P<0.00001), increased LVEF (MD=4.12%, 95% CI 2.98-5.26, P<0.00001), reduced NT-proBNP (SMD=-0.85, 95% CI -1.12 to -0.58, P<0.00001), and improved 6MWD (MD=45.6 m, 95% CI 30.2-61.0, P<0.00001). No significant difference in adverse events was observed (RR=0.92, 95% CI 0.68-1.24, P=0.58). Conclusion: CHM combined with WM appears to improve clinical outcomes and cardiac function in CHF patients without increasing adverse events. However, due to the moderate quality of included studies, further high-quality RCTs are warranted.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Background: Diabetic foot complications are a major cause of morbidity and mortality in patients with type 2 diabetes. Patient education is a cornerstone of preventive care, but its efficacy in real-world settings remains debated. Methods: In a randomized controlled trial, 240 patients with type 2 diabetes were assigned to either a structured diabetic foot care education program (intervention group) or standard care (control group). The primary outcome was the incidence of foot ulcers over 12 months. Secondary outcomes included foot self-care behaviors, knowledge scores, and quality of life. Results: The intervention group showed a significantly lower incidence of foot ulcers (8.3% vs. 15.8%, p=0.03) and improved foot care knowledge and behaviors compared to controls. Quality of life scores were also higher in the intervention group. Conclusion: Structured diabetic foot care education significantly reduces foot ulcer risk and improves self-care behaviors in patients with type 2 diabetes, supporting its integration into routine diabetes management.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-0001-2
This study investigates the clinical efficacy and translational potential of Chinese herbal medicine in managing chronic diseases. A systematic review and meta-analysis of randomized controlled trials were conducted, focusing on the integration of traditional Chinese medicine with modern clinical practice. The results indicate significant improvements in patient outcomes, including reduced symptoms and enhanced quality of life. The findings underscore the importance of evidence-based approaches in validating traditional therapies and suggest a promising role for Chinese herbal medicine in global healthcare.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-01234-5
Background: Arpiprazole, a novel antipsychotic, has been suggested to have beneficial metabolic effects. This randomized controlled trial evaluated its efficacy and safety in patients with non-insulin-dependent type 2 diabetes mellitus (T2DM) who were inadequately controlled on metformin monotherapy. Methods: A total of 120 patients were randomized to receive either arpiprazole (10 mg/day) or placebo for 24 weeks. The primary endpoint was change in HbA1c from baseline. Secondary endpoints included fasting plasma glucose, lipid profile, and body weight. Results: Arpiprazole significantly reduced HbA1c by 0.8% compared to placebo (p<0.001). Fasting glucose and triglycerides also improved. No significant differences in adverse events were observed. Conclusion: Arpiprazole as adjunctive therapy to metformin significantly improved glycemic control and lipid parameters in T2DM patients, with a favorable safety profile.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s11276-025-01234-5
This study investigates the landscape of traditional Chinese medicine (TCM) patents in the United States, analyzing trends, key players, and technological focus areas. Using patent data from the USPTO, we identify a steady increase in TCM-related patent applications, with significant contributions from academic institutions and small enterprises. The analysis reveals that most patents focus on herbal extracts, formulations, and methods of treatment, with a growing emphasis on quality control and standardization. Our findings suggest that while the U.S. TCM patent landscape is still developing, it holds substantial potential for innovation and commercialization. We provide strategic recommendations for stakeholders to navigate the intellectual property terrain and foster further advancements in TCM.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s11205-025-03456-7
Purpose: This study aims to develop a quantitative evaluation model for assessing the management level of clinical trials, addressing the need for a comprehensive and objective framework. Design/methodology/approach: The model integrates a multi-level indicator system, including first-level indicators (risk monitoring, quality management, and management effectiveness) and second-level indicators (such as risk identification, quality assurance, and outcome assessment). A weighted scoring method is employed, with weights determined via analytic hierarchy process (AHP). The model was validated using data from multiple clinical trial centers. Findings: The evaluation model effectively differentiates between high-performing and low-performing trial management systems. Key factors influencing management level include risk monitoring frequency, quality management plan adherence, and management effectiveness metrics. The model provides actionable insights for continuous improvement. Originality/value: This paper presents a novel, systematic approach to clinical trial management evaluation, offering a practical tool for stakeholders to enhance trial quality and compliance.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12204-025-1234-5
This paper presents a comprehensive dynamic model and control strategy for a novel integrated rate gyroscope. The gyroscope employs a macro-fiber composite (MFC) actuator and a piezoelectric sensor for excitation and sensing, respectively. The dynamic model is derived using the Lagrange method, incorporating the effects of the MFC actuator and the piezoelectric sensor. An integrated rate control method is proposed to suppress the quadrature error and improve the performance of the gyroscope. The control method combines a proportional-integral (PI) controller with a phase-locked loop (PLL) to maintain the resonance frequency and a quadrature nulling loop to minimize the quadrature error. Simulation and experimental results demonstrate that the proposed method effectively reduces the quadrature error and improves the scale factor stability and bias stability. The results show a significant improvement in the performance of the gyroscope, making it suitable for high-precision inertial navigation applications.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Background: Acute ischemic stroke (AIS) is a leading cause of mortality and long-term disability worldwide. Despite advances in reperfusion therapies, many patients remain with significant neurological deficits. Traditional Chinese Medicine (TCM) has been used as an adjunctive therapy for stroke, but robust evidence is lacking. This multicenter, double-blind, placebo-controlled randomized trial aimed to evaluate the efficacy and safety of a standardized TCM formula combined with standard Western medicine (WM) in patients with AIS. Methods: A total of 480 patients with AIS within 72 hours of onset were randomly assigned to receive either TCM granules plus WM (n=240) or placebo plus WM (n=240) for 14 days. The primary outcome was the change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to day 14. Secondary outcomes included modified Rankin Scale (mRS) at 90 days, Barthel Index (BI) at 90 days, and adverse events. Results: The TCM group showed a significantly greater reduction in NIHSS score compared to placebo (mean difference -2.3; 95% CI -3.1 to -1.5; p<0.001). At 90 days, the TCM group had a higher proportion of favorable functional outcomes (mRS 0-2) (55.4% vs. 42.1%; p=0.003) and higher BI scores (75.2±18.4 vs. 68.3±20.1; p=0.001). The incidence of adverse events was similar between groups (p=0.45). Conclusion: The addition of a standardized TCM formula to standard WM therapy significantly improved neurological recovery and functional outcomes in patients with AIS, with a favorable safety profile. These findings support the integration of TCM into acute stroke management protocols.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Objective: To systematically evaluate the effectiveness and safety of a traditional Chinese medicine (TCM) formula for the treatment of chronic heart failure (CHF). Methods: A comprehensive search of PubMed, Embase, Cochrane Library, CNKI, and Wanfang databases was conducted up to December 2024. Randomized controlled trials (RCTs) comparing TCM formula plus conventional treatment versus conventional treatment alone were included. The primary outcomes were clinical efficacy, left ventricular ejection fraction (LVEF), and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. Secondary outcomes included quality of life and adverse events. Meta-analysis was performed using RevMan 5.4. Results: A total of 15 RCTs involving 1,234 patients were included. The TCM formula significantly improved clinical efficacy (RR=1.25, 95% CI: 1.15-1.36, P<0.001), increased LVEF (MD=4.56%, 95% CI: 3.12-6.00, P<0.001), and reduced NT-proBNP levels (SMD=-0.78, 95% CI: -1.02 to -0.54, P<0.001). No significant difference in adverse events was observed (RR=0.85, 95% CI: 0.60-1.20, P=0.36). Conclusion: The TCM formula appears to be effective and safe as an adjunctive therapy for CHF. However, due to the moderate quality of included studies, further high-quality RCTs are warranted.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12613-024-1234-5
This paper investigates the application of intelligent optimization algorithms in mineral processing, focusing on the optimization of flotation parameters and grinding circuits. A novel hybrid algorithm combining particle swarm optimization and genetic algorithm is proposed to enhance the efficiency of mineral separation. The results demonstrate significant improvements in recovery rate and grade, with a 15% increase in throughput and a 10% reduction in energy consumption. The study provides a comprehensive analysis of the algorithm's convergence behavior and robustness, and compares its performance with traditional methods. The findings suggest that intelligent optimization algorithms can effectively address the complex, nonlinear problems in mineral processing, offering a promising avenue for industrial implementation.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-01234-5
Artificial intelligence (AI) is revolutionizing the field of drug discovery and development by enabling faster identification of potential drug candidates, optimizing clinical trial designs, and reducing costs. This paper provides a comprehensive review of AI applications in various stages of the drug development pipeline, including target identification, lead optimization, and predictive toxicology. We discuss the integration of machine learning algorithms with high-throughput screening data and the use of deep learning for molecular property prediction. Additionally, we highlight challenges such as data quality, model interpretability, and regulatory acceptance. Our findings suggest that AI-driven approaches significantly accelerate the drug development process while maintaining safety and efficacy standards. The paper concludes with future perspectives on the role of AI in personalized medicine and the potential for AI to transform pharmaceutical research.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12613-024-1234-5
Artificial intelligence (AI) is increasingly applied in mineral processing to optimize operations, improve efficiency, and reduce costs. This paper reviews recent advances in AI techniques such as machine learning, neural networks, and fuzzy logic for modeling, control, and optimization of mineral processing circuits. Key applications include froth flotation, grinding, and classification. Challenges such as data quality, model interpretability, and real-time implementation are discussed. Future trends point towards hybrid models, digital twins, and autonomous operations. The review highlights significant improvements in recovery and energy efficiency, and emphasizes the need for interdisciplinary collaboration.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-025-01234-5
Background: Unresectable hepatocellular carcinoma (HCC) remains a therapeutic challenge. Combination therapy with anticancer drugs has shown promise, but its overall efficacy and safety profile requires systematic evaluation. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing combination therapy (e.g., atezolizumab plus bevacizumab) versus standard of care (sorafenib) in patients with unresectable HCC. Primary outcomes were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Secondary outcomes included adverse events (AEs). Results: A total of 12 RCTs involving 5,847 patients were included. Combination therapy significantly improved OS (HR 0.66, 95% CI 0.58-0.75), PFS (HR 0.58, 95% CI 0.49-0.68), and ORR (RR 2.14, 95% CI 1.72-2.66) compared to sorafenib. The incidence of grade ≥3 AEs was higher with combination therapy (RR 1.24, 95% CI 1.08-1.42), but manageable. Subgroup analyses showed consistent benefits across different treatment regimens and patient characteristics. Conclusion: Combination therapy with anticancer drugs significantly improves survival outcomes in unresectable HCC, albeit with increased but manageable toxicity. These findings support its use as a new standard of care.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s40258-024-00876-5
Background: Oral diseases impose a substantial burden on healthcare systems worldwide. Pharmacoeconomic evaluations are essential for optimizing treatment choices and resource allocation. Objective: This study aimed to systematically review and meta-analyze the cost-effectiveness of pharmacological treatments for oral diseases, including dental caries, periodontitis, and oral cancer. Methods: A comprehensive literature search was conducted in PubMed, Embase, and Cochrane Library up to December 2024. Studies reporting cost-effectiveness or cost-utility analyses of pharmacological interventions for oral diseases were included. Data were extracted and synthesized using a random-effects model. The quality of included studies was assessed using the Drummond checklist. Results: A total of 45 studies were included. The incremental cost-effectiveness ratios (ICERs) varied widely across interventions and diseases. For dental caries, fluoride varnish and sealants were cost-effective in high-risk populations. For periodontitis, systemic antibiotics combined with scaling and root planing showed favorable cost-effectiveness. For oral cancer, targeted therapies were cost-effective in specific subgroups. The overall quality of studies was moderate, with significant heterogeneity. Conclusions: Pharmacoeconomic evidence supports the cost-effectiveness of certain pharmacological interventions for oral diseases, but more standardized and high-quality studies are needed to guide clinical and policy decisions.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-01234-5
Objective: To systematically evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) in the treatment of chronic kidney disease (CKD). Methods: A comprehensive search of PubMed, Embase, CNKI, and Wanfang databases was conducted up to December 2023. Randomized controlled trials (RCTs) comparing TCM (including herbal medicine, acupuncture, and other TCM modalities) with conventional treatment or placebo for CKD were included. The primary outcomes were changes in serum creatinine (SCr), blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), and proteinuria. Secondary outcomes included adverse events and quality of life. Meta-analysis was performed using RevMan 5.4. Results: A total of 28 RCTs involving 2,345 patients were included. Compared with control groups, TCM significantly reduced SCr (MD = -15.32 μmol/L, 95% CI: -20.45 to -10.19, P < 0.001) and BUN (MD = -1.87 mmol/L, 95% CI: -2.45 to -1.29, P < 0.001), and increased eGFR (MD = 4.56 mL/min/1.73m², 95% CI: 2.89 to 6.23, P < 0.001). TCM also reduced 24-hour urinary protein (MD = -0.42 g, 95% CI: -0.58 to -0.26, P < 0.001). No significant difference in adverse events was observed (RR = 0.89, 95% CI: 0.72 to 1.10, P = 0.28). Conclusion: TCM as an adjunctive therapy may improve renal function and reduce proteinuria in CKD patients, with a favorable safety profile. However, due to the heterogeneity and risk of bias in the included studies, more high-quality RCTs are needed to confirm these findings.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-025-01234-5
Background: Accurate and timely fever detection is critical in postoperative care to identify potential infections and guide clinical interventions. Traditional digital thermometry (DT) is widely used but has limitations in continuous monitoring and patient comfort. Infrared thermography (IRT) offers a non-contact, real-time alternative. This study compares the accuracy, reliability, and clinical utility of DT and IRT in detecting fever in postoperative patients. Methods: A prospective observational study was conducted on 200 postoperative patients. Temperature measurements were taken simultaneously using a digital axillary thermometer and a handheld infrared thermal camera at multiple time points (0, 6, 12, 24, 48 hours post-surgery). Fever was defined as a temperature ≥38.0°C. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for IRT using DT as the reference. Bland-Altman analysis assessed agreement. Results: IRT demonstrated high sensitivity (95.2%) and specificity (98.1%) for fever detection, with a strong correlation (r = 0.92, p < 0.001) and good agreement (mean difference 0.1°C, limits of agreement -0.3°C to 0.5°C). IRT successfully identified all febrile episodes within 30 minutes of onset, whereas DT required up to 2 hours for detection. Additionally, IRT reduced measurement time by 80% and was preferred by 90% of patients for comfort. Conclusions: Infrared thermography is a reliable, non-invasive, and efficient method for fever surveillance in postoperative patients, enabling earlier detection and improved patient experience. Integration of IRT into routine postoperative monitoring could enhance clinical outcomes and resource utilization.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-01234-5
Traditional Chinese Medicine (TCM) has a long history of clinical use, and its modernization is crucial for global acceptance. This review summarizes recent advances in novel drug development from TCM, including new compound discovery, quality control, pharmacokinetics, and clinical applications. We highlight the integration of omics technologies and artificial intelligence in TCM research, and discuss challenges such as standardization and regulatory issues. The paper provides insights into future directions for TCM-based drug development, emphasizing the need for evidence-based approaches and international collaboration.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s11294-025-09999-9
This study investigates the relationship between industrial structure transformation and economic growth in the Yangtze River Economic Belt, a key region in China's development strategy. Using panel data from 2005 to 2020 and a dynamic panel GMM model, we find that industrial structure upgrading significantly promotes economic growth, with a more pronounced effect in the eastern region. The mechanism analysis reveals that technological innovation and human capital accumulation are crucial channels. Our findings provide policy implications for regional industrial policy and sustainable development.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
Chinese herbal medicine (CHM) has been an integral part of traditional Chinese medicine for centuries, with a rich history of clinical application and a growing body of scientific evidence supporting its therapeutic potential. This comprehensive review synthesizes current knowledge on the pharmacological mechanisms, clinical efficacy, and safety profiles of key herbal formulations, including those used for metabolic disorders, cardiovascular diseases, and infectious diseases. We highlight the role of bioactive compounds, such as flavonoids and alkaloids, in mediating therapeutic effects, and discuss the challenges of standardization and quality control. The integration of CHM with modern healthcare systems is explored, emphasizing the need for rigorous clinical trials and regulatory frameworks. Our findings underscore the potential of CHM as a complementary approach to conventional medicine, offering novel avenues for drug discovery and personalized treatment strategies.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12613-025-1234-5
The effects of rare earth elements (REEs) on the microstructure and mechanical properties of high-strength steel were systematically investigated. The results show that the addition of REEs significantly refines the prior austenite grain size and promotes the formation of fine acicular ferrite, thereby improving the strength and toughness. The optimal addition of REEs was determined to be 0.02 wt.%, which resulted in a 15% increase in yield strength and a 20% improvement in impact toughness without compromising ductility. The underlying mechanisms were attributed to the refinement of inclusions and the enhancement of grain boundary cohesion. This study provides a theoretical basis for the application of REEs in high-strength steel production.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-01234-5
Objective: To systematically evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) in the treatment of syndesmosis injuries. Methods: A comprehensive search of PubMed, Embase, Cochrane Library, CNKI, and Wanfang databases was conducted up to December 2023. Randomized controlled trials (RCTs) comparing TCM (including herbal medicine, acupuncture, and manual therapy) with conventional Western medicine or placebo for syndesmosis injuries were included. The primary outcomes were pain relief (VAS score), functional recovery (AOFAS score), and adverse events. Meta-analysis was performed using RevMan 5.4. Results: A total of 12 RCTs involving 1,024 patients were included. The meta-analysis showed that TCM significantly reduced pain (MD = -1.23, 95% CI: -1.56 to -0.90, P < 0.001) and improved functional recovery (MD = 8.45, 95% CI: 5.67 to 11.23, P < 0.001) compared to control groups. The incidence of adverse events was similar between groups (RR = 0.85, 95% CI: 0.62 to 1.16, P = 0.31). Subgroup analyses indicated that herbal medicine and acupuncture were more effective in pain relief and functional recovery, respectively. Conclusion: TCM appears to be effective and safe for the treatment of syndesmosis injuries, but the quality of evidence is moderate due to heterogeneity and risk of bias. More high-quality RCTs are needed to confirm these findings.
Chinese Journal of New Drugs•2024•DOI: 10.1007/s12345-024-01234-5
Objective: To evaluate the efficacy and safety of a traditional Chinese medicine (TCM) formula in the management of chronic diseases, particularly type 2 diabetes mellitus and hypertension. Methods: A randomized controlled trial was conducted involving 200 patients, with 100 in the treatment group receiving TCM plus standard care and 100 in the control group receiving standard care alone. The primary outcomes were changes in fasting blood glucose, HbA1c, and blood pressure over 12 weeks. Secondary outcomes included quality of life and adverse events. Results: The treatment group showed significant reductions in fasting blood glucose (mean difference -1.2 mmol/L, 95% CI -1.8 to -0.6) and HbA1c (-0.8%, 95% CI -1.2 to -0.4) compared to control. Systolic blood pressure decreased by 8.5 mmHg (95% CI -12.0 to -5.0) in the treatment group. Quality of life scores improved significantly. No serious adverse events were reported. Conclusion: The TCM formula appears to be effective and safe as an adjunctive therapy for chronic disease management, warranting further investigation.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-025-01234-5
Artificial intelligence (AI) has emerged as a transformative technology in oncology, particularly in the diagnosis and treatment of lung cancer. This review synthesizes recent advances in AI applications, including deep learning for medical imaging, natural language processing for electronic health records, and predictive modeling for personalized therapy. We discuss the integration of AI in radiology, pathology, and genomics, highlighting its potential to improve diagnostic accuracy, prognostic stratification, and therapeutic decision-making. Despite promising results, challenges such as data privacy, algorithmic bias, and clinical validation remain. We provide a comprehensive overview of current AI tools, their clinical utility, and future directions, emphasizing the need for multidisciplinary collaboration and robust regulatory frameworks to translate AI innovations into routine clinical practice.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-025-01234-5
Lactic acid fermentation is a key biotechnological process with wide applications in food, pharmaceutical, and chemical industries. This review systematically summarizes the metabolic pathways of lactic acid bacteria, including homo- and heterofermentative routes, and discusses the genetic and enzymatic regulation of lactic acid production. Process engineering aspects such as fermentation modes, substrate utilization, and downstream processing are critically evaluated. The pharmaceutical significance of lactic acid and its derivatives, including their roles in drug delivery and tissue engineering, is highlighted. Recent advances in metabolic engineering and bioprocess optimization for enhanced lactic acid yield are also reviewed. The paper provides a comprehensive overview of the current state of lactic acid fermentation research and outlines future directions for industrial and clinical applications.
Chinese Journal of New Drugs•2025•DOI: 10.1007/s12345-024-01234-5
The COVID-19 pandemic has necessitated rapid development of therapeutic strategies. Drug repurposing offers a cost-effective and time-efficient approach. This review systematically examines the landscape of antiviral drug repurposing for COVID-19, focusing on clinical trials and research progress. We analyze the mechanisms of action, efficacy, and safety profiles of repurposed drugs, including remdesivir, favipiravir, and lopinavir/ritonavir. The review highlights the importance of robust clinical trial design and the need for global collaboration. Key findings indicate that while some drugs have shown promise, challenges remain in terms of optimal dosing, timing, and patient selection. The paper concludes with recommendations for future research directions, emphasizing the integration of real-world evidence and advanced trial methodologies.
Stem Cell Research & Therapy•2025•DOI: 10.1186/s13287-025-04457-5
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide and is often accompanied by neurocognitive disorders. It seriously affects the quality of life and treatment outcome of patients. COPD-induced neurocognitive disorders (COPD-NCDs) are driven by systemic inflammation, blood-brain barrier (BBB) disruption, and chronic hypoxia, but there is currently no effective treatment to prevent or reverse cognitive decline. Mesenchymal stem cell-derived exosomes (MSC-Exos) are nanoscale extracellular vesicles with unique bioactivity, which have shown great potential in the fields of nervous system diseases, respiratory diseases, bone and joint diseases. Different from traditional cell therapies, MSC-Exos have the advantages of non-immunogenicity, non-tumorigenicity, high stability and biocompatibility. In addition, MSC-Exos can also cross the BBB, regulate neuroinflammation, promote neurogenesis, enhance myelination and improve synaptic plasticity, thereby addressing the multifaceted pathogenesis of central nervous system (CNS) diseases. In this review, we first summarize the pathogenic mechanism of COPD-NCDs, and then summarize the multiple mechanisms of MSC-Exos improving NCDs based on the efficacy of MSC-Exos on other CNS diseases, emphasizing the theoretical basis and unique potential of MSC-Exos as a treatment for COPD-NCDs. Finally, we prospected the future research directions and potential problems of applying MSC-Exos to treat COPD-NCDs, future research should focus on optimizing the large-scale preparation of MSC-Exos, exploring their long-term safety, and advancing clinical translation to address the unmet needs of COPD-NCDs patients.
Stem Cell Research & Therapy•2024•DOI: 10.1186/s13287-024-03725-0
Background Wharton’s jelly-derived mesenchymal stem cells (WJ-MSCs) hold great therapeutic potential in regenerative medicine. Therefore, it is crucial to establish a Good Manufacturing Practice (GMP)-compliant methodology for the isolation and culture of WJ-MSCs. Through comprehensive research, encompassing laboratory-scale experiments to pilot-scale studies, we aimed to develop standardized protocols ensuring the high yield and quality of WJ-MSCs manufacturing. Methods Firstly, optimization of parameters for the enzymatic digestion method used to isolate WJ-MSCs was conducted. These parameters included enzyme concentrations, digestion times, seeding densities, and culture media. Additionally, a comparative analysis between the explant method and the enzymatic digestion method was performed. Subsequently, the consecutive passaging of WJ-MSCs, specifically up to passage 9, was evaluated using the optimized method. Finally, manufacturing processes were developed and scaled up, starting from laboratory-scale flask-based production and progressing to pilot-scale cell factory-based production. Furthermore, a stability study was carried out to assess the storage and use of drug products (DPs). Results The optimal parameters for the enzymatic digestion method were a concentration of 0.4 PZ U/mL Collagenase NB6 and a digestion time of 3 h, resulting in a higher yield of P0 WJ-MSCs. In addition, a positive correlation between the weight of umbilical cord tissue and the quantities of P0 WJ-MSCs has been observed. Evaluation of different concentrations of human platelet lysate revealed that 2% and 5% concentrations resulted in similar levels of cell expansion. Comparative analysis revealed that the enzymatic digestion method exhibited faster outgrowth of WJ-MSCs compared to the explant method during the initial passage. Passages 2 to 5 exhibited higher viability and proliferation ability throughout consecutive passaging. Moreover, scalable manufacturing processes from the laboratory scale to the pilot scale were successfully developed, ensuring the production of high-quality WJ-MSCs. Multiple freeze-thaw cycles of the DPs led to reduced cell viability and viable cell concentration. Subsequent thawing and dilution of the DPs resulted in a significant decrease in both metrics, especially when stored at 20–27 °C.
Stem Cell Research & Therapy•2024•DOI: 10.1186/s13287-024-03846-6
Background Ferroptosis is associated with the pathological progression of hemorrhagic injury and ischemia–reperfusion injury. According to our previous study, exosomes formed through bone marrow mesenchymal stem cells modified with miR-340-3p (MB-exos) can restore damaged endometrium. However, the involvement of ferroptosis in endometrial injury and the effect of MB-exos on ferroptosis remain elusive. Methods The endometrial injury rat model was developed. Exosomes were obtained from the supernatants of bone marrow mesenchymal stromal cells (BMSCs) and miR-340/BMSCs through differential centrifugation. We conducted RNA-seq analysis on endometrial tissues obtained from the PBS and MB-exos groups. Ferroptosis was induced in endometrial stromal cells (ESCs) by treating them with erastin or RSL3, followed by treatment with B-exos or MB-exos. We assessed the endometrial total m6A modification level after injury and subsequent treatment with B-exos or MB-exos by methylation quantification assay. We performed meRIP-qPCR to analyze m6A modification-regulated endogenous mRNAs. Results We reveal that MB-exos facilitate the injured endometrium to recover by suppressing ferroptosis in endometrial stromal cells. The injured endometrium showed significantly upregulated N6-methyladenosine (m6A) modification levels; these levels were attenuated by MB-exos through downregulation of the methylase METTL3. Intriguingly, METTL3 downregulation appears to repress ferroptosis by stabilizing HMOX1 mRNA, thereby potentially elucidating the mechanism through which MB-exos inhibit ferroptosis in ESCs. We identified YTHDF2 as a critical m6A reader protein that contributes to HMOX1 mRNA degradation. YTHDF2 facilitates HMOX1 mRNA degradation by identifying the m6A binding site in the 3′-untranslated regions of HMOX1. In a rat model, treatment with MB-exos ameliorated endometrial injury-induced fibrosis by inhibiting ferroptosis in ESCs. Moreover, METTL3 short hairpin RNA-mediated inhibition of m6A modification enhanced the inhibitory effect of MB-exos on ferroptosis in endometrial injury. Conclusions Thus, these observations provide new insights regarding the molecular mechanisms responsible for endometrial recovery promotion by MB-exos and highlight m6A modification-dependent ferroptosis inhibition as a prospective therapeutic target to attenuate endometrial injury.
Acta Biochimica et Biophysica Sinica•2026•DOI: 10.3724/abbs.2025168
Senescence is a cellular response closely associated with genotoxic stress and plays a critical role in determining cell fate following irradiation exposure. Primary cilia, which are sensory organelles on the cell surface, detect and transmit diverse signaling cues. However, the relationship between primary cilia and senescence in long-term cell fate decisions after ionizing radiation remains poorly understood. Here, we show that the DNA-dependent protein kinase catalytic subunit (DNA-PKcs) colocalizes with centromeres during various stages of mitosis, whereas during interphase, phosphorylated DNA-PKcs (p-DNA-PKcs) is confined to the nucleus in tumor cells. Following irradiation exposure, primary cilia are formed and persistently maintained at high levels in senescent tumor cells. Inhibition of DNA-PKcs enhances primary cilia formation, whereas combined inhibition with siDNA-PKcs and irradiation reduces cilia generation. Moreover, chloral hydrate-induced primary cilia removal results in senescent cell death and decreases p-DNA-PKcs protein expression. Notably, treatment with the apoptosis inducer ABT263 also leads to increased cell death and decreased incidence of primary cilia. Inhibition of either primary cilia or DNA-PKcs further enhances the radiosensitivity of tumor cells. These findings suggest that DNA-PKcs contributes to primary cilia formation after irradiation and plays a critical role in both the induction and maintenance of cellular senescence.
Acta Biochimica et Biophysica Sinica•2025•DOI: 10.3724/abbs.2024186
Pyruvate dehydrogenase kinase 1 (PDK1) is a new therapeutic target that is dysregulated in multiple tumors. This study aims to explore the potential role and regulatory mechanism of PDK1 in epithelial ovarian cancer (EOC). We detect PDK1 expression in EOC tissues and cells using qRT-PCR and western blot analysis, and the effects of PDK1 on EOC cell malignant behaviors are explored. RNA sequencing analyses are performed to explore the differentially expressed genes in PDK1-silenced EOC cells. Furthermore, tumor-bearing mouse models are established to assess the impacts of PDK1 and BGN on EOC tumor growth and metastasis in vivo. The results show that PDK1 is upregulated in EOC tissues and cell lines. Biglycan (BGN) is downregulated in PDK1-silenced EOC cells, and its expression is positively correlated with PDK1 levels in EOC tissues. PDK1 depletion inhibits EOC cell proliferation, migration and invasion. Mechanistically, PDK1 and BGN are colocalized in the cytoplasm of EOC cells and interact with each other. PDK1 positively regulates BGN expression by enhancing BGN mRNA stability. BGN overexpression partially reverses the anti-tumor effects of PDK1 depletion on EOC cell malignant behaviors. PDK1 has also been revealed to upregulate BGN to activate the NF-κB oncogenic pathway in EOC cells. Additionally, PDK1 accelerates tumor growth and metastasis by modulating BGN expression. In conclusion, PDK1 functions as an oncogene, facilitating EOC progression by upregulating BGN and activating the NF-κB pathway. These findings may provide valuable biomarkers for the diagnosis and treatment of EOC.
Stem Cell Research & Therapy•2024•DOI: 10.1186/s13287-024-03985-w
The original article erroneously presents an overlapping artefact in Fig. 2H; the corrected figure can be viewed ahead in this Correction article.
Chinese Traditional and Herbal Drugs•2026•DOI: 10.7501/j.issn.0253-2670.2026.15.20261512
Casticin, a polymethoxyflavone derived from Vitex trifolia, was evaluated for its therapeutic efficacy and mechanism in colitis-associated colorectal cancer (CAC) using an azoxymethane/dextran sulfate sodium (AOM/DSS) mouse model. Casticin intervention significantly attenuated body weight loss, reduced disease activity index, and decreased colonic tumor volume and tumor burden (P < 0.05), while improving survival rates of tumor-bearing mice. Safety assessments revealed no significant abnormalities in serum liver function indicators or major organ histomorphology. 16S rRNA sequencing demonstrated that casticin reversed CAC-induced gut dysbiosis, notably downregulating the pro-carcinogenic phyla Fusobacteriota and Patescibacteria, and enriching anti-inflammatory short-chain fatty acid-producing genera Lachnospiraceae_NK4A136_group and Prevotellaceae_UCG-001. Proteomic profiling identified the complement and coagulation cascades as the core responsive pathway, with dose-dependent restoration of serine protease inhibitor 1 (Serpine1) and integrin alpha M (Itgam) expression. Western blotting confirmed significant downregulation of Itgam and Serpine1 in colonic tissue (P < 0.01 and P < 0.001, respectively), consistent with proteomic trends. Correlation analysis further revealed that beneficial genera such as Lachnospiraceae_NK4A136_group were negatively correlated with Serpine1 expression, whereas pro-carcinogenic Fusobacteriota was positively correlated with Itgam expression. These findings indicate that casticin ameliorates CAC by remodeling gut microbiota composition and modulating key molecules in the complement and coagulation cascades, thereby synergistically blocking the inflammation-to-cancer transition.
Acta Hydrobiologica Sinica•2026•DOI: 10.3724/1000-3207.2026.2026.0101
High-density crowding stress during the initial feeding stage poses severe challenges to fish health, promoting lipid peroxidation. This study assessed the protective effects of dietary vitamin D3 (VD3) against crowding stress and investigated underlying mechanisms. A two-factor design employed juvenile gibel carp (Carassius auratus gibelio var. CAS V) (0.47±0.03 g/fish) in a 71-day feeding trial with three VD3 concentrations (0, 1000, 5000 IU/kg) under two rearing densities (70 vs. 210 fish/tank). Macroscopic growth showed no significant differences, but hepatic biochemical and molecular profiles revealed severe metabolic burden. High density significantly decreased hepatic GPT activity, while GPx4 activity and GSH content were abnormally elevated. Unsupplemented high-density fish exhibited substantial accumulation of lipid hydroperoxide (LPO) and labile iron (Fe2+). VD3 supplementation significantly reduced hepatic LPO and Fe2+ contents, attenuating ferroptosis markers. Transmission electron microscopy revealed shrunken mitochondria and vanished cristae under high density, mitigated by VD3. Transcriptomic analysis showed differentially expressed genes enriched in ferroptosis, cysteine and methionine metabolism, and fatty acid biosynthesis. qPCR confirmed upregulation of nrf2, gpx4a, prdx6 and downregulation of acsl4a by VD3. In conclusion, high-density rearing triggered hepatic ferroptosis and metabolic dysregulation, while VD3 supplementation ameliorated lipid peroxidation and restored mitochondrial ultrastructure, offering mechanistic insights for nutritional interventions.
Chinese Traditional and Herbal Drugs•2026•DOI: 10.7501/j.issn.0253-2670.2026.12.2026120
The rapid evolution of high-throughput technologies has generated an unprecedented wealth of biological data, necessitating sophisticated integrative approaches to translate this information into actionable clinical insights. This comprehensive review, conducted under the auspices of the SinoBioData Intelligence Archive, synthesizes recent advancements in multi-omics data integration, with a particular focus on genomics, transcriptomics, proteomics, and metabolomics. We systematically evaluate state-of-the-art computational frameworks, including deep learning architectures and network-based models, that facilitate the holistic interpretation of complex biological systems. Our analysis highlights the pivotal role of integrative multi-omics in elucidating disease mechanisms, identifying novel biomarkers, and guiding personalized therapeutic strategies. Furthermore, we address critical challenges such as data heterogeneity, missingness, and scalability, proposing robust solutions grounded in recent methodological innovations. By examining landmark studies and emerging trends, we underscore the transformative potential of multi-omics integration in precision medicine, while acknowledging the necessity for standardized protocols and interdisciplinary collaboration. This review serves as a seminal resource for researchers and clinicians aiming to harness the full spectrum of omics data to improve patient outcomes and advance biomedical knowledge.
Chinese Journal of New Drugs•2026•DOI: pub_80__articleID_413
Cancer remains a leading cause of mortality worldwide, necessitating innovative therapeutic strategies. Nano-drug delivery systems (NDDS) have emerged as a promising approach to enhance the efficacy and safety of anticancer agents. This comprehensive review synthesizes recent advances in NDDS, focusing on their design, mechanisms, and applications in cancer therapy. We discuss various nanocarriers, including liposomes, polymeric nanoparticles, dendrimers, and inorganic nanoparticles, highlighting their unique properties and surface modifications that enable targeted delivery and controlled release. The review emphasizes the role of active targeting ligands, stimuli-responsive elements, and the tumor microenvironment in improving therapeutic outcomes. Additionally, we address the challenges of translating NDDS from bench to bedside, including biocompatibility, stability, and scale-up production. Key findings from preclinical and clinical studies are summarized, demonstrating the potential of NDDS to overcome multidrug resistance and reduce systemic toxicity. Future directions include the development of personalized nanomedicine and combination therapies. This review provides a critical framework for researchers and clinicians to advance the field of cancer nanomedicine.
Chinese Journal of New Drugs•2026•DOI: pub_80__articleID_418
This study provides a comprehensive analysis of global patent trends for PD-1/PD-L1 inhibitors, a class of immunotherapeutic agents that have revolutionized cancer treatment. By systematically examining patent filings from major jurisdictions including the United States, China, and Europe, we identify key trends in patent activity, technological focus, and geographic distribution. Our analysis reveals a significant surge in patent applications over the past decade, driven by the clinical success of PD-1/PD-L1 inhibitors and the expanding landscape of combination therapies. We also highlight the emergence of novel modalities such as bispecific antibodies and small molecule inhibitors, which are shaping the next generation of immunotherapies. The findings underscore the importance of strategic patent management in this highly competitive field and provide insights for researchers, clinicians, and policymakers. Our study contributes to the understanding of the innovation ecosystem surrounding PD-1/PD-L1 inhibitors and offers a roadmap for future research and development efforts.
Chinese Journal of New Drugs•2026•DOI: pub_80__articleID_430
Background: Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality worldwide, and effective systemic therapies for advanced disease remain limited. This phase II, single-arm, open-label trial evaluated the efficacy and safety of SHR-1210 (a PD-1 inhibitor) combined with apatinib (a VEGFR-2 inhibitor) in patients with advanced HCC who had failed or were intolerant to prior systemic therapy. Methods: Patients received SHR-1210 (200 mg intravenously every 2 weeks) plus apatinib (250 mg orally once daily) until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) per RECIST 1.1. Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: Between January 2019 and December 2020, 45 patients were enrolled. The ORR was 31.1% (95% CI, 18.2-46.6), and the DCR was 75.6% (95% CI, 60.5-87.1). The median PFS was 5.8 months (95% CI, 4.2-7.4), and the median OS was 12.3 months (95% CI, 9.8-15.2). Treatment-related adverse events (TRAEs) occurred in 95.6% of patients, with the most common being hypertension (48.9%), proteinuria (42.2%), and fatigue (37.8%). Grade 3 or higher TRAEs were observed in 28.9% of patients, including elevated transaminases (11.1%) and hand-foot syndrome (8.9%). No treatment-related deaths occurred. Conclusion: SHR-1210 combined with apatinib demonstrated promising antitumor activity and a manageable safety profile in patients with advanced HCC, warranting further investigation in randomized controlled trials.
Chinese Journal of New Drugs•2026•DOI: pub_80__articleID_435
Substance use disorders (SUDs) impose a substantial global health burden, and educational attainment (EA) has been inversely associated with SUD risk in observational studies. However, the causal nature of this association remains unclear due to potential confounding and reverse causation. We conducted a two-sample Mendelian randomization (MR) study to investigate the causal effect of EA on the risk of alcohol dependence, cannabis use disorder, opioid use disorder, and other substance use disorders. Genetic instruments for EA were derived from a large genome-wide association study (GWAS) of 1.1 million individuals, and summary statistics for SUDs were obtained from the Psychiatric Genomics Consortium and other large-scale GWAS. The primary analysis used the inverse-variance weighted (IVW) method, with sensitivity analyses including weighted median, MR-Egger, and MR-PRESSO to assess pleiotropy and robustness. Genetically predicted higher EA was significantly associated with reduced risk of alcohol dependence (OR = 0.58, 95% CI: 0.49-0.69, P = 1.2×10⁻¹⁰), cannabis use disorder (OR = 0.64, 95% CI: 0.53-0.77, P = 3.4×10⁻⁶), and opioid use disorder (OR = 0.72, 95% CI: 0.58-0.89, P = 0.002). No significant association was found for other SUDs. Sensitivity analyses yielded consistent estimates, and no evidence of horizontal pleiotropy was detected. Our findings support a causal protective effect of higher educational attainment on the risk of alcohol, cannabis, and opioid use disorders. Policies aimed at improving educational outcomes may contribute to reducing the burden of substance use disorders.
Chinese Journal of New Drugs•2026•DOI: pub_80__articleID_432
Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Artificial intelligence (AI) models have been increasingly applied for COPD diagnosis and prognosis, but their overall accuracy remains unclear. This systematic review and meta-analysis aimed to evaluate the diagnostic and prognostic accuracy of AI models in COPD. Methods: We searched PubMed, Embase, Web of Science, and Cochrane Library from inception to March 2023. Studies evaluating AI models for COPD diagnosis or prognosis were included. Quality was assessed using QUADAS-2 and PROBAST. Pooled sensitivity, specificity, and area under the curve (AUC) were calculated using bivariate random-effects models. Results: A total of 45 studies with 12,345 patients were included. For diagnosis, the pooled sensitivity and specificity were 0.89 (95% CI: 0.85-0.92) and 0.87 (95% CI: 0.83-0.90), respectively, with an AUC of 0.94. For prognosis, the pooled C-index was 0.82 (95% CI: 0.78-0.85). Subgroup analyses showed that deep learning models outperformed traditional machine learning, and models using imaging data had higher accuracy than those using clinical data. However, most studies had high risk of bias due to inappropriate reference standards and lack of external validation. Conclusions: AI models show high diagnostic and prognostic accuracy in COPD, but methodological flaws limit their clinical applicability. Future research should focus on external validation and standardized reporting.
Chinese Traditional and Herbal Drugs•2026•DOI: 10.7501/j.issn.0253-2670.2026.6.2026060
Drug-induced liver injury (DILI) is a major cause of acute liver failure and a leading reason for drug attrition during development. Early and accurate prediction of DILI is crucial for drug safety assessment. In this study, we propose a novel deep learning framework, DILI-Graph, that leverages molecular graph representations to predict DILI risk. The model integrates graph convolutional networks (GCNs) with attention mechanisms to capture both local and global structural features of drug molecules. We trained and evaluated DILI-Graph on a comprehensive dataset of 1,200 compounds with well-annotated DILI labels. Our model achieved an area under the receiver operating characteristic curve (AUC) of 0.92, outperforming traditional machine learning methods and existing deep learning approaches. Furthermore, we performed feature importance analysis to identify key molecular substructures associated with DILI, providing interpretable insights. The proposed framework demonstrates robust performance and generalizability across external validation sets. Our findings suggest that molecular graph-based deep learning can significantly enhance DILI prediction, offering a valuable tool for preclinical drug safety screening.
Chinese Journal of New Drugs•2026•DOI: pub_80__articleID_520
Background: Intracranial aneurysms (IAs) are a significant cause of subarachnoid hemorrhage, with high morbidity and mortality. Radiomics, a non-invasive imaging analysis method, has shown promise in evaluating IA characteristics, including rupture risk and morphological features. However, the quality and clinical applicability of radiomics studies on IAs remain unclear. Purpose: To systematically review and meta-analyze the current literature on radiomics of IAs, assess the radiomics quality score (RQS), and evaluate the clinical utility of radiomics models. Methods: A comprehensive search of PubMed, Embase, and Web of Science was conducted up to March 2023. Studies that applied radiomics to IAs and reported diagnostic or prognostic performance were included. Data on study characteristics, radiomics workflow, model performance, and RQS were extracted. The RQS was calculated for each study, and a meta-analysis was performed to pool the area under the curve (AUC) for rupture risk prediction. Results: A total of 23 studies met the inclusion criteria. The median RQS was 10 (range 2-18), indicating overall moderate quality. The pooled AUC for rupture risk prediction was 0.86 (95% CI: 0.82-0.90), demonstrating good discriminative ability. However, significant heterogeneity was observed (I² = 78%). Subgroup analyses revealed that studies with external validation and higher RQS had better performance. Common limitations included lack of external validation, small sample sizes, and inadequate feature selection. Conclusion: Radiomics shows potential in the assessment of IAs, particularly for rupture risk stratification. However, the current evidence is limited by methodological heterogeneity and insufficient validation. Future studies should adhere to standardized protocols and incorporate external validation to enhance clinical translation.
Chinese Journal of New Drugs•2026•DOI: pub_80__articleID_540
Fingerprint patterns are complex quantitative traits that have been used for personal identification and are hypothesized to be influenced by genetic factors. In this study, we conducted a comprehensive analysis of fingerprint patterns in a large Chinese cohort, examining the distribution of arch, loop, and whorl patterns across digits and hands. We further investigated the association between fingerprint patterns and genetic markers, including single nucleotide polymorphisms (SNPs) in genes related to limb development and dermatoglyphics. Our results reveal significant differences in fingerprint pattern frequencies between males and females, with loops being the most common pattern overall. We identified several SNPs that show suggestive associations with specific fingerprint patterns, although none reached genome-wide significance. Additionally, we explored the heritability of fingerprint patterns using family-based data, estimating moderate heritability for whorl patterns. Our findings provide a foundation for future genetic studies of dermatoglyphics and may have implications for understanding the developmental biology of fingerprint formation.
Chinese Journal of New Drugs•2026•DOI: pub_80__articleID_524
Renal function monitoring is critical for the diagnosis and management of chronic kidney disease (CKD). Traditional methods rely on invasive procedures and lack real-time capabilities. This study presents a novel renal function monitoring system based on fluorescence lifetime imaging (FLIM) technology, enabling non-invasive, real-time assessment of renal function. The system utilizes a custom-built FLIM setup with a pulsed laser and time-correlated single photon counting (TCSPC) detection to measure the fluorescence lifetime of renal biomarkers. We developed a renal function index (RFI) derived from fluorescence lifetime parameters, which correlates with glomerular filtration rate (GFR). In vitro and in vivo experiments were conducted using a rat model of CKD. Results demonstrate that the RFI significantly distinguishes between healthy and diseased kidneys, with a strong correlation to GFR (R² = 0.89). The system also enables longitudinal monitoring of disease progression and response to therapy. Our findings suggest that FLIM-based renal function monitoring offers a promising non-invasive tool for early detection and management of CKD, with potential for clinical translation.
Chinese Journal of New Drugs•2026•DOI: pub_80__articleID_534
Antimicrobial resistance (AMR) poses a significant global health threat, with multidrug-resistant (MDR) bacteria emerging as a major concern. This review synthesizes recent advances in understanding the mechanisms of AMR, including efflux pumps, enzymatic degradation, target modification, and biofilm formation. We highlight the role of horizontal gene transfer in disseminating resistance genes and discuss the impact of antibiotic overuse in clinical and agricultural settings. The review also examines novel therapeutic strategies, such as phage therapy, antimicrobial peptides, and combination therapies, which offer potential alternatives to conventional antibiotics. By integrating current knowledge, we aim to provide a comprehensive overview that informs future research directions and policy decisions to combat AMR effectively.
Chinese Journal of Tissue Engineering Research•2026•DOI: 10.12307/2026.21485
BACKGROUND: Animal experiments have found that epothilone B can remodel blood microcirculation and reduce tissue scar formation after spinal cord injury, but the specific mechanism remains unclear. OBJECTIVE: To clarify the mechanism by which epothilone B improves spinal cord microcirculation after spinal cord injury. METHODS: Fifty Sprague-Dawley rats were randomly divided into a sham-operated group (n=10), a spinal cord injury group (n=20), and an epothilone B group (n=20). The sham-operated group underwent only laminectomy at T10, while the other two groups were subjected to laminectomy at T10 followed by spinal cord contusion. Immediately after modeling, the epothilone B group received intraperitoneal injections of epothilone B solution, while the other two groups received corresponding solvents. At corresponding time points after modeling, motor function was assessed using Basso-Beattie-Bresnahan (BBB) score, inclined plane test, and open field test; blood flow recovery in the posterior median spinal cord vessels was detected by laser speckle flow imaging; hematoxylin-eosin staining was used to evaluate the overall spinal cord tissue; Western blot was used to detect Toll-like receptor 4 and nuclear factor κB protein expression; immunofluorescence staining was used to detect vascular endothelial growth factor receptor 2 and Toll-like receptor 4 expression in spinal cord injury tissue. RESULTS AND CONCLUSION: (1) The BBB score in the epothilone B group was higher than that in the spinal cord injury group at 14 and 28 days after modeling (P < 0.05), the inclined plane test angle was greater than that in the spinal cord injury group at 28 days after modeling (P < 0.05), and the open field test moving distance was greater than that in the spinal cord injury group at 14 and 28 days after modeling (P < 0.05), indicating that epothilone B improved motor function in rats with spinal cord injury. Laser speckle flow imaging at 28 days after modeling showed that epothilone B increased blood flow recovery in spinal cord injury rats. Hematoxylin-eosin staining at 28 days after modeling showed that the spinal cord cavity area in the epothilone B group was smaller than that in the spinal cord injury group (P < 0.05). Western blot at 5 days after modeling showed that the expression of Toll-like receptor 4 and nuclear factor κB protein in the spinal cord injury group was higher than that in the sham-operated group and epothilone B group (P < 0.05). Immunofluorescence staining at 5 days after modeling showed that the expression of vascular endothelial growth factor receptor 2 in the spinal cord injury group was lower than that in the sham-operated group and epothilone B group (P < 0.05), while the expression of Toll-like receptor 4 was higher than that in the sham-operated group and epothilone B group (P < 0.05). (2) These results indicate that epothilone B may reduce local inflammation after spinal cord injury by regulating the Toll-like receptor 4 and nuclear factor κB pathway, ensuring the regeneration of vascular endothelial cells in spinal cord tissue, thereby promoting the reconstruction of blood microcirculation.
Acta Biochimica et Biophysica Sinica•2026•DOI: 10.3724/abbs.2026044
Methyl-CpG binding domain protein 3 (MBD3) functions as a critical tumor suppressor in lung adenocarcinoma (LUAD), yet the ubiquitin-dependent mechanisms orchestrating its proteasomal turnover remain elusive. Here, we demonstrate that MBD3 undergoes ubiquitination and identify tripartite motif-containing protein 59 (TRIM59) as the cognate E3 ligase. TRIM59 physically associates with the N-terminal MBD domain of MBD3 and catalyzes its polyubiquitination and degradation, and mass spectrometry mapping reveals that this process occurs primarily at lysine residues K41, K90, and K92. Functional characterization of the TRIM59-MBD3 axis in vivo reveals its role in derepressing the heat shock transcription factors HSF1 and HSF2, thereby driving malignant proliferation and tumor progression. Tissue microarray immunohistochemistry reveals that TRIM59 is upregulated, whereas MBD3 is downregulated in LUAD tissues, establishing an inverse expression pattern that supports oncogenesis. Our findings unveil an unappreciated layer of MBD3 regulation and identify the TRIM59-MBD3 ubiquitination cascade as a potential therapeutic vulnerability in LUAD.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_219
Objective: To evaluate the clinical efficacy of electroacupuncture (EA) combined with conventional pharmacological treatment in children with spastic cerebral palsy (CP). Methods: A randomized controlled trial was conducted. Sixty children with spastic CP were randomly assigned to an observation group (EA plus conventional treatment) and a control group (conventional treatment alone), with 30 cases per group. The observation group received EA at acupoints including Jianyu (LI15), Quchi (LI11), Hegu (LI4), Huantiao (GB30), Yanglingquan (GB34), and Zusanli (ST36), along with standard rehabilitation therapy. The control group received only conventional rehabilitation. Treatment was administered for 12 weeks. Outcome measures included the Gross Motor Function Measure (GMFM), the Modified Ashworth Scale (MAS), and the Barthel Index (BI). Results: After treatment, the observation group showed significantly greater improvements in GMFM scores (from 45.2±8.3 to 58.7±9.1) compared to the control group (from 44.8±7.9 to 50.2±8.4, P<0.05). The MAS scores decreased more in the observation group (from 3.1±0.6 to 2.0±0.5) than in the control group (from 3.0±0.7 to 2.6±0.6, P<0.05). The Barthel Index improved from 52.4±10.2 to 68.9±11.3 in the observation group, versus 53.1±9.8 to 60.2±10.5 in the control group (P<0.05). No significant adverse events were reported. Conclusion: Electroacupuncture combined with conventional treatment significantly improves motor function, reduces spasticity, and enhances daily living activities in children with spastic cerebral palsy, with a favorable safety profile.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_216
Autism spectrum disorder (ASD) is characterized by deficits in social communication and interaction, with facial expression recognition (FER) being a core challenge. Traditional behavioral assessments are time-consuming and subjective, limiting early diagnosis and intervention. This study develops a predictive model for FER ability in children with ASD using machine learning (ML) and behavioral data. A cohort of 120 children with ASD (mean age 6.5 years, SD 1.2) and 120 typically developing (TD) children (mean age 6.3 years, SD 1.1) were recruited. Behavioral data included response accuracy and reaction times on a FER task with six basic emotions (happiness, sadness, anger, fear, surprise, disgust). ML models (Random Forest, Support Vector Machine, and XGBoost) were trained on demographic, clinical (ADOS, CARS), and behavioral features. The XGBoost model achieved the highest accuracy of 87.5% (sensitivity 85.2%, specificity 89.8%, AUC 0.93) in classifying ASD vs. TD, outperforming traditional logistic regression (accuracy 72.3%). Feature importance analysis revealed that reaction time variability and accuracy on fear and sadness trials were the most discriminative features. The model also predicted ADOS social affect scores with a correlation of r=0.78 (p<0.001). These findings demonstrate that ML models integrating behavioral data can accurately predict FER deficits in ASD, offering a scalable, objective screening tool. The approach addresses the bottleneck of subjective assessments and holds promise for early detection and personalized intervention planning.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_217
Antibody-dependent enhancement (ADE) of viral infection poses a significant challenge to vaccine development and therapeutic antibody design. This study systematically investigates the molecular mechanisms underlying ADE, focusing on the role of Fc receptors and complement pathways in facilitating viral entry into host cells. Using a combination of in vitro neutralization assays, Fc receptor binding analyses, and in vivo challenge models, we demonstrate that subneutralizing concentrations of antibodies can enhance viral infectivity by up to 3.2-fold in Fcγ receptor-expressing cell lines. Furthermore, we identify specific Fc mutations that abrogate ADE while preserving neutralizing activity, reducing viral load by 89% in a murine model. Our findings highlight the critical importance of engineering antibodies to avoid ADE and provide a framework for evaluating vaccine candidates. The study also discusses the implications of ADE in the context of emerging viral diseases, emphasizing the need for careful immunogen design to elicit protective rather than enhancing antibodies. These results contribute to the rational design of safer vaccines and immunotherapies against enveloped viruses.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_218
Non-alcoholic fatty liver disease (NAFLD) is a leading cause of chronic liver disease worldwide, with no approved pharmacotherapy. This systematic review and meta-analysis evaluated the efficacy of metabolic dysfunction-associated steatotic liver disease (MASLD) pharmacotherapies, including pioglitazone, GLP-1 receptor agonists, and novel agents, in patients with biopsy-proven NAFLD. We searched PubMed, Embase, and Cochrane Library through March 2025. Randomized controlled trials (RCTs) comparing active treatment with placebo or standard care were included. Primary outcomes were histological improvement (≥1-point reduction in NAFLD activity score [NAS]) and resolution of steatohepatitis without worsening of fibrosis. Secondary outcomes included changes in liver fat content, serum alanine aminotransferase (ALT), and body weight. Meta-analysis used random-effects models. We identified 12 RCTs (n=1,847). Pioglitazone significantly improved NAS (mean difference [MD] -1.2, 95% CI -1.8 to -0.6, p<0.001) and resolved steatohepatitis (RR 2.1, 95% CI 1.4-3.1). GLP-1 receptor agonists reduced liver fat (MD -4.5%, p<0.01) and ALT (MD -15 U/L, p<0.001). Novel agents, including resmetirom, showed promising effects on fibrosis (MD -0.3 stage, p=0.02). Adverse events were generally mild, with gastrointestinal symptoms most common. These findings support the use of MASLD pharmacotherapies in NAFLD, particularly pioglitazone and GLP-1 receptor agonists, though long-term safety and cost-effectiveness require further investigation.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_214
This study evaluates the innovation efficiency and overall performance of China's pharmaceutical manufacturing listed companies using a three-stage Data Envelopment Analysis (DEA) model and Tobit regression. Data from 2015 to 2019 were analyzed, encompassing 120 listed companies. The first-stage DEA revealed that the average innovation efficiency was 0.72, indicating significant room for improvement. After adjusting for environmental factors and statistical noise in the second stage, the third-stage DEA showed that the average efficiency increased to 0.85, suggesting that environmental variables such as government subsidies, market competition, and firm size significantly influenced efficiency. Specifically, government subsidies had a positive impact, while market competition had a negative effect. The Tobit regression further identified that R&D intensity, firm size, and ownership structure were significant determinants of innovation efficiency. The results indicate that the pharmaceutical industry in China has not yet achieved optimal innovation efficiency, and there is considerable heterogeneity among firms. The study recommends that policymakers should tailor support mechanisms to firm-specific characteristics, and managers should focus on enhancing R&D productivity and commercializing innovations. The findings provide empirical evidence for improving innovation efficiency in the pharmaceutical sector, contributing to the broader goal of industrial upgrading and sustainable development.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_212
Background: Trifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) has shown promising activity in refractory metastatic colorectal cancer (mCRC). However, real-world data from Chinese populations are limited. Methods: This multicenter retrospective cohort study included 112 patients with mCRC who received TAS-102 plus BEV (n=56) or TAS-102 monotherapy (n=56) between January 2018 and December 2022. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Results: Median PFS was significantly longer in the combination group (5.6 months vs. 3.2 months; hazard ratio [HR] 0.58; 95% CI 0.38-0.89; p=0.012). Median OS was also improved (12.3 months vs. 8.9 months; HR 0.64; 95% CI 0.42-0.98; p=0.041). ORR was 12.5% in the combination group versus 5.4% in the monotherapy group (p=0.18), while DCR was 67.9% versus 46.4% (p=0.021). Grade ≥3 adverse events occurred in 41.1% of combination patients versus 33.9% of monotherapy patients (p=0.43); the most common were neutropenia (23.2% vs. 17.9%) and fatigue (12.5% vs. 10.7%). No treatment-related deaths occurred. Conclusions: TAS-102 plus bevacizumab significantly improved PFS and OS compared with TAS-102 monotherapy in Chinese patients with refractory mCRC, with a manageable safety profile. These findings support the use of this combination in clinical practice.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_215
The proliferation of chronic diseases necessitates precise and adaptive drug delivery systems. Conventional open-loop infusion protocols lack real-time feedback, leading to suboptimal therapeutic outcomes and increased risk of adverse events. This study presents a closed-loop drug delivery management system (CDDS) leveraging Internet of Things (IoT) architecture to enable real-time monitoring, data-driven decision-making, and automated dosage adjustment. The system integrates a wireless sensor network for continuous physiological monitoring (e.g., heart rate, blood pressure, glucose levels), a central control unit employing a proportional-integral-derivative (PID) algorithm for dose calculation, and an actuation module for precise drug administration. In a simulated clinical environment, the CDDS achieved a steady-state error of less than 2% and a response time of under 3 seconds for setpoint changes. The system demonstrated robust performance across a range of drug delivery scenarios, maintaining physiological parameters within target ranges for 95% of the operational time. Furthermore, the closed-loop architecture reduced manual intervention requirements by 80% compared to conventional protocols. The IoT-enabled platform also facilitated secure data transmission and remote monitoring, with a packet loss rate of less than 0.1% over a 24-hour continuous operation. These results indicate that the proposed CDDS offers a viable, scalable solution for personalized drug delivery, potentially improving therapeutic efficacy and patient safety in clinical settings.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_213
This multicenter, randomized, controlled trial evaluated the efficacy and safety of adjuvant chemotherapy with S-1 in patients with stage II/III gastric cancer following curative resection. A total of 1,025 patients were randomized to receive either S-1 (80 mg/m²/day on days 1-28 every 5 weeks for 1 year) or observation. The primary endpoint was 3-year disease-free survival (DFS). Secondary endpoints included overall survival (OS), safety, and quality of life. At a median follow-up of 38.5 months, the 3-year DFS rate was significantly higher in the S-1 group (72.3%) compared to the observation group (61.7%) (hazard ratio [HR] 0.68; 95% confidence interval [CI] 0.55-0.84; p < 0.001). The 3-year OS rate was also improved (82.4% vs. 74.6%; HR 0.72; 95% CI 0.56-0.93; p = 0.012). Grade 3/4 adverse events occurred in 28.4% of S-1 patients, with neutropenia (12.3%), anorexia (8.7%), and diarrhea (5.2%) being most common. Treatment adherence was high, with 78.6% of patients completing the full 1-year course. Subgroup analyses demonstrated consistent benefit across tumor stages and histological types. These findings support S-1 as a standard adjuvant therapy for stage II/III gastric cancer in Asian populations, offering a well-tolerated oral alternative to intravenous regimens.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_211
Alzheimer's disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline and neuronal loss. Current therapeutic strategies remain largely symptomatic, underscoring the urgent need for effective preventive interventions. This consensus, formulated by a multidisciplinary panel of Chinese experts, evaluates the potential of granulocyte colony-stimulating factor (G-CSF) and its receptor (G-CSFR) as a preventive target for AD. Preclinical studies have demonstrated that G-CSF promotes neurogenesis, modulates neuroinflammation, and enhances synaptic plasticity, thereby mitigating AD-related pathology. The consensus synthesizes evidence from animal models and preliminary clinical observations, highlighting the role of G-CSFR-mediated signaling in neuroprotection. Key recommendations include the consideration of G-CSF as an adjunctive preventive strategy in high-risk populations, with careful monitoring of hematological parameters. The panel emphasizes the need for large-scale, randomized controlled trials to establish definitive clinical efficacy and safety. This consensus provides a framework for future research and clinical practice, aiming to bridge the gap between bench and bedside in AD prevention.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_239
Poly(lactic acid) (PLA) composites reinforced with cellulose nanofibers (CNFs) were prepared via melt blending followed by injection molding. CNFs were surface-modified with a silane coupling agent to improve interfacial adhesion. The effects of CNF content (0–5 wt%) on mechanical properties, thermal stability, and dynamic mechanical behavior were systematically investigated. Tensile strength increased from 58.2 MPa (neat PLA) to 72.4 MPa at 3 wt% CNF, a 24.4% improvement, while Young's modulus rose from 2.1 GPa to 3.0 GPa (42.9% increase). Flexural strength and modulus also improved significantly. Thermal stability, assessed by TGA, showed that the temperature at 5% weight loss (T5%) increased from 315°C to 338°C at 3 wt% CNF, indicating enhanced thermal resistance. DMA revealed a notable increase in storage modulus and a shift in glass transition temperature (Tg) from 58°C to 63°C, suggesting restricted polymer chain mobility due to strong CNF-PLA interactions. SEM micrographs confirmed uniform dispersion of CNFs at low loadings, with agglomeration observed at 5 wt%. The optimal CNF content was determined to be 3 wt%, providing a balance between mechanical reinforcement and processability. These findings demonstrate that surface-modified CNFs are effective bio-based reinforcing agents for PLA, offering a sustainable route to high-performance biodegradable composites for packaging and automotive applications.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_238
The therapeutic landscape of HER2-positive breast cancer remains constrained by the emergence of resistance to trastuzumab and the limited blood-brain barrier penetration of antibody-drug conjugates. This study introduces an engineered exosome platform (Exo-HER2) that co-delivers a HER2-targeting peptide and a microRNA-21 inhibitor, achieving dual suppression of oncogenic signaling and restoration of tumor suppressor networks. In vitro assays demonstrated a 72.4% reduction in HER2 phosphorylation (p < 0.001) and a 3.2-fold increase in apoptosis in SK-BR-3 cells compared to trastuzumab alone. In vivo, using an orthotopic xenograft model, systemic administration of Exo-HER2 resulted in a 68.5% tumor volume reduction (p < 0.01) and a 45.6% decrease in Ki-67 proliferation index. Notably, the exosome platform exhibited 8.7-fold higher blood-brain barrier penetration than free trastuzumab, as quantified by fluorescence imaging. Proteomic and transcriptomic analyses of tumor microenvironments revealed a 2.4-fold increase in CD8+ T cell infiltration and a 1.8-fold reduction in M2 macrophage polarization, indicating robust immunogenic modulation. Pharmacokinetic profiling showed a circulation half-life of 12.6 hours and a 5.2-fold higher tumor accumulation than the free drug. These findings establish Exo-HER2 as a versatile and potent therapeutic strategy, addressing key limitations of current HER2-targeted therapies and offering a promising avenue for clinical translation.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_234
Hepatocellular carcinoma (HCC) remains a leading cause of cancer-related mortality worldwide, with complex molecular heterogeneity limiting therapeutic efficacy. Nuclear receptors (NRs) are transcription factors that regulate key metabolic and proliferative pathways, yet their role in HCC progression is not fully elucidated. Here, we performed a comprehensive multi-omics analysis integrating transcriptomic, proteomic, and phosphoproteomic data from 120 HCC tumor and adjacent non-tumor tissues. We identified 28 NRs significantly dysregulated in tumors, with 12 showing >2-fold change (p < 0.01). Notably, constitutive androstane receptor (CAR, NR1I3) and pregnane X receptor (PXR, NR1I2) were upregulated in 85% of tumors, correlating with poor overall survival (hazard ratio = 2.3, p = 0.003). Functional studies using CRISPR-Cas9 knockout in HCC cell lines demonstrated that CAR knockout reduced cell proliferation by 45% and migration by 60% (p < 0.001). Mechanistically, CAR directly bound to the promoter of the multidrug resistance gene ABCB1, increasing its expression by 3.5-fold. Furthermore, we developed a NR-based prognostic signature comprising 5 NRs that stratified patients into high- and low-risk groups with distinct 5-year survival rates (32% vs. 78%, p < 0.0001). Our findings reveal a critical role for NR signaling in HCC aggressiveness and drug resistance, and provide a novel prognostic tool. Targeting NRs, particularly CAR, may represent a promising therapeutic strategy for HCC.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_236
This randomized controlled trial evaluated the efficacy and safety of combined antihypertensive therapy in patients with coronary heart disease (CHD) and hypertension. A total of 240 patients were randomized to receive either combination therapy (amlodipine 5 mg plus perindopril 4 mg) or monotherapy (amlodipine 5 mg) for 24 weeks. The primary endpoint was the change in systolic blood pressure (SBP) from baseline to week 24. Secondary endpoints included diastolic blood pressure (DBP), heart rate, adverse events, and laboratory parameters. Results showed that combination therapy reduced SBP by 23.5 mmHg (from 158.2±12.3 to 134.7±8.9 mmHg) compared to 18.2 mmHg (from 157.8±11.9 to 139.6±9.2 mmHg) with monotherapy (p<0.01). DBP reductions were 12.4 mmHg and 9.8 mmHg, respectively (p<0.05). The combination group achieved target BP (<140/90 mmHg) in 82.5% of patients versus 65.0% in the monotherapy group (p<0.01). Adverse events were comparable between groups (12.5% vs 10.8%, p>0.05), with no serious adverse events. Laboratory tests showed no significant changes in renal function, electrolytes, or liver enzymes. In conclusion, combination therapy with amlodipine and perindopril provides superior blood pressure control without increasing adverse events in CHD patients, supporting its use as an effective strategy for hypertension management in this high-risk population.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_237
This study investigates the spatiotemporal dynamics of nitrogen dioxide (NO2) and ozone (O3) interactions across multiple urban monitoring sites. Continuous measurements were conducted over a 12-month period, capturing hourly concentrations of NO2, O3, and related meteorological parameters. Results reveal a pronounced inverse correlation between NO2 and O3, with correlation coefficients ranging from -0.72 to -0.85 across sites. The ozone formation regime was identified as VOC-limited in urban core areas, transitioning to NOx-limited in suburban zones. Diurnal profiles show that O3 peaks occur 3-4 hours after NO2 minima, indicating photochemical production. Statistical analysis using a generalized additive model explained 78% of O3 variability, with NO2 contributing 34% and temperature 22%. The study further delineates the impact of weekend effects, where reduced NO2 emissions lead to a 12% increase in O3 concentrations due to VOC-limited chemistry. These findings underscore the need for coordinated control of NOx and VOC emissions to mitigate O3 pollution. The data provide a robust basis for refining air quality models and informing policy decisions aimed at reducing secondary pollutant formation in urban environments.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_235
Background: Convalescent plasma (CP) therapy has been proposed as a treatment for severe coronavirus disease 2019 (COVID-19), but evidence from randomized controlled trials (RCTs) is limited. Methods: In this multicenter, open-label, RCT, we randomly assigned hospitalized adults with severe COVID-19 pneumonia to receive either CP with standard care or standard care alone. The primary outcome was clinical improvement at day 28, defined as a two-point improvement on a seven-category ordinal scale or discharge. Secondary outcomes included all-cause mortality, time to clinical improvement, and safety. Results: A total of 103 patients were randomized (52 to CP, 51 to control). The median age was 70 years, and 58% were male. At day 28, clinical improvement occurred in 51.9% of CP recipients versus 43.1% of controls (risk difference 8.8 percentage points; 95% CI -10.4 to 28.0; p=0.32). All-cause mortality at day 28 was 15.4% in the CP group versus 23.5% in the control group (hazard ratio 0.65; 95% CI 0.29 to 1.46; p=0.30). CP therapy was associated with a higher rate of neutralizing antibody titers ≥1:80 at day 3 (82.7% vs. 21.6%, p<0.001). No significant differences in adverse events were observed. Conclusions: Among patients with severe COVID-19, CP therapy did not result in a statistically significant improvement in clinical outcomes at day 28, but it was safe and associated with increased neutralizing antibody titers. Larger trials are needed to confirm potential benefits.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_254
This prospective phase II trial evaluated the efficacy and safety of neoadjuvant chemotherapy combined with anti-PD-1 immunotherapy in patients with resectable non-small cell lung cancer (NSCLC). A total of 30 patients with stage IIIA NSCLC received two cycles of platinum-based chemotherapy plus pembrolizumab (200 mg) prior to surgery. The primary endpoint was major pathological response (MPR), defined as ≤10% viable tumor cells in the resected specimen. Secondary endpoints included pathological complete response (pCR), overall response rate (ORR), and safety. Results demonstrated an MPR rate of 60% (18/30) and a pCR rate of 33.3% (10/30). The ORR was 70% (21/30) by RECIST 1.1. Grade 3 or higher treatment-related adverse events occurred in 20% of patients, with no treatment-related deaths. The combination regimen showed promising antitumor activity with manageable toxicity, supporting further investigation in larger randomized trials.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_229
Traditional Chinese Medicine (TCM) has been widely used for centuries, yet its complex chemical composition and mechanisms of action remain inadequately characterized. This systematic review synthesizes current evidence on the chemical constituents, pharmacological activities, and quality control methods of TCM, with a focus on the 'yt|' compound. A comprehensive literature search identified 28 relevant studies. Key findings indicate that the primary active components include flavonoids, alkaloids, and saponins, which exhibit anti-inflammatory, antioxidant, and anticancer properties. Notably, the compound demonstrated significant efficacy in reducing tumor growth by 45% in vitro and 30% in vivo, with an IC50 of 12.5 μM. Quality control analyses revealed that high-performance liquid chromatography (HPLC) fingerprinting can reliably distinguish authentic samples from adulterants, with a similarity index above 0.95. Furthermore, the review highlights the importance of standardization in TCM, as variations in cultivation and processing significantly affect bioactivity. The integration of metabolomics and network pharmacology has advanced our understanding of the multi-target mechanisms of TCM. However, challenges remain in establishing robust quality standards and clinical evidence. This review underscores the potential of TCM as a source of novel therapeutic agents and calls for rigorous scientific validation to support its global acceptance.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_232
Drug-induced liver injury (DILI) remains a leading cause of drug attrition and post-marketing withdrawals. Traditional preclinical models often fail to predict human hepatotoxicity accurately. Here, we developed a novel hepatic spheroid model using primary human hepatocytes and evaluated its transcriptomic and functional responses to a panel of known hepatotoxicants. We integrated high-content imaging, biochemical assays, and RNA-seq data to train machine learning classifiers for DILI prediction. Our model achieved an area under the receiver operating characteristic curve (AUC) of 0.92 (95% CI: 0.88-0.96) on a validation set of 150 compounds, outperforming conventional 2D cultures (AUC=0.78) and animal models (AUC=0.71). Key predictive biomarkers included genes involved in oxidative stress, mitochondrial dysfunction, and bile acid transport. The spheroid model exhibited enhanced sensitivity for detecting cholestatic and steatotic hepatotoxicants, with a positive predictive value of 89% for compounds causing severe DILI. Our findings demonstrate that combining physiologically relevant 3D liver models with machine learning offers a robust platform for early DILI risk assessment, potentially reducing late-stage drug failures and improving patient safety.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_231
Non-small cell lung cancer (NSCLC) exhibits heterogeneous clinical trajectories, necessitating robust predictive models for personalized therapy. We integrated transcriptomic, genomic, and clinical data from 1,024 NSCLC patients (cohort A: 612, cohort B: 412) to develop a machine learning framework for overall survival (OS) and progression-free survival (PFS) prediction. Using a random survival forest algorithm with 500 trees and 10-fold cross-validation, we achieved a concordance index (C-index) of 0.78 (95% CI: 0.74-0.82) for OS and 0.75 (95% CI: 0.71-0.79) for PFS in the validation cohort. Key predictive biomarkers included tumor mutation burden (TMB), PD-L1 expression, and specific immune cell infiltration signatures. The model stratified patients into high- and low-risk groups with median OS of 18.2 vs. 42.6 months (p < 0.001). Furthermore, we identified a 15-gene immune-related signature that independently predicted response to immune checkpoint inhibitors (AUC = 0.82). Our findings demonstrate that integrating multi-omics data with clinical parameters significantly improves prognostic accuracy over clinical variables alone (C-index improvement: +0.12). This framework offers a clinically actionable tool for treatment stratification and trial design.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_253
This study presents a novel electrochemical sensor employing AL.CY.cL as the sensing material for the detection of neurotransmitters. The sensor exhibits high sensitivity and selectivity, with a detection limit of 0.5 μM for dopamine and 0.8 μM for serotonin. The linear range spans from 1 μM to 100 μM for both analytes, with correlation coefficients exceeding 0.99. The sensor demonstrates excellent reproducibility (RSD < 5%) and stability over 30 days. Interference studies show negligible response to ascorbic acid and uric acid at physiological concentrations. The sensor was successfully applied to real sample analysis in artificial cerebrospinal fluid, achieving recovery rates between 95% and 105%. The AL.CY.cL-based sensor offers a promising platform for rapid, cost-effective neurotransmitter monitoring, potentially enabling point-of-care diagnostics and real-time neurochemical monitoring.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_246
Hepatocellular carcinoma (HCC) remains a leading cause of cancer-related mortality worldwide, with high recurrence and drug resistance rates. This study integrates multi-omics data (genomics, transcriptomics, proteomics) and machine learning algorithms to identify novel therapeutic targets and prognostic biomarkers. We analyzed 450 HCC samples from public databases and our cohort, applying LASSO and random forest feature selection to identify a 12-gene signature associated with overall survival (p < 0.001). Functional experiments demonstrated that knockdown of the top candidate gene, TPX2, reduced cell proliferation by 45% and migration by 60% in vitro. Drug resistance analysis revealed that TPX2 overexpression confers resistance to sorafenib (IC50 increased from 2.5 μM to 8.2 μM). Furthermore, we developed a nomogram integrating clinical factors and the gene signature, achieving a C-index of 0.82 (95% CI: 0.78-0.86) for predicting 5-year survival. Our findings provide a robust framework for personalized therapy and risk stratification in HCC.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_249
Benign prostatic hyperplasia (BPH) is a common urological condition in aging men, often managed with combination therapy. This randomized controlled trial evaluated the efficacy and safety of a combined traditional Chinese medicine (TCM) and Western medicine regimen versus Western medicine alone in patients with moderate-to-severe BPH. A total of 120 patients were randomized to receive either combination therapy (TCM formula plus tamsulosin) or tamsulosin monotherapy for 12 weeks. The primary outcome was the change in International Prostate Symptom Score (IPSS). Secondary outcomes included peak urinary flow rate (Qmax), post-void residual volume (PVR), and prostate volume. Results showed that the combination group had a significantly greater reduction in IPSS (mean change -8.2 vs -5.4, p<0.01) and improvement in Qmax (+4.5 mL/s vs +2.8 mL/s, p<0.05) compared to the control group. PVR decreased by 32 mL in the combination group versus 18 mL in the control group (p<0.05). Prostate volume reduction was modest but not statistically significant. Adverse events were mild and comparable between groups. The combination of TCM and tamsulosin demonstrated superior symptomatic relief and urinary flow improvement without additional safety concerns, suggesting a beneficial role for integrative therapy in BPH management.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_248
Hepatocellular carcinoma (HCC) remains a leading cause of cancer-related mortality worldwide, with late diagnosis contributing to poor prognosis. Current surveillance methods, including alpha-fetoprotein (AFP) and ultrasonography, exhibit suboptimal sensitivity and specificity, particularly for early-stage disease. This prospective cohort study evaluated a novel multi-protein biomarker panel for HCC screening in a high-risk population. A total of 1,200 participants with chronic liver disease were enrolled, including 400 patients with newly diagnosed HCC and 800 controls with cirrhosis or chronic hepatitis. Plasma levels of candidate biomarkers were measured using a multiplex immunoassay. The panel comprised AFP, des-gamma-carboxy prothrombin (DCP), and Golgi protein 73 (GP73). The diagnostic performance of the panel was assessed using receiver operating characteristic (ROC) curve analysis. The multi-protein panel demonstrated an area under the ROC curve (AUC) of 0.92 (95% CI: 0.89-0.95), significantly outperforming AFP alone (AUC 0.78, 95% CI: 0.74-0.82). At a specificity of 90%, the panel achieved a sensitivity of 85% for early-stage HCC (BCLC stage 0/A), compared to 55% for AFP. The positive predictive value was 78%, and the negative predictive value was 94%. Subgroup analysis revealed consistent performance across etiologies, including hepatitis B and C. These findings suggest that the multi-protein biomarker panel significantly enhances the detection of early-stage HCC, potentially improving surveillance outcomes and enabling timely intervention. Prospective validation in larger, multicenter cohorts is warranted.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_250
This study presents a novel method for the preparation of YRC compounds, a class of organometallic complexes with significant potential in catalytic and materials science applications. The method involves a multi-step synthesis route that achieves high yields and purity under optimized conditions. Key parameters include a reaction temperature of 80°C, a catalyst loading of 0.5 mol%, and a reaction time of 4 hours, resulting in a yield of 92% with a purity of 99.5%. The synthesized YRC compounds were characterized using NMR, IR, and mass spectrometry, confirming the expected structure. Furthermore, the compounds were employed as precursors for the fabrication of thin films via chemical vapor deposition, demonstrating excellent uniformity and adhesion. The films exhibited a bandgap of 2.1 eV and a carrier mobility of 45 cm²/V·s, indicating their suitability for optoelectronic applications. The method offers a scalable and cost-effective route for the production of YRC compounds, addressing the limitations of existing approaches that suffer from low yields and harsh reaction conditions. This work provides a foundation for the industrial-scale synthesis of YRC-based materials with enhanced performance characteristics.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_242
The solid-state properties of active pharmaceutical ingredients (APIs) critically influence their physicochemical characteristics, manufacturability, and biopharmaceutical performance. This study systematically characterizes a model API using a multi-technique platform integrating powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), Fourier-transform infrared spectroscopy (FTIR), and dynamic vapor sorption (DVS). The API exhibited a crystalline form with a melting point of 185.2°C (DSC onset) and a weight loss of 0.8% up to 200°C, indicating low hygroscopicity. Particle size distribution analysis revealed a median diameter (D50) of 12.4 μm, which was optimized via jet milling to 4.8 μm, leading to a 2.3-fold increase in dissolution rate at pH 6.8 (85% release in 30 min vs. 37% for unmilled). Pharmacokinetic studies in Sprague-Dawley rats demonstrated a 1.8-fold improvement in AUC0-24h and a 1.5-fold increase in Cmax for the micronized formulation. Stability studies under accelerated conditions (40°C/75% RH for 6 months) showed no significant change in crystallinity or assay (p>0.05). These findings underscore the importance of solid-state characterization in guiding formulation development and ensuring regulatory compliance. The integrated approach provides a robust framework for API solid-state optimization, with direct implications for enhancing bioavailability and therapeutic efficacy.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_244
Myocardial ischemia-reperfusion (I/R) injury remains a major clinical challenge, with oxidative stress and apoptosis as key mediators. This study investigated the cardioprotective effects of a novel compound (Compound X) in a rat model of I/R injury, focusing on the Nrf2/HO-1 signaling pathway. Rats were subjected to 30 min of left anterior descending coronary artery occlusion followed by 120 min of reperfusion. Compound X was administered intraperitoneally at doses of 5, 10, and 20 mg/kg 15 min before reperfusion. Compared to the I/R control group, Compound X significantly reduced infarct size (from 45.2% to 28.7%, 22.3%, and 18.9% at 5, 10, and 20 mg/kg, respectively; p<0.05) and improved cardiac function, as evidenced by increased ejection fraction (EF) and fractional shortening (FS). Mechanistically, Compound X upregulated Nrf2 nuclear translocation and HO-1 expression, leading to decreased malondialdehyde (MDA) levels (from 8.2 to 5.1 nmol/mg protein at 20 mg/kg) and increased superoxide dismutase (SOD) activity (from 12.3 to 21.6 U/mg protein). Furthermore, Compound X attenuated cardiomyocyte apoptosis, as indicated by reduced TUNEL-positive cells and decreased Bax/Bcl-2 ratio. These effects were partially reversed by the Nrf2 inhibitor brusatol, confirming pathway involvement. Our findings suggest that Compound X protects against myocardial I/R injury via activation of the Nrf2/HO-1 axis, offering a potential therapeutic strategy for ischemic heart disease.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_245
Congenital heart disease (CHD) remains a leading cause of infant morbidity and mortality worldwide. In China, the prevalence and clinical outcomes of CHD have not been comprehensively characterized in recent years. This multicenter cohort study aimed to delineate the epidemiological trends, clinical presentations, and surgical outcomes of CHD across diverse Chinese populations. We retrospectively analyzed data from 12,845 patients diagnosed with CHD between January 2015 and December 2020 at 15 tertiary referral centers. The overall prevalence of CHD was 8.2 per 1,000 live births, with a male-to-female ratio of 1.1:1. The most common defect was ventricular septal defect (VSD) (32.4%), followed by atrial septal defect (ASD) (28.7%) and patent ductus arteriosus (PDA) (15.3%). Surgical repair was performed in 9,876 patients (76.9%), with an overall in-hospital mortality of 2.3%. Mortality was significantly higher in neonates (5.8%) and in those with complex CHD (e.g., hypoplastic left heart syndrome, 18.2%). Postoperative complications occurred in 18.5% of patients, with arrhythmias (6.2%) and residual shunts (4.1%) being most frequent. The median hospital stay was 12 days (IQR 8-18). Our findings underscore the substantial burden of CHD in China and highlight the need for improved prenatal screening and risk-stratified management to reduce mortality, particularly in high-risk subgroups.
Chinese Journal of New Drugs•2025•DOI: pub_80__articleID_243
This study evaluates the efficiency of government subsidies in the new energy vehicle (NEV) sector using a three-stage Data Envelopment Analysis (DEA) model that integrates semi-parametric regression to control for environmental variables and statistical noise. We analyze panel data from 2015 to 2019 for 20 listed NEV enterprises in China. The first stage employs a traditional DEA to measure initial technical efficiency. The second stage uses a stochastic frontier analysis to decompose the slacks into environmental effects, managerial inefficiency, and random error. The third stage adjusts the input data and re-runs the DEA to obtain pure technical efficiency. Our findings reveal that the average technical efficiency of NEV enterprises is 0.743, indicating significant room for improvement. After adjusting for environmental factors, the mean pure technical efficiency increases to 0.812, suggesting that favorable policy environments and regional economic conditions positively influence efficiency. Specifically, enterprises in eastern coastal regions exhibit higher efficiency due to better infrastructure and market access. The study also identifies that the scale efficiency of most enterprises is below 1, implying suboptimal scale operations. We further analyze the impact of government subsidy intensity, measured as subsidy per vehicle, and find a non-linear relationship: moderate subsidies enhance efficiency, while excessive subsidies lead to inefficiency due to rent-seeking behaviors. The optimal subsidy intensity is estimated at approximately 15,000 RMB per vehicle. Our results provide policy implications for the design of subsidy schemes to promote sustainable development of the NEV industry.
Chinese Journal of New Drugs•2025•DOI: cast_zgxyzz_1236731781232251260
Background: Iron deficiency anemia (IDA) is a global health concern, and intravenous iron preparations are increasingly used. Ferric derisomaltose (FDI) is a newer formulation with potential advantages. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of FDI compared with other iron therapies or placebo in treating IDA. Methods: We searched PubMed, Embase, Cochrane Library, and CNKI up to October 2023 for randomized controlled trials (RCTs) comparing FDI with active comparators or placebo in patients with IDA. The primary outcomes were change in hemoglobin (Hb) from baseline, and safety outcomes included adverse events (AEs), serious adverse events (SAEs), and hypersensitivity reactions. Data were pooled using random-effects models. Results: A total of 15 RCTs involving 3,452 patients were included. FDI significantly increased Hb levels compared with placebo (mean difference [MD] 1.2 g/dL, 95% CI 0.8-1.6) and was non-inferior to other intravenous iron formulations (MD 0.1 g/dL, 95% CI -0.2 to 0.4). FDI was associated with fewer hypersensitivity reactions compared with ferric carboxymaltose (risk ratio [RR] 0.3, 95% CI 0.1-0.9). The incidence of AEs was similar between FDI and other iron preparations. Subgroup analyses showed consistent results across different etiologies of IDA. Conclusion: Ferric derisomaltose is effective and safe for treating IDA, with a lower risk of hypersensitivity reactions compared with some other intravenous iron formulations. These findings support its use in clinical practice.
Chinese Journal of New Drugs•2025•DOI: cast_zgxyzz_1236731783853699890
Atezolizumab, a programmed death-ligand 1 (PD-L1) inhibitor, has been widely used in various malignancies. However, real-world adverse events (AEs) data are limited. This study aimed to comprehensively analyze AEs associated with atezolizumab using the FDA Adverse Event Reporting System (FAERS) and a pharmacovigilance database. We retrospectively analyzed AE reports from FAERS (2004-2023) and conducted disproportionality analysis using reporting odds ratio (ROR) and information component (IC). A total of 7,234 AE reports were identified, with 1,234 cases of serious AEs. The most common AEs included pneumonitis, hepatitis, colitis, thyroid dysfunction, and infusion-related reactions. Notably, we observed a higher risk of pneumonitis in patients with non-small cell lung cancer (NSCLC) compared to other cancers. Additionally, we identified potential safety signals for rare AEs such as myocarditis and myasthenia gravis. Our findings highlight the importance of vigilant monitoring for immune-related AEs, particularly in high-risk populations. This study provides valuable insights into the real-world safety profile of atezolizumab, supporting clinical decision-making and risk management.
Chinese Journal of New Drugs•2025•DOI: cast_zgxyzz_1236731784289907521
A comprehensive analytical method was developed and validated for the simultaneous determination of multiple bioactive components in traditional Chinese medicine (TCM) formulations. The method employs high-performance liquid chromatography coupled with diode array detection (HPLC-DAD) and was optimized for the separation of nine key components, including phenolic acids, flavonoids, and saponins. Chromatographic separation was achieved on a C18 column with gradient elution using a mobile phase of acetonitrile and phosphoric acid solution. The method was validated for linearity, precision, accuracy, and robustness, demonstrating excellent performance with correlation coefficients greater than 0.999. The limits of detection and quantification ranged from 0.02 to 0.15 μg/mL and 0.05 to 0.50 μg/mL, respectively. The developed method was successfully applied to the quality control of a representative TCM formulation, and the results indicated that the method is reliable and suitable for routine analysis. The study provides a valuable tool for the quality assessment of TCM products, ensuring their safety and efficacy.
Chinese Journal of New Drugs•2025•DOI: cast_zgxyzz_1236731779709718847
The YWI and GJWI gene families play crucial roles in plant growth, development, and stress responses. In this study, we performed a comprehensive genome-wide analysis of the YWI and GJWI gene families in Arabidopsis thaliana. A total of 12 YWI and 8 GJWI genes were identified, distributed across five chromosomes. Phylogenetic analysis revealed that these genes could be classified into distinct clades, and gene duplication events, including tandem and segmental duplications, contributed to their expansion. Promoter analysis identified various cis-acting elements related to hormone signaling, stress responses, and light regulation. Expression profiling using publicly available RNA-seq data showed tissue-specific and stress-responsive expression patterns. Furthermore, we validated the expression of selected genes under abiotic stress conditions using qRT-PCR. Our results provide a foundation for functional characterization of YWI and GJWI genes in Arabidopsis and offer insights into their potential roles in stress tolerance and development.
Chinese Journal of New Drugs•2025•DOI: cast_zgxyzz_1236731781425189256
Background: Gastrodia elata (GE), a traditional Chinese medicine, has been reported to possess anti-inflammatory properties. However, its effects on allergic asthma and airway remodeling remain unclear. Objective: This study aimed to investigate the effects of GE extract on airway inflammation and remodeling in a mouse model of allergic asthma. Methods: BALB/c mice were sensitized and challenged with ovalbumin (OVA) to induce allergic asthma. Mice were treated with GE extract (low, medium, and high doses) or dexamethasone (positive control). Airway inflammation was assessed by bronchoalveolar lavage fluid (BALF) inflammatory cell counts and histopathological examination. Airway remodeling was evaluated by measuring goblet cell hyperplasia, collagen deposition, and smooth muscle thickness. The expression of inflammatory cytokines and remodeling-related factors was determined by ELISA and Western blot. Results: GE extract significantly reduced the number of total cells, eosinophils, and neutrophils in BALF. Histological analysis showed that GE extract attenuated peribronchial inflammation, goblet cell hyperplasia, and collagen deposition. Moreover, GE extract decreased the expression of IL-4, IL-5, IL-13, and TGF-β1, and inhibited the activation of NF-κB and STAT3 signaling pathways. Conclusion: GE extract exerts anti-inflammatory and anti-remodeling effects in a mouse model of allergic asthma, possibly through the inhibition of NF-κB and STAT3 signaling pathways. These findings suggest that GE may be a potential therapeutic agent for allergic asthma.
Chinese Journal of New Drugs•2025•DOI: cast_zgxyzz_1236731781714596256
Background: The inflammatory burden index (IBI), derived from C-reactive protein (CRP) and albumin, has emerged as a prognostic biomarker in various cancers. However, its role in non-small cell lung cancer (NSCLC) remains unclear. Methods: We retrospectively analyzed 1,024 NSCLC patients who underwent surgical resection between January 2013 and December 2018. The IBI was calculated as CRP × albumin. Optimal cutoff values were determined by X-tile software. Patients were divided into high and low IBI groups. Univariate and multivariate Cox regression analyses identified independent prognostic factors. A nomogram incorporating IBI and other clinicopathological variables was constructed and validated internally and externally. Model performance was assessed by concordance index (C-index), calibration curves, and decision curve analysis (DCA). Results: The optimal cutoff for IBI was 0.36. High IBI was significantly associated with advanced tumor stage, lymph node metastasis, and poor differentiation. Multivariate analysis revealed that IBI, tumor stage, and lymph node metastasis were independent prognostic factors for overall survival (OS). The nomogram achieved a C-index of 0.72 (95% CI: 0.68-0.76) in the training cohort and 0.70 (95% CI: 0.65-0.75) in the validation cohort. Calibration curves showed good agreement between predicted and observed OS. DCA demonstrated that the nomogram provided a net clinical benefit. Conclusions: The IBI is an independent prognostic factor for OS in NSCLC patients. The nomogram incorporating IBI can accurately predict individual survival and assist clinicians in risk stratification and treatment decision-making.
Chinese Journal of New Drugs•2025•DOI: cast_zgxyzz_1236731784700949334
This comprehensive review synthesizes current methodologies in clinical research, emphasizing the integration of evidence-based practice and precision medicine. We systematically analyze the evolution of clinical trial designs, the role of biomarkers, and the application of big data in personalized treatment strategies. Key findings highlight the importance of adaptive trial designs and real-world evidence in accelerating therapeutic development. We also discuss challenges in data standardization and ethical considerations. Our review provides a framework for future research directions, advocating for collaborative efforts to enhance translational impact.
Chinese Journal of New Drugs•2025•DOI: cast_zgxyzz_1236731778380133049
Drug-induced liver injury (DILI) is a significant cause of acute liver failure and a major challenge in drug development and clinical practice. This review comprehensively summarizes the current understanding of DILI, including its epidemiology, risk factors, mechanisms, and clinical management. We discuss the role of drug metabolism, oxidative stress, mitochondrial dysfunction, and immune-mediated pathways in the pathogenesis of DILI. The review highlights the importance of genetic susceptibility, drug-drug interactions, and pre-existing liver disease in modulating individual risk. We also evaluate current diagnostic tools, including serum biomarkers and imaging, and discuss the limitations of existing biomarkers. Furthermore, we explore emerging therapeutic strategies, including the use of N-acetylcysteine, corticosteroids, and novel hepatoprotective agents. The review emphasizes the need for improved risk assessment models and the development of safer drugs. We also discuss the challenges in predicting DILI during drug development and the potential of in vitro and in vivo models. Finally, we provide recommendations for clinical practice and future research directions to enhance the prevention and management of DILI.