Key Takeaways & Executive Findings
- •• First large-sample application of UPLC-MS/MS for vancomycin therapeutic drug monitoring in orthopedic infection patients, with superior methodological performance compared to traditional immunoassays. • Identified the optimal therapeutic range of vancomycin (10-20 μg/mL) for orthopedic infection patients, providing evidence-based guidance for individualized dosing. • Demonstrated that vancomycin trough concentrations >20 μg/mL significantly increase the incidence of renal impairment, emphasizing the importance of therapeutic drug monitoring in ensuring medication safety. • Explored the potential impact of organic cation transporter 2 and multidrug resistance gene 1 polymorphisms on vancomycin pharmacokinetics, offering new insights for precision medicine.
Abstract
BACKGROUND: Vancomycin is widely used as a first-line drug for treating methicillin-resistant Staphylococcus aureus infections in orthopedic perioperative infection prevention and treatment. However, its narrow therapeutic window and large individual differences make blood drug concentration monitoring crucial for ensuring efficacy and safety. OBJECTIVE: To establish the ultra-performance liquid chromatography-tandem mass spectrometry method to determine the concentration of vancomycin in plasma, and explore the correlation of blood drug concentration changes with clinical efficacy and acute renal impairment. METHODS: Totally 200 orthopedic patients with bone infection who were hospitalized in Beijing Jishuitan Hospital Guizhou Hospital from January 2020 to May 2022 were selected. Blood drug concentration was measured by ultra-performance liquid chromatography-tandem mass spectrometry. Renal function indexes (blood creatinine and urea nitrogen) were monitored, and the clinical efficacy and acute renal impairment were analyzed in patients with different vancomycin blood concentration levels. RESULTS AND CONCLUSION: (1) The established UPLC-MS/MS method had a linear range of 0.5-120.0 μg/mL (R²=0.997), intra-day relative standard deviation of 4.82%-6.57%, inter-day relative standard deviation of 10.2%-12.3%, and accuracy of 97.3%-106%. (2) The clinical effective rate in the 10-20 μg/mL group (82%) was significantly higher than that in the <10 μg/mL group (67%) (P < 0.05). (3) The incidence of renal impairment in the >20 μg/mL group (35.0%) was significantly higher than that in the 10-20 μg/mL group (16.0%) and <10 μg/mL group (6.7%) (P < 0.05). (4) The established UPLC-MS/MS method is sensitive and accurate, and can be used for clinical monitoring of vancomycin blood concentration. Maintaining vancomycin blood concentration within 10-20 μg/mL can achieve the best clinical efficacy and reduce the risk of nephrotoxicity. Blood concentration monitoring is of great significance for guiding individualized administration.
1. Introduction
Vancomycin is an important glycopeptide antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) and other Gram-positive bacterial infections [1]. In the orthopedic field, vancomycin is mainly used for perioperative prophylaxis and treatment, including prophylactic use in high-risk patients for MRSA in type I (clean) incision surgery, therapeutic use in type II-IV incision surgery, and treatment of severe orthopedic infections such as osteomyelitis, periprosthetic joint infection, and surgical site infection [2]. In domestic orthopedic surgical site infections, the detection rate of MRSA can reach 30%-50% [3], making the application of vancomycin particularly important in orthopedics. However, vancomycin has a narrow therapeutic window and large individual differences. Inappropriate use can not only lead to treatment failure and the emergence of resistant strains, but also increase adverse reactions such as nephrotoxicity [4]. Studies have shown that vancomycin trough concentrations <10 μg/mL increase the risk of inducing resistance, while trough concentrations >20 μg/mL significantly increase the incidence of renal damage [5]. Therefore, how to rapidly and accurately monitor vancomycin blood concentration and individually adjust dosing regimens has become an urgent clinical problem.
Existing methods for vancomycin blood concentration detection mainly include immunoassay and high-performance liquid chromatography (HPLC). However, immunoassay is susceptible to cross-reaction, resulting in poor specificity; traditional HPLC, although accurate, has cumbersome pretreatment and relatively long analysis time [6]. In recent years, ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) has been widely used in therapeutic drug monitoring due to its high sensitivity, good selectivity, and fast analysis speed [7]. Furthermore, with the advancement of pharmacogenomics research, the potential impact of genetic polymorphisms on vancomycin pharmacokinetics has attracted increasing attention, providing new ideas for individualized therapy.
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WANG Shi-li, LUO Yuan, QIAO Li, YANG Yong-hong, ZHANG Yu-jie, ZHANG Shun (2026). Determination of vancomycin blood concentration and its relationship with safety in patients with orthopedic infection by ultra-performance liquid chromatography-tandem mass spectrometry. Chinese Journal of Tissue Engineering Research. https://doi.org/10.12307/2026.21405
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Frequently Asked Questions
What is the optimal vancomycin trough concentration for orthopedic infection patients?
The study found that maintaining vancomycin trough concentration within 10-20 μg/mL achieves the best clinical efficacy and reduces the risk of nephrotoxicity. Concentrations below 10 μg/mL increase the risk of resistance, while concentrations above 20 μg/mL significantly increase the incidence of renal impairment.
How was vancomycin blood concentration measured in this study?
Vancomycin blood concentration was measured using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), a method that offers high sensitivity, selectivity, and rapid analysis. The established method had a linear range of 0.5-120.0 μg/mL with good accuracy and precision.
What are the advantages of UPLC-MS/MS over traditional immunoassay methods?
UPLC-MS/MS provides higher specificity and sensitivity compared to immunoassays, which are prone to cross-reactivity. It also offers faster analysis times and better accuracy, making it more suitable for therapeutic drug monitoring of vancomycin.
Why is therapeutic drug monitoring important for vancomycin?
Vancomycin has a narrow therapeutic window and significant inter-individual variability. Monitoring blood concentrations helps ensure efficacy while minimizing the risk of nephrotoxicity and the development of resistance. This study emphasizes that maintaining concentrations within the optimal range is crucial for patient safety and treatment success.
What is the clinical significance of this study?
This study provides evidence-based guidance for individualized vancomycin dosing in orthopedic infection patients. By establishing a reliable UPLC-MS/MS method and identifying the optimal therapeutic range, it supports the routine use of therapeutic drug monitoring to improve clinical outcomes and reduce adverse effects.
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