BACKGROUND The vancomycin trough level (VTL) is the most widely used pharmacokinetic parameter for monitoring its clinical efficacy. Whether the VTL is affected in patients receiving different vancomycin products has not previously been determined. METHODS From 2005 to 2015, five vancomycin products, including the innovator (designated as VAN-Lilly) and four generic versions (designated as VAN-A, VAN-B, VAN-C and VAN-D), were sequentially used in a teaching hospital. The initial VTLs were compared between patients who received different vancomycin products after propensity score (PS) weighting and matching for clinical covariates. RESULTS Among 8735 patients with initial VTL levels available for analysis, a significant association was identified between the VTL and different vancomycin products in children aged 1 month to 12 years (P < 0.0001). The PS weighting analysis in the paediatric group disclosed children on VAN-C had higher VTL compared to those on other four products (P = 0.0008). PS matching analysis revealed that children who received VAN-C had significantly higher VTLs than those who received VAN-Lily (P = 0.0001), VAN-A (P = 0.0008), VAN-B (P = 0.0002) or VAN-D (P = 0.0015). Furthermore, the coefficient of variation of the VTL was much greater in patients who received VAN-C than in those who received the other four versions, suggesting an unstable quality of this product. CONCLUSION A generic version of vancomycin generated significantly higher concentrations and greater variation of VTLs than the innovator and other generic vancomycin products in children. The VTL can serve as an indicator to monitor the quality of vancomycin products after marketing.

中文翻译：

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血清谷水平可作为通用万古霉素产品上市后质量的衡量标准。

背景技术万古霉素谷水平（VTL）是用于监测其临床疗效的最广泛使用的药代动力学参数。先前尚未确定接受不同万古霉素产品的患者中VTL是否受到影响。方法从2005年到2015年，在教学中依次使用了五种万古霉素产品，包括创新药（指定为VAN-Lilly）和四种通用版本（指定为VAN-A，VAN-B，VAN-C和VAN-D）。医院。在倾向评分（PS）加权并匹配临床协变量后，比较接受不同万古霉素产品的患者之间的初始VTL。结果在8735例初始VTL水平可分析的患者中，发现1个月至12岁儿童的VTL与不同的万古霉素产品之间存在显着相关性（P <0。0001）。小儿组的PS加权分析显示，与其他四种产品相比，使用VAN-C的儿童具有更高的VTL（P = 0.0008）。PS匹配分析显示，接受VAN-C的儿童的VTL明显高于接受VAN-Lily（P = 0.0001），VAN-A（P = 0.0008），VAN-B（P = 0.0002）或VAN-D（ P = 0.0015）。此外，接受VAN-C的患者的VTL变异系数比接受其他四种药物的患者大得多，这表明该产品的质量不稳定。结论与儿童创新药和其他通用万古霉素产品相比，通用型万古霉素产生的VTL浓度明显更高，变异性更大。VTL可以作为市场营销后监测万古霉素产品质量的指标。小儿组的PS加权分析显示，与其他四种产品相比，使用VAN-C的儿童具有更高的VTL（P = 0.0008）。PS匹配分析显示，接受VAN-C的儿童的VTL明显高于接受VAN-Lily（P = 0.0001），VAN-A（P = 0.0008），VAN-B（P = 0.0002）或VAN-D（ P = 0.0015）。此外，接受VAN-C的患者的VTL变异系数比接受其他四种药物的患者大得多，这表明该产品的质量不稳定。结论与儿童创新药和其他通用万古霉素产品相比，通用型万古霉素产生的VTL浓度明显更高，变异性更大。VTL可以作为市场营销后监测万古霉素产品质量的指标。小儿组的PS加权分析显示，与其他四种产品相比，使用VAN-C的儿童具有更高的VTL（P = 0.0008）。PS匹配分析显示，接受VAN-C的儿童的VTL明显高于接受VAN-Lily（P = 0.0001），VAN-A（P = 0.0008），VAN-B（P = 0.0002）或VAN-D（ P = 0.0015）。此外，接受VAN-C的患者的VTL变异系数比接受其他四种药物的患者大得多，这表明该产品的质量不稳定。结论与儿童创新药和其他通用万古霉素产品相比，通用型万古霉素产生的VTL浓度明显更高，变异性更大。VTL可以作为市场营销后监测万古霉素产品质量的指标。