基于峰浓度和谷浓度的两点法预测万古霉素 AUC 的临床验证。
Clinical validation of the two-point method for predicting vancomycin AUC based on peak and trough plasma concentrations.
机构信息
Department of Intensive Medicine, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No. 134 Dongjie Road, Fuzhou, 350001, Fujian, China.
Medical College of Fujian Medical University, Fuzhou, 350001, Fujian, China.
出版信息
Int J Clin Pharm. 2022 Dec;44(6):1325-1331. doi: 10.1007/s11096-022-01474-9. Epub 2022 Sep 22.
BACKGROUND
Vancomycin area under the curve/minimum inhibitory concentration (AUC/MIC) has been proposed as a therapeutic drug monitoring (TDM) target to dose vancomycin. It is time-consuming to estimate AUCs using traditional methods. A two-point trough-peak method is more straightforward for calculating the vancomycin AUC. However, the technique and the AUC/MIC target have not been validated in Chinese patients.
AIM
To compare the clinical outcomes of vancomycin therapy in Chinese older adults (aged > 60 years) between the trough-only and the two-point peak-trough AUC TDM approaches.
METHOD
The patients were divided into study and control groups according to TDM approaches. A trough-based TDM was used in the control group (target trough level 15-20 mg/L). Stanford University has provided a method to predict vancomycin AUC using peak-valley concentration alone (two-point method). A two-point trough-peak TDM approach was employed in the study group (target AUC/MIC ≥ 400). The effect of vancomycin was evaluated in terms of clinical findings, laboratory values, and bacteriologic responses. The effects of treatment and kidney functions were compared between the two groups.
RESULTS
A total of 389 patients met the study inclusion criteria, and 189 were excluded based on the exclusion criteria. Of the 200 patients, 80 received the two-point TDM approach (the study group), and 120 were monitored using the trough-based approach (the control group). The average age was 69.8 ± 7.1 years. Staphylococcus aureus (34%) was the most common Gram-positive bacteria. No vancomycin-related nephrotoxicity was observed in either group. The percentages of patients with an excellent response to vancomycin therapy were significantly higher in the study group than in the control group, 90% (72/80) versus 73.3% (88/120), P = 0.0039.
CONCLUSION
The two-point peak-trough method is practical for obtaining vancomycin AUC. The AUC/MIC ≥ 400 target demonstrates treatment effectiveness and safety in older Chinese patients.
背景
已提出万古霉素药时曲线下面积/最低抑菌浓度（AUC/MIC）作为万古霉素治疗药物监测（TDM）的目标，以确定万古霉素剂量。使用传统方法估计 AUC 较为耗时。两点谷峰浓度法更直接地计算万古霉素 AUC。然而，该技术和 AUC/MIC 目标尚未在中国患者中得到验证。
目的
比较两种 TDM 方法（仅谷值法和两点峰谷值 AUC TDM 法）在中国老年患者（年龄＞60 岁）万古霉素治疗中的临床结局。
方法
根据 TDM 方法将患者分为研究组和对照组。对照组采用谷值法（目标谷值 15-20mg/L）。斯坦福大学提供了一种单独使用峰谷浓度预测万古霉素 AUC 的方法（两点法）。研究组采用两点谷峰值 TDM 方法（目标 AUC/MIC≥400）。根据临床发现、实验室值和细菌学反应评估万古霉素的疗效。比较两组治疗和肾功能的效果。
结果
共有 389 例患者符合研究纳入标准，根据排除标准排除了 189 例。200 例患者中，80 例接受了两点 TDM 方法（研究组），120 例采用谷值法监测（对照组）。平均年龄为 69.8±7.1 岁。金黄色葡萄球菌（34%）是最常见的革兰阳性菌。两组均未观察到万古霉素相关肾毒性。研究组患者对万古霉素治疗的反应良好的比例明显高于对照组，90%（72/80）vs 73.3%（88/120），P=0.0039。
结论
两点峰谷浓度法实用，可获得万古霉素 AUC。AUC/MIC≥400 目标在中国老年患者中显示出治疗的有效性和安全性。
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