新型网络应用程序对万古霉素有限采样浓度时间曲线下面积估算性能的评估。
Performance of Area under the Concentration-Time Curve Estimations of Vancomycin with Limited Sampling by a Newly Developed Web Application.
机构信息
Department of Pharmacy, Kumamoto University Hospital, 1-1-1, Honjo, Chuo-ku, Kumamoto-shi, Kumamoto, 860-8556, Japan.
Department of Infection Control, Kumamoto University Hospital, 1-1-1, Honjo, Chuo-ku, Kumamoto-shi, Kumamoto, 860-8556, Japan.
出版信息
Pharm Res. 2021 Apr;38(4):637-646. doi: 10.1007/s11095-021-03030-y. Epub 2021 Mar 29.
PURPOSE
Therapeutic drug monitoring guided by the area under the concentration-time curve (AUC-guided TDM) is recommended for vancomycin. However, validated efficient software remains elusive to popularize AUC-guided TDM in Japan. The aim of this study was to validate a newly developed web application, PAT, for AUC estimation.
METHODS
PAT was developed on the R ver. 3.6.2 platform for use with mobile phones and personal computers. AUC estimated by PAT (AUC) was evaluated against the reference AUC (AUC) calculated with the log-linear trapezoidal rule using eight measured concentrations, or against AUC (AUC) calculated using an evaluated available software with clinical data.
RESULTS
Investigating the best sampling points with limited sampling, PAT produced the least bias using two concentrations at 1 h and 11 h after the end of infusion (slope 1.18, intercept -15.57, median AUC/AUC 0.93 [range 0.81-1.24]), where only one estimation (6%) was out of the predetermined acceptable range of 0.8-1.2. Employment of only a trough concentration was more biased (AUC/AUC range 0.73-1.30 for 11 h, AUC/AUC range 0.62-1.40 for 23 h). In comparison with the evaluated software, AUC was not biased against the AUC (slope 1.04, intercept -15.80, median AUC/AUC 1.00 [range 0.86-1.10]).
CONCLUSIONS
The new application using two concentrations was appropriately validated and might be efficient in popularizing the AUC-guided TDM of vancomycin.
目的
监测治疗药物浓度-时间曲线下面积（AUC）指导下的万古霉素治疗药物监测是推荐的。然而，在日本，仍缺乏有效的验证软件来推广 AUC 指导的 TDM。本研究的目的是验证一种新开发的网络应用程序 PAT，用于 AUC 估计。
方法
PAT 是在 R 版本 3.6.2 平台上开发的，可用于手机和个人电脑。使用 PAT 估计的 AUC（AUC）与使用对数线性梯形规则计算的参考 AUC（AUC）进行比较（使用 8 个测量浓度），或与使用临床数据评估的可用软件计算的 AUC（AUC）进行比较。
结果
在有限采样中，通过最佳采样点调查，PAT 在输注结束后 1 小时和 11 小时使用两个浓度时产生的偏差最小（斜率 1.18，截距-15.57，中位数 AUC/AUC 0.93 [范围 0.81-1.24]），只有一个估计值（6%）超出了预定的可接受范围 0.8-1.2。仅使用谷浓度时，偏差更大（11 小时时 AUC/AUC 范围为 0.73-1.30，23 小时时 AUC/AUC 范围为 0.62-1.40）。与评估软件相比，AUC 对 AUC 没有偏差（斜率 1.04，截距-15.80，中位数 AUC/AUC 1.00 [范围 0.86-1.10]）。
结论
使用两个浓度的新应用程序得到了适当的验证，可能有助于推广万古霉素的 AUC 指导 TDM。
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