Department of Clinical Pharmacy, Institute of Pharmacy, University of Hamburg, Hamburg, Germany.
CPT Pharmacometrics Syst Pharmacol. 2022 Jun;11(6):711-720. doi: 10.1002/psp4.12782. Epub 2022 Apr 5.
Vancomycin dosing should be accompanied by area under the concentration-time curve (AUC)-guided dosing using model-informed precision dosing software according to the latest guidelines. Although a peak plus a trough sample is considered the gold standard to determine the AUC, single-sample strategies might be more economic. Yet, optimal sampling times for AUC determination of vancomycin have not been systematically evaluated. In the present study, automated one- or two-sample strategies were systematically explored to estimate the AUC with a model averaging and a model selection algorithm. Both were compared with a conventional equation-based approach in a simulation-estimation study mimicking a heterogenous patient population (n = 6000). The optimal single-sample timepoints were identified between 2-6.5 h post dose, with varying bias values between -2.9% and 1.0% and an imprecision of 23.3%-24.0% across the population pharmacokinetic approaches. Adding a second sample between 4.5-6.0 h improved the predictive performance (-1.7% to 0.0% bias, 17.6%-18.6% imprecision), although the difference in the two-sampling strategies were minor. The equation-based approach was always positively biased and hence inferior to the population pharmacokinetic approaches. In conclusion, the approaches always preferred samples to be drawn early in the profile (<6.5 h), whereas sampling of trough concentrations resulted in a higher imprecision. Furthermore, optimal sampling during the early treatment phase could already give sufficient time to individualize the second dose, which is likely unfeasible using trough sampling.
万古霉素的剂量应根据最新指南,使用基于模型的精准剂量软件,通过浓度-时间曲线下面积(AUC)指导给药。虽然峰浓度加谷浓度被认为是确定 AUC 的金标准,但单样本策略可能更经济。然而,万古霉素 AUC 测定的最佳采样时间尚未得到系统评估。在本研究中,使用模型平均和模型选择算法,系统地探索了自动化的单样本或双样本策略,以估算 AUC。在模拟异质患者人群(n = 6000)的模拟-估计研究中,将这两种方法与传统的基于方程的方法进行了比较。最佳的单样本时间点介于给药后 2-6.5 小时之间,在整个人群药代动力学方法中,偏差值在-2.9%至 1.0%之间,不精密度在 23.3%-24.0%之间。在 4.5-6.0 小时之间添加第二个样本可改善预测性能(-1.7%至 0.0%偏差,17.6%-18.6%不精密度),尽管两种采样策略之间的差异较小。基于方程的方法总是存在正偏差,因此劣于人群药代动力学方法。总之,这些方法总是倾向于在早期(<6.5 小时)采集样本,而谷浓度采样则导致更高的不精密度。此外,在早期治疗阶段进行最佳采样可以为个体化第二剂量提供足够的时间,而使用谷浓度采样可能无法实现。