Glatard Anaïs, Bourguignon Laurent, Jelliffe Roger W, Maire Pascal, Neely Michael N, Goutelle Sylvain
Service pharmaceutique-ADCAPT, Groupement Hospitalier de Gériatrie, Hospices Civils de Lyon, Lyon, France.
Service pharmaceutique-ADCAPT, Groupement Hospitalier de Gériatrie, Hospices Civils de Lyon, Lyon, France Laboratoire de Biométrie et Biologie Evolutive, CNRS UMR 5558, Université Lyon 1, Villeurbanne, France.
Antimicrob Agents Chemother. 2015;59(6):2986-94. doi: 10.1128/AAC.04132-14. Epub 2015 Mar 9.
Vancomycin is a renally excreted drug, and its body clearance correlates with creatinine clearance. However, the renal function estimation equation that best predicts vancomycin clearance has not been established yet. The objective of this study was to compare the abilities of different renal function estimation equations to describe vancomycin pharmacokinetics in elderly patients. The NPAG algorithm was used to perform population pharmacokinetic analysis of vancomycin concentrations in 78 elderly patients. Six pharmacokinetic models of vancomycin clearance were built, based on the following equations: Cockcroft-Gault (CG), Jelliffe (JEL), Modification of Diet in Renal Disease (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (both in milliliters per minute per 1.73 m(2)), and modified MDRD and CKD-EPI equations (both in milliliters per minute). Goodness-of-fit and predictive performances of the six PK models were compared in a learning set (58 subjects) and a validation set (20 patients). Final analysis was performed to estimate population parameters in the entire population. In the learning step, the MDRD-based model best described the data, but the CG- and JEL-based models were the least biased. The mean weighted errors of prediction were significantly different between the six models (P = 0.0071). In the validation group, predictive performances were not significantly different. However, the use of a renal function estimation equation different from that used in the model building could significantly alter predictive performance. The final analysis showed important differences in parameter distributions and AUC estimation across the six models. This study shows that methods used to estimate renal function should not be considered interchangeable for pharmacokinetic modeling and model-based estimation of vancomycin concentrations in elderly patients.
万古霉素是一种经肾脏排泄的药物,其体内清除率与肌酐清除率相关。然而,目前尚未确定最能预测万古霉素清除率的肾功能评估方程。本研究的目的是比较不同肾功能评估方程描述老年患者万古霉素药代动力学的能力。采用非线性混合效应模型(NPAG)算法对78例老年患者的万古霉素血药浓度进行群体药代动力学分析。基于以下方程建立了六种万古霉素清除率的药代动力学模型:Cockcroft-Gault(CG)方程、Jelliffe(JEL)方程、肾脏病饮食改良(MDRD)方程、慢性肾脏病流行病学协作组(CKD-EPI)方程(均以每分钟每1.73平方米的毫升数表示),以及改良的MDRD方程和CKD-EPI方程(均以每分钟的毫升数表示)。在一个学习集(58名受试者)和一个验证集(20名患者)中比较了这六种药代动力学模型的拟合优度和预测性能。进行最终分析以估计整个人群的群体参数。在学习步骤中,基于MDRD方程的模型对数据的描述最佳,但基于CG方程和JEL方程的模型偏差最小。六种模型的平均加权预测误差有显著差异(P = 0.0071)。在验证组中,预测性能无显著差异。然而,使用与模型构建中不同的肾功能评估方程会显著改变预测性能。最终分析表明,六种模型在参数分布和AUC估计方面存在重要差异。本研究表明,在老年患者的药代动力学建模和基于模型的万古霉素浓度估计中,用于估计肾功能的方法不应被视为可相互替代的。