群体药动学研究方法及其研究进展  

Population Pharmacokinetic Research Method and its Research Progress

作　　者：何春远 沈炳香[1] 谢海棠[2] HE Chunyuan;SHEN Bingxiang;XIE Haitang(Dept.of Pharmacy,People’s Hospital of Lu’an City,Anhui Lu’an 237005,China;Dept.of Clinical Pharmacy,Yijishan Hospital of Wannan Medical College,Anhui Wuhui 241002,China)

机构地区：[1]六安市人民医院药学部,安徽六安237005 [2]皖南医学院附属弋矶山医院临床药学部,安徽芜湖241002

出　　处：《中国医院用药评价与分析》2020年第12期1532-1536,共5页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：自1998年美国食品药品管理局批准群体分析的方法应用于存在特殊生理病理受试对象的新药临床试验药动学、药效学评价,并于1999年发布《群体药代动力学研究技术指导原则》以来,群体药动学(population pharmacokinetics,PPK)在药学中的研究越来越广泛。本文就PPK的基本原理、研究方法及进展进行简要概述,并着重阐述目前作为PPK分析“金标准”的非线性混合效应模型(nonlinear mixed effects modelling,NONMEN)法。PPK的研究方法对临床合理用药、新药研究及评价有很大的指导意义。相较于传统药动学研究方法,PPK能够更方便地解释各种因素造成的变异,为临床个体化用药提供重要参考。Since the US Food and Drug Administration approved the method of population analysis to be applied to the pharmacokinetic and pharmacodynamic evaluation of new drug clinical trials with special physiological and pathological subjects in 1998,and the“Guiding Principles for Population Pharmacokinetic Research Technology”was issued in 1999,population pharmacokinetics(PPK)has been widely studied in pharmacy.This article has briefly summarized the basic principle,research method and progress of PPK,and focuses on the nonlinear mixed effects modelling(NONMEN)method,which is currently“the gold standard”for PPK analysis.The research method of PPK has great guiding significance for clinical rational medication,research and evaluation of new drugs.Compared with traditional pharmacokinetic research methods,PPK can explain the variation caused by various factors more conveniently and provide an important reference for clinical individualized medication.

关 键 词：群体药动学 NONMEM法 新药临床试验 

分 类 号：R969.1[医药卫生—药理学]