南京医科大学学报（自然科学版）2017，Vol.37Issue(9)：1193-1199,7.DOI:10.7655/NYDXBNS20170925
肾移植患者西罗莫司的群体药代动力学模型研究
Study on population pharmacokinetics model of sirolimus in renal transplantation patients
摘要
Abstract
:Objective:To construct a population pharmacokinetics(PPK) model of sirolimus in Chinese renal transplantation patients,study the pharmacological characteristics of sirolimus,and provide theory support for personalized drug use.Methods:One hundred and eleven renal transplantation patients,who were orally administrated with sirolimus after transplantation,were enrolled in the study.Steady-state concentrations of sirolimus and related laboratory test results were retrospectively collected.Phoenix NLME was used to perform a population pharmacokinetics model.Influence factors on pharmacokinetic parameter were analyzed.Performance of final model was internally assessed by bootstrapping and visual predictive checking (VPC).Results:A one-compartment model with first-order elimination pharmacokinetics provided the best fitting.In all fixed effects,hematocrit influenced the clearance of sirolimus,alkaline phosphatase influenced volume of distribution.Typical value of CL/F was 10.8 L/h,typical value of V/F was 1011 L.Stability and predictive performance were accepted by bootstrapping and VPC.Conclusion:A PPK model of sirolimus in Chinese renal transplantation patients is successfully established in this study.Effects of weight,age,gender,drug dose,drug combination,liver and kidney function on pharmacokinetic parameter were inspected.It is of great significance for clinical rational drug use of simlimus.关键词
西罗莫司/肾移植/群体药动学/治疗药物监测Key words
sirolimus/renal transplantation/population pharmacokinetics/therapeutic drug monitoring分类
医药卫生引用本文复制引用
张钰,王永庆,张宏文,杨劲,吴延庆,谭若芸,王丽彬,刘云,王源园,魏继福..肾移植患者西罗莫司的群体药代动力学模型研究[J].南京医科大学学报（自然科学版）,2017,37(9):1193-1199,7.基金项目
南京市科技发展指导性计划(2016YX006) （2016YX006）
南京药学会—常州四药医院药学科研基金 （）
