今日药学

2016, v.26(09) 626-629

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他克莫司在中国肾移植患者中的群体药代动力学研究
Population Pharmacokinetics of Tacrolimus in Chinese Recipients with Kidney Transplantation

龚丽娴;袁进;芮建中;陈文瑛;蒋建敏;徐新军;
GONG Lixian;YUAN Jin;RUI Jianzhong;CHEN Wenying;JIANG Jianmin;XU Xinjun;Guangzhou General Hospital of Guangzhou Military Command;Nanjing General Hospital of Nanjing Military Command;The First Affiliated Hospital of Guangzhou Medical University;Sun Yat-sen University;

摘要(Abstract):

目的考察肾移植患者口服他克莫司胶囊后常规监测血药浓度数据的群体药代动力学(PPK)特征,为临床进行个体化用药方案的调整提供参考依据。方法回顾性收集98例肾移植患者的363个FK506全血浓度数据,利用NONMEM软件进行PPK模型分析,考察性别、年龄、体质量、术后时间、剂量、合并用药、肝肾功能等因素对PPK参数的影响,得到最终回归模型。结果术后时间、千克体质量服药剂量(DKG,mg·kg(-1))影响FK506的清除率。最终模型为:CL=18.6×(DKG/0.072 9)(-1))影响FK506的清除率。最终模型为:CL=18.6×(DKG/0.072 9)(0.266),V=314L。结论 NONMEM法建立肾移植患者口服FK506的PPK模型,结合患者DKG可估算CL,用于调整给药方案。
OBJECTIVE To investigate the population pharmacokinetics of tacrolimus of the oral administration in Kidney transplant recipients,so as to obtain support for the adjustment of the regimen schedule and individualized dosage. METHODS FK506 trough concentration data in 98 recipients were estimated by nonlinear mixed effect model( NONMEM) program. The effects of gender( GEN),age( AGE),body weight( BW),post-operation days( POD),dosage,concurrent drug,liver function,kidney function on pharmacokinetics parameters were evaluated with structural parameter models. RESULTS The clearance rate( CL) of FK506 was influenced by POD and DKG. The final models of FK506 were: CL = 18. 6 ×( DKG / 0. 072 9)(0.266),V=314L。结论 NONMEM法建立肾移植患者口服FK506的PPK模型,结合患者DKG可估算CL,用于调整给药方案。
OBJECTIVE To investigate the population pharmacokinetics of tacrolimus of the oral administration in Kidney transplant recipients,so as to obtain support for the adjustment of the regimen schedule and individualized dosage. METHODS FK506 trough concentration data in 98 recipients were estimated by nonlinear mixed effect model( NONMEM) program. The effects of gender( GEN),age( AGE),body weight( BW),post-operation days( POD),dosage,concurrent drug,liver function,kidney function on pharmacokinetics parameters were evaluated with structural parameter models. RESULTS The clearance rate( CL) of FK506 was influenced by POD and DKG. The final models of FK506 were: CL = 18. 6 ×( DKG / 0. 072 9)(0.266),V = 314 L. CONCLUSION PPK models of FK506 in Kidney Transplantation have been established using NONMEM. The clearance rate of FK506 can be calculated according to DKG. The characteristic is useful for regulation the dose schedule.

关键词(KeyWords): 普乐可复;肾移植;群体药代动力学;NONMEM
tacrolimus;kidney transplantation;population pharmacokinetic;NONMEM

Abstract:

Keywords:

基金项目(Foundation): 广东省医院药学研究基金(2014A06);; 广州市科技计划项目(201509010012)

作者(Authors): 龚丽娴;袁进;芮建中;陈文瑛;蒋建敏;徐新军;
GONG Lixian;YUAN Jin;RUI Jianzhong;CHEN Wenying;JIANG Jianmin;XU Xinjun;Guangzhou General Hospital of Guangzhou Military Command;Nanjing General Hospital of Nanjing Military Command;The First Affiliated Hospital of Guangzhou Medical University;Sun Yat-sen University;

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