有限采样法估算中国健康志愿者氨氯地平药时曲线下面积  

Limited sampling strategy models for estimating AUC for amlodipine in Chinese healthy volunteers

作　　者：王鲲[1] 盛玉成[1] 何迎春[1] 杨娟[1] 张密[1] 许羚[1] 石劲敏[1] 郑青山[1] 

机构地区：[1]上海中医药大学药物临床研究中心,上海201203

出　　处：《药学学报》2010年第12期1582-1586,共5页Acta Pharmaceutica Sinica

基　　金：上海市教委创新项目(10YZ61);预算内科研项目(09JW17);上海市高校E研究院项目(E0308);创新团队建设项目和上海高校选拔培养优秀青年教师科研专项基金资助项目(szy08061)

摘　　要：This study aims to save cost of sampling for estimating the area under the amlodipine plasma concentration versus time curve in 24 hours(AUC0?24 h).Limited sampling strategy(LSS) models was developed and validated by mutilple regression model within 4 or fewer amlodipine concentration values.Absolute prediction error(APE),root of mean square error(RMSE) and visual predict check were used as criterion.The results of Jackknife validation showed that fifteen(9.4%) of the 160 LSS based on regression analysis were not within an APE of 15% by using one concentration-time point.156(97.5%),159(99.4%) and 160(100%) of the 160 LSS model were capable of predicting within an APE 15% by using 2,3,4 points,separately.Limited sampling strategies have been developed and validated for estimating AUC0?24 h of amlodipine.The present study indicated that the implemention of both 5 mg and 10 mg dosage could enable accurate predictions of AUC0?24 h by the same LSS model.This study shows that 12,4,24,2 h after administration are key sampling time points.The combination of(12,4),(12,4,24) or(12,4,24,2 h) might be chosen as sampling hours for predicting AUC0-24 h in practical application according to requirement.This study aims to save cost of sampling for estimating the area under the amlodipine plasma concentration versus time curve in 24 hours（AUC0？24 h）.Limited sampling strategy（LSS） models was developed and validated by mutilple regression model within 4 or fewer amlodipine concentration values.Absolute prediction error（APE）,root of mean square error（RMSE） and visual predict check were used as criterion.The results of Jackknife validation showed that fifteen（9.4%） of the 160 LSS based on regression analysis were not within an APE of 15% by using one concentration-time point.156（97.5%）,159（99.4%） and 160（100%） of the 160 LSS model were capable of predicting within an APE 15% by using 2,3,4 points,separately.Limited sampling strategies have been developed and validated for estimating AUC0？24 h of amlodipine.The present study indicated that the implemention of both 5 mg and 10 mg dosage could enable accurate predictions of AUC0？24 h by the same LSS model.This study shows that 12,4,24,2 h after administration are key sampling time points.The combination of（12,4）,（12,4,24） or（12,4,24,2 h） might be chosen as sampling hours for predicting AUC0？24 h in practical application according to requirement.

关 键 词：氨氯地平 有限采样法 JACKKNIFE BOOTSTRAP 药时曲线下面积 

分 类 号：R969[医药卫生—药理学]