【摘要】 目的　建立健康志愿者口服环孢素A(cyclosporinA ,CsA)微乳制剂药时曲线下面积 (AUC0 -12 )与药物不同时间浓度点之间的多元回归模型 ,以自举法 (Bootstrap)对该多元回归模型进行验证。 方法　 2 0名健康志愿者单剂量口服CsA微乳制剂 ,以有限抽样法 (LimitedSamplingStrategy ,LSS)建立回归数学模型 ,以Bootstrap法对多元回归模型进行参数估计、准确度检验及计算 95 %置信区间 (CI)。结果　Bootstrap法估算的回归模型参数分别为M1=2 662、M2 =6 14 7、Intercept =966 62。模型准确度参数分别为Adjr2 =0 9495、rmse =40 5 0 6、AIC =2 42 92、BIC =2 45 92。结论　以Bootstrap法对LSS法建立的多元回归模型进行参数估计、准确度检验准确性好 ,可以作为LSS模型验证的方法之一。更多还原

【Abstract】 Objective Establish the multi-regression model to estimate Cyclosporin A microemulsion areas under the curve in Chinese healthy volunteers by limited sampling strategy. Develop Bootstrap method for model validation.Methods A single dose of CsA microemulsion was administrated to 20 healthy volunteers. Multi-regression analysis were performed to establish a model to estimate AUC of CsA by LSS method. Estimation the parameters by Bootstrap method. The accuracy of model was estimated by Bootstrap procedure.Results The parameters by Bootstrap method was as follows:M 1=2.662、M 2=6.147、Intercept=966.62. Models accurate parameters was as follows: Adj r2=0.9495、rmse=405.06、AIC=242.92、BIC=245.92.Conclusion We developed a Bootstrap method for eastimation parameters and its 95% confident interval of LSS model. The method was as one of validation way for LSS model.更多还原