目的 基于构建生理药动学（physiologically-based pharmacokinetics，PBPK）模型的方法，对五味子甲素与西罗莫司之间的药物-药物相互作用（drug-drug interaction，DDI）特征进行研究。方法 应用PK-Sim^®软件，建立西罗莫司、五味子甲素的PBPK模型，经验证用于预测成人及儿童中的DDI。结果 联用五味子甲素时，成人中西罗莫司的最大血浆药物浓度（maximum concentration，C_max）和血药浓度-时间曲线下面积（area under the plasma concentration-time curve，AUC）分别升高至1.0、1.3倍。0～6岁的儿童群体DDI较成人更加显著，C_max和AUC的变化比率分别为1.63和4.59，且随着年龄逐渐增加，最终与成人DDI程度持平。结论 五味子甲素可增加西罗莫司的疗效，且与年龄有关。临床使用五味子甲素与西罗莫司的联用时，应重视血药浓度监测并及时进行剂量调整，尤其是在儿童群体中。

Objective To study the characteristics of drug-drug interaction (DDI) between schisandrin A (SIA) and sirolimus (SRL) using a physiologically based pharmacokinetics (PBPK) model. Methods The PBPK model of SIA and SRL was established by using PK-Sim^® software, which was verified for predicting DDI in adults and children. Results When combined with SIA, maximum concentration (C_max) and area under the plasma concentration-time curve (AUC) of SRL in adults were increased to 1.0 and 1.3 times, respectively. The DDI of children aged 0—6 years was more significant than that of adults, and the change rates of C_max and AUC were 1.63 and 4.59, respectively. With age increasing gradually, the DDI degree was equal to that of adults. Conclusion SIA can increase the efficacy of SRL, and its effect is related to age. In the clinical use of SIA and SRL, blood concentration monitoring and dose adjustments should be taken into account, especially in children.

R285.62

天津市卫生健康行业高层次人才选拔培养工程（TJSJMYXYC-D2-031）