药物相互作用临床研究方法及进展  

Methods and progress of clinical research on drug-drug interactions

作　　者：沙碧君 周素凤 王璐 赵玉清 陈西敬[1] 邵凤 SHA Bijun;ZHOU Sufeng;WANG Lu;ZHAO Yuqing;CHEN Xijing;SHAO Feng(Center of Drug Metabolism and Pharmacokinetics,China Pharmaceutical University,Nanjing 211198,Jiangsu,China;Phase I Clinical Trial Unit,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,Jiangsu,China)

机构地区：[1]中国药科大学药物代谢研究中心,江苏南京211198 [2]南京医科大学第一附属医院I期临床研究室,江苏南京210029

出　　处：《中国临床药理学与治疗学》2019年第9期1037-1045,共9页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：“重大新药创制”科技重大专项(2018ZX09734007);“创新药物临床评价的同位素示踪技术平台”

摘　　要：本文主要从CYP450酶介导的药物相互作用(drug-drug interactions,DDI)、转运体蛋白介导的DDI、临床合并用药中遇到的DDI以及通过计算机模型预测体内DDI这几个方面对药物相互作用进行探讨和总结。通过查阅药物相互作用相关文献、指南及相关的临床试验研究,以具体案例分析的方式,详细描述了药物相互作用的分类、临床研究设计方法及进展。总结了临床研究中采取的剂量调整、额外的治疗监测、联用禁忌或者其他降低危险的措施,为临床研究设计提供参考依据。In this review,the drug interactions were discussed and summarized from CYP450 enzyme-mediated drug-drug interaction(DDI),transporter protein-mediated DDI,DDI encountered in clinical combination therapy,and Silico DDI.By reviewing the literature,guidelines and related clinical trials of drug interactions and analyzing the specific cases,the classification of drug interactions,clinical research design methods and progress were described in detail.The dose adjustment,additional treatment monitoring,combined contraindications or other measures to reduce the risk in clinical research were summarized to provide references for clinical research design.

关 键 词：药物相互作用 CYP450 转运体蛋白 临床试验 

分 类 号：R969[医药卫生—药理学]