药物相互作用临床研究进展  

Review on clinical study of drug-drug interaction

作　　者：翟天野 吕炯贤 井源浩 杨天绎 黄一欢 刘岩 苏钰文 张力[5] ZHAI Tianye;LÜJiongxian;JING Yuanhao;YANG Tianyi;HUANG Yihuan;LIU Yan;SU Yuwen;ZHANG Li(School of Pharmacy,Nanjing Medical University,Nanjing 211166,China;Department of Clinical Pharmacology,Sir Run Run Hospital,Nanjing Medical University,Nanjing 211166,China;Rutgers University,New Brunswick,NJ 08901,USA;Dongzhimeng Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China)

机构地区：[1]南京医科大学药学院,江苏南京211166 [2]南京医科大学附属逸夫医院临床药理研究中心,江苏南京211166 [3]罗格斯大学,新布朗斯维克,美国新泽西州089014 [4]北京中医药大学东直门医院,北京100700 [5]北京中医药大学东方医院,北京100078

出　　处：《药物评价研究》2025年第3期556-565,共10页Drug Evaluation Research

基　　金：中国药品监督管理研究会研究课题-基于多元证据体探索中成药安全性评价方法的研究(2024-Y-Y-006);临床研究和成果转化能力提升试点项目-中药制剂研发——治疗胃轻瘫中药复方佛香散(DZMG-ZJXY-23002)。

摘　　要：药物相互作用(DDI)临床研究的目的在于确认人体内是否会发生DDI并对其严重程度进行评估,为临床DDI防控策略制定提供科学依据。通过结合多项DDI临床研究具体案例,从独立或嵌套设计的DDI随机对照临床试验(RCT)及其事后分析,基于健康医疗数据或自发呈报不良反应报告的DDI真实世界研究,包括模型引导药物研发、机器学习和人工智能在内DDI计算机模拟研究、DDI文献研究,以及DDI临床研究内容与类型等方面,综述了DDI的临床研究现状。DDI相关真实世界数据和随机对照临床试验数据的链接和共享,将更有助于其计算机模拟研究的开展,以全面评估DDI临床效应与患者获益风险,从而为指导临床合理用药、保障公众用药安全提供科学的依据。The purpose of clinical research is to confirm whether drug-drug interactions(DDI)occur within the human body and to assess their severity,providing a scientific basis for the development of clinical DDI prevention and control strategies.This review provides a comprehensive review and discussion of the current status of DDI clinical research by examining diverse types of DDI studies,including independent or nested-design randomized controlled trials(RCTs)with post hoc analyses,real-world studies utilizing healthcare data or spontaneous adverse event reports,and computer simulation studies that incorporate model-informed drug development,machine learning,and artificial intelligence.Additionally,the paper covers DDI literature reviews and the types and content of various DDI clinical studies.The integration and sharing of real-world data and RCT data related to DDI will further advance computer simulation research,facilitating a thorough evaluation of DDI clinical effects and the benefit-risk profile for patients,ultimately guiding the rational use of medication in clinical practice and ensure the safety of public drug use,providing a scientific basis.

关 键 词：药物相互作用 临床研究 临床试验 真实世界研究 模型引导药物研发 人工智能 

分 类 号：R969.2[医药卫生—药理学]