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.
作者
翟天野
吕炯贤
井源浩
杨天绎
黄一欢
刘岩
苏钰文
张力
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)
出处
《药物评价研究》
北大核心
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)。
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
drug-drug interaction
clinical study
clinical trial
real world study
model-informed drug development
artificial intelligence
