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.

R969.2

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）