藥物相互作用（DDI）臨床研究的目的在于確認人體內(nèi)是否會發(fā)生DDI并對其嚴重程度進行評估，為臨床DDI防控策略制定提供科學依據(jù)。通過結(jié)合多項DDI臨床研究具體案例，從獨立或嵌套設計的DDI隨機對照臨床試驗（RCT）及其事后分析，基于健康醫(yī)療數(shù)據(jù)或自發(fā)呈報不良反應報告的DDI真實世界研究，包括模型引導藥物研發(fā)、機器學習和人工智能在內(nèi)DDI計算機模擬研究、DDI文獻研究，以及DDI臨床研究內(nèi)容與類型等方面，綜述了DDI的臨床研究現(xiàn)狀。DDI相關真實世界數(shù)據(jù)和隨機對照臨床試驗數(shù)據(jù)的鏈接和共享，將更有助于其計算機模擬研究的開展，以全面評估DDI臨床效應與患者獲益風險，從而為指導臨床合理用藥、保障公眾用藥安全提供科學的依據(jù)。

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

中國藥品監(jiān)督管理研究會研究課題-基于多元證據(jù)體探索中成藥安全性評價方法的研究（2024-Y-Y-006）；臨床研究和成果轉(zhuǎn)化能力提升試點項目-中藥制劑研發(fā)——治療胃輕癱中藥復方佛香散（DZMG-ZJXY-23002）