目的 系統(tǒng)梳理中國、美國、歐洲、日本藥品監(jiān)管機構(gòu)、非監(jiān)管機構(gòu)發(fā)布的藥物相互作用（DDI）指南，分析其在藥物開發(fā)和臨床管理中的應用，為我國DDI研究及監(jiān)管提供建議。方法 檢索PubMed、中國學術(shù)期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫（Wanfang Data）、維普生物醫(yī)學數(shù)據(jù)庫（VIP），補充檢索國家藥品監(jiān)督管理局（NMPA）、美國食品藥品監(jiān)督管理局（FDA）、歐洲藥品管理局（EMA）、英國藥監(jiān)機構(gòu)（MRHA）、日本藥品和醫(yī)療器械管理局（PMDA）、人用藥品技術(shù)要求國際協(xié)調(diào)理事會（ICH）、國際醫(yī)學科學組織理事會（CIOMS）、美國國立指南文庫（NGC）、MedSci、醫(yī)脈通網(wǎng)站等，收集中國、美國、歐洲、日本公開發(fā)布的DDI指南，檢索時限均為建庫至2023年5月31日。結(jié)果 共篩選出32部DDI指南，其中藥品監(jiān)管機構(gòu)發(fā)布16部，非監(jiān)管機構(gòu)發(fā)布16部。結(jié)論 DDI研究貫穿藥品非臨床研究、臨床研究及上市后評價等整個生命周期?，F(xiàn)已發(fā)布的DDI指南涵蓋了DDI體外實驗、臨床研究的各個方面，為藥品研發(fā)和臨床合理用藥管理提供實質(zhì)技術(shù)指導與核心信息。未來藥物研發(fā)階段需按照指南嚴格進行DDI體內(nèi)、體外評估；在臨床應用階段，指南可幫助臨床醫(yī)師了解藥物聯(lián)用的DDI機制、潛在后果及管理建議，以提高聯(lián)合用藥療效、減少風險；對于上市后再評價，各國應出臺相應DDI指南規(guī)范上市后新藥的DDI監(jiān)測流程，以建立健全DDI安全性監(jiān)管體系。

Objective To conduct a comprehensive review of the guidelines on drug-drug interactions (DDI) issued by pharmaceutical regulatory agencies and non-regulatory agencies in China, the United States, Europe and Japan. By analyzing the application of these guidelines in drug development and clinical management, the study aims to provide recommendations for DDI research and regulation in China. Methods Retrieval PubMed, CNKI, Wanfang and VIP database. Additionally, searches will be performed on NMPA, FDA, EMA, MHRA, PMDA, ICH, CIOMS, NGC, MedSci and the Yimaitong website. Available DDI guidelines from China, the United States, Europe and Japan were collected publicly. The search period for all databases was from the establishment of the database to May 31, 2023. Results A total of 32 DDI guidelines were selected, including 16 guidelines issued by pharmaceutical regulatory institutions and 16 guidelines issued by non-regulatory institutions. Conclusion DDI research spans the entire lifecycle of pharmaceuticals, including non-clinical trials, clinical trials and post-marketing evaluation. The currently available DDI guidelines cover various aspects of in vitro studies and clinical research, providing substantial technical guidance and core information for drug development and rational drug use management. In future stages of drug development, it is imperative to adhere to guidelines for rigorous in vitro and in vivo assessment of DDI. During the clinical application phase, these guidelines can assist healthcare professionals in understanding the DDI mechanisms, potential consequences, and management recommendations for drug combinations, thereby enhancing therapeutic efficacy and reducing risks associated with concomitant medication use. For post-marketing reassessment, it is recommended that each country implement corresponding DDI guidelines to regulate the DDI monitoring process for newly approved drugs. This will contribute to the establishment of a robust regulatory system ensuring the safety of DDI.

R969.2

中國藥品監(jiān)督管理研究會研究課題（2024-Y-Y-006）；臨床研究和成果轉(zhuǎn)化能力提升試點項目（DZMG-ZJXY-23002）