摘要
目的系统梳理中国、美国、欧洲、日本药品监管机构、非监管机构发布的药物相互作用(DDI)指南,分析其在药物开发和临床管理中的应用,为我国DDI研究及监管提供建议。方法检索PubMed、中国学术期刊全文数据库(CNKI)、万方数据库(Wanfang Data)、维普生物医学数据库(VIP),补充检索国家药品监督管理局(NMPA)、美国食品药品监督管理局(FDA)、欧洲药品管理局(EMA)、英国药监机构(MRHA)、日本药品和医疗器械管理局(PMDA)、人用药品技术要求国际协调理事会(ICH)、国际医学科学组织理事会(CIOMS)、美国国立指南文库(NGC)、MedSci、医脉通网站等,收集中国、美国、欧洲、日本公开发布的DDI指南,检索时限均为建库至2023年5月31日。结果共筛选出32部DDI指南,其中药品监管机构发布16部,非监管机构发布16部。结论DDI研究贯穿药品非临床研究、临床研究及上市后评价等整个生命周期。现已发布的DDI指南涵盖了DDI体外实验、临床研究的各个方面,为药品研发和临床合理用药管理提供实质技术指导与核心信息。未来药物研发阶段需按照指南严格进行DDI体内、体外评估;在临床应用阶段,指南可帮助临床医师了解药物联用的DDI机制、潜在后果及管理建议,以提高联合用药疗效、减少风险;对于上市后再评价,各国应出台相应DDI指南规范上市后新药的DDI监测流程,以建立健全DDI安全性监管体系。
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.
作者
袁如月
杨秋波
杨天绎
张力
赵志刚
李新辰
李皎月
黄举凯
杨晓晖
YUAN Ruyue;YANG Qiubo;YANG Tianyi;ZHANG Li;ZHAO Zhigang;LI Xinchen;LI Jiaoyue;HUANG Jukai;YANG Xiaohui(Dongcheng Retired Cadre Recuperation Center,Beijing 100120,China;Weihai Wendeng District Traditional Chinese and Western Medicine Hospital,Weihai 264400,China;Rutgers University,New Brunswick,NJ 08901,USA;Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China;Dongzhimeng Hospital,Beijing University of Chinese Medicine,Beijing 100700,China)
出处
《药物评价研究》
北大核心
2025年第3期545-555,共11页
Drug Evaluation Research
基金
中国药品监督管理研究会研究课题(2024-Y-Y-006)
临床研究和成果转化能力提升试点项目(DZMG-ZJXY-23002)。
关键词
药物相互作用
指南
药物开发
临床管理
启示
drug-drug interaction
guidelines
drug development
clinical management
enlightenment
