国际风险信号优先评价原则的比较及对中药科学监管的启示  

International risk signal prioritization principles:comparison and implications for scientific regulation of traditional Chinese medicine

作　　者：郑蕊 刘硕 王诗佳 崔鹤蓉 宋海波 商洪才[1,5] ZHENG Rui;LIU Shuo;WANG Shi-jia;CUI He-rong;SONG Hai-bo;SHANG Hong-cai(Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing,Dongzhimen Hospital,Bejing University of Chinese Medicine,Beijing 100700,China;McMaster University,Hamilton L8N 1Y3,Canada;Center for Drug Reevaluation,National Medical Products Administration,Bejing 100037,China;School of Life Sciences,Beijing University of Chinese Medicine,Beijing 100029,China;Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China)

机构地区：[1]北京中医药大学东直门医院中医内科学教育部和北京市重点实验室,北京100700 [2]麦克马斯特大学,汉密尔顿L8N1Y3 [3]国家药品监督管理局药品评价中心,北京100037 [4]北京中医药大学生命科学学院,北京100029 [5]北京中医药大学东方医院,北京100078

出　　处：《中国中药杂志》2025年第1期273-277,共5页China Journal of Chinese Materia Medica

基　　金：中央高水平中医医院临床科研业务费项目(DZMG-QNGG0008);国家中医药管理局2021年歧黄学者支持项目;国家自然科学基金项目(82204937);北京中医药大学2023年岐黄英才计划项目(K2023C12);中央高校基本科研业务费专项(2024-JYB-KYPT-01)。

摘　　要：在药品安全监管中,信号检测是一项关键任务,但在这一过程中不可避免地会产生大量无价值或假信号,给药品持有人带来了资源分配的挑战。为了合理评估这些信号,国内外制定了不同的风险信号优先评价原则。该研究对这些原则的差异进行了系统比较,发现美国食品药品监督管理局(FDA)侧重于实践中的具体问题,如确认药品是否存在混淆使用或药物相互作用;我国《药物警戒质量管理规范》和欧洲药品管理局(EMA)更强调全面和系统的评估框架;而国际医学科学组织理事会(CIOMS)则注重多个数据源的一致性,强调信号评估的可靠性。鉴于我国实行中西医结合的多学科诊疗体系,中药风险信号具有成分复杂、毒性蓄积、独特理论支持及药物相互作用等特殊性。各国在风险信号优先评价原则上的不同侧重,启示我国在中药监管科学研究中,应加强临床试验研究,注重多来源证据的相互印证,并关注药物相互作用的风险。通过建立符合中医药特点的中药风险信号优先评价原则,能够实现更精准高效的中药科学监管。Signal detection is a critical task in drug safety regulation.However,it inevitably generates irrelevant or false signals,posing challenges for resource allocation by marketing authorization holders.To reasonably assess these signals,different countries have established various principles for prioritizing the evaluation of risk signals.This study systematically compares these principles and finds that the U.S.Food and Drug Administration(FDA)focuses on practical issues,such as identifying drug confusion or drug interactions.However,China′s Good Pharmacovigilance Practices and the European Medicines Agency(EMA)emphasize a comprehensive evaluation framework.The Council for International Organizations of Medical Sciences(CIOMS)emphasizes the consistency of multiple data sources,highlighting the reliability of signal evaluation.China practices a multidisciplinary approach combining traditional Chinese and western medicine,and the risk signals related to traditional Chinese medicine(TCM)have unique characteristics,including complex components,cumulative toxicity,specific theoretical foundations,and drug interactions.The different priorities in risk signal evaluation principles across countries suggest that China should strengthen clinical trial research,emphasize corroboration with evidence of multiple sources,and pay particular attention to the risks of drug interactions in the TCM regulatory science.Establishing the risk signal prioritization principles that align with the characteristics of TCM enables more precise and efficient scientific regulation of TCM.

关 键 词：药物警戒 风险信号 中药安全性 中药监管科学 药物相互作用 

分 类 号：R288[医药卫生—中药学]