摘要
2019年,新修订的《中华人民共和国药品管理法》发布实施,明确提出我国建立药物警戒制度。中药注射剂作为中药新剂型,临床应用广泛,其药物警戒备受关注。针对这一现状,项目组召集全国多位临床、药学、循证医学专家组成专家组,严格遵循中华中医药学会团体标准的要求,制订《中药注射剂临床应用药物警戒指南》,旨在从临床应用的角度,依据我国药物警戒法规,并借鉴国外药物警戒指南,考虑中药注射剂临床应用药物警戒的关键要素,从监测与报告、信号识别、风险评估、风险控制等4个关键环节,对中药注射剂临床应用药物警戒工作提出建议。
In 2019,the newly revised Drug Administration Law of the People's Republic of China was issued and implemented,clearly proposing that China should establish a pharmacovigilance system.As a new traditional Chinese medicine(TCM)dosage form created in China,TCM injections have been widely used in clinic,and its pharmacovigilance has attracted much attention.In response to this situation,the project team convened a group of clinical,pharmaceutical and evidence-based medicine experts from all over the country to form an expert group,which formulated the Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections in strict accordance with the requirements of the group standards of the Chinese Association of Chinese Medicine.From the perspective of clinical application and considering the key elements of pharmacovigilance for clinical application of TCM injections,the guidelines put forward suggestions on the decision making of pharmacovigilance for clinical application of TCM injections from four key links,namely the monitoring and reporting,signal recognition,risk assessment and risk control,according to China's pharmacovigilance regulations and learning from foreign pharmacovigilance guidelines.
作者
付常宽
刘峘
王连心
邹忆怀
黎明全
林亚明
孙维红
魏戌
胡聿尔
谢雁鸣
黎元元
FU Chang-kuan;LIU Huan;WANG Lian-xin;ZOU Yi-huai;LI Ming-quan;LIN Ya-ming;SUN Wei-hong;WEI Xu;HU Yu-er;XIE Yan-ming;LI Yuan-yuan(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;the Third Afiliated Hospital of Changchun University of Chinese Medicine,Changchun 130117,China;Yunnan Provincial Hospital of Traditional Chinese Medicine,Kunming 650021,China;General Hospital of Ningxia Medical University,Yinchuan 750004,China;Wangjing Hospital,China Academy of Chinese Medical Sciences,Bejing 100102,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2024年第16期4279-4284,共6页
China Journal of Chinese Materia Medica
基金
国家重点研发计划项目(2018YFC1707400)
中央级公益性科研院所基本科研业务费专项(Z0737)
全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]75)
国家中医药管理局2021年岐黄学者支持项目(国中医药人教函[2022]6)
中国中医科学院科技创新工程中医临床基础学科创新团队项目(CI2021B003)
中国中医科学院科技创新工程项目(CI2021A00702)。
关键词
中药注射剂
药物警戒
中药药物警戒
团体标准
指南
traditional Chinese medicine injections
pharmacovigilance
traditional Chinese medicine pharmacovigilance
group standard
guideline
