中药注射剂临床应用药物警戒指南
Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections
付常宽 1刘峘 1王连心 1邹忆怀 2黎明全 3林亚明 4孙维红 5魏戌 6胡聿尔 1谢雁鸣 1黎元元1
作者信息
- 1. 中国中医科学院 中医临床基础医学研究所,北京 100700
- 2. 北京中医药大学 东直门医院,北京 100700
- 3. 长春中医药大学 附属第三临床医院,吉林 长春 130117
- 4. 云南省中医医院,云南 昆明 650021
- 5. 宁夏医科大学 总医院,宁夏 银川 750004
- 6. 中国中医科学院 望京医院,北京 100102
- 折叠
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.
Abstract
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.
关键词
中药注射剂/药物警戒/中药药物警戒/团体标准/指南Key words
traditional Chinese medicine injections/pharmacovigilance/traditional Chinese medicine pharmacovigilance/group standard/guideline引用本文复制引用
基金项目
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)
出版年
2024
NETL
NSTL
万方数据