中药药物警戒回顾与思考

doi:10.19803/j.1672-8629.20240307

摘要/Abstract

摘要： 目的探讨符合中药特点的中药药物警戒体系,为提高中药安全用药水平提供参考。方法通过梳理中药药物警戒的起源与发展,总结近年来监管机构在中药药物警戒领域开展的工作,分析讨论中药药物警戒的影响因素。结果自我国建立药物警戒制度以来,中药药物警戒法规体系建设不断完善,中药药物警戒工作取得一定成果,为指导中药安全用药提供参考。结论中药药物警戒应始终坚持以中医的“整体观”和“辨证论治”理论为指导,积极探索符合现代中药特点的评价方法,以指导临床安全有效使用中药,促进中药药物警戒高质量发展。

关键词: 中药, 药物警戒, 风险防控, 药品不良反应, 用药安全, 说明书修订

Abstract: Objective To explore a pharmacovigilance system of traditional Chinese medicine（TCM）that is compatible with the characteristics of traditional Chinese medicine in order to provide reference for safe use of TCM. Methods The origin and development of pharmacovigilance of TCM were reviewed, the undertakings by regulatory agencies in the field of pharmacovigilance of TCM in recent years were summarized, and the determinants of pharmacovigilance of TCM were discussed. Results Since the establishment of the pharmacovigilance system, the laws and regulations on pharmacovigilance of TCM have been improved, and pharmacovigilance of TCM has proved fruitful enough to provide reference for safe use of TCM. Conclusion Pharmacovigilance of TCM should always be guided by the TCM theories of “holistic view” and “syndrome differentiation and treatment”. Effort should be made to establish evaluation methods in line with the characteristics of modern TCM so as to facilitate the safe and effective use of traditional Chinese medicine in clinical practice and promote the high-quality development of pharmacovigilance of TCM.

Key words: Traditional Chinese Medicine, pharmacovigilance, risk prevention and control, adverse drug reaction, drug use safety, revision of instructions

中图分类号:

R926
R994.11

邵波, 郭晓昕. 中药药物警戒回顾与思考[J]. 中国药物警戒, 2024, 21(7): 741-745.

SHAO Bo, GUO Xiaoxin. Review of pharmacovigilance of traditional Chinese medicine[J]. Chinese Journal of Pharmacovigilance, 2024, 21(7): 741-745.

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