《外用中成药临床应用药物警戒指南》解读与启示

doi:10.19803/j.1672-8629.20240349

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (9): 1029-1033.
DOI: 10.19803/j.1672-8629.20240349

《外用中成药临床应用药物警戒指南》解读与启示

路振凯¹, 杨顶权², 谢振年³, 王连心¹, 黎元元¹, 王志飞¹, 崔鑫^1#, 谢雁鸣^1,*

¹中国中医科学院中医临床基础医学研究所,北京 100700;
²中日友好医院皮肤科,北京 100029;
³中国中医科学院西苑医院肛肠科,北京 100091

收稿日期:2024-05-24 出版日期:2024-09-15 发布日期:2024-09-14
通讯作者: ^*谢雁鸣,女,首席研究员,中药上市后循证评价。E-mail: ktzu2018@163.com。^#为共同通信作者。
作者简介:路振凯,男,在读博士,中药上市后循证评价。
基金资助:
国家重点研发计划（2022YFC3502004、2018YFC-1707400）; 国家中医药管理局2021歧黄学者支持项目（国家中医药人教函[2022]6）; 谢雁鸣全国名老中医药专家传承工作室建设项目（国家中医药人教函[2022]75）; 中央级公益性科研院所基本科研业务费专项（Z0737）

Interpretation and insights from the “Guidelines for Pharmacovigilance of Topical Traditional Chinese Medicines in Clinical Applications”

LU Zhenkai¹, YANG Dingquan², XIE Zhennian³, WANG Lianxin¹, LI Yuanyuan¹, WANG Zhifei¹, CUI Xin^1#, XIE Yanming^1,*

¹Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
²Department of Dermatology, China-Japan Friendship Hospital, Beijing 100029, China;
³Department of Anorectal Diseases, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China

Received:2024-05-24 Online:2024-09-15 Published:2024-09-14

摘要/Abstract

摘要： 目的介绍《外用中成药临床应用药物警戒指南》（简称“《指南》”）核心内容,为规范我国外用中成药药物警戒相关活动及临床实践提供参考。方法总结《指南》中外用中成药的传统剂型,详细解读外用中成药在临床应用中可能存在的风险及控制措施。结果梳理《指南》重点强调的含矿物中药材、含毒性成分的中药材以及儿科、老年及孕妇等特殊人群的用药安全,并提供详尽的风险评估与控制措施。结论外用中成药的临床不合理应用导致用药风险增加,《指南》为规范化开展外用中成药临床应用的药物警戒工作提供借鉴。

关键词: 外用中成药, 不良反应, 风险控制, 药物警戒, 解读

Abstract: Objective To guide the “Guidelines for Pharmacovigilance of Topical Traditional Chinese Medicines in Clinical Applications” (referred to as the “Guidelines”), providing a reference for standardizing pharmacovigilance activities and clinical practices related to topical traditional Chinese medicines (TCMs) in China. Methods Summarize the traditional formulations of topical TCMs mentioned in the “Guidelines”, and provide a detailed interpretation of the potential risks and control measures in the clinical application of topical TCMs. Results The Guidelines highlight the safety of medications containing mineral Chinese medicinal materials, toxic Chinese medicinal materials, and the use of TCMs in special populations such as pediatric, elderly, and pregnant patients. Comprehensive risk assessment and control measures are provided. Conclusion The irrational clinical application of topical TCMs increases the risk of medication-related adverse events. The guidelines offers valuable reference and guidance for better standardizing pharmacovigilance activities in the clinical application of topical TCMs.

Key words: external TCM preparations, adverse reactions, risk control, drug safety monitoring, interpretation

中图分类号:

R994.11

路振凯, 杨顶权, 谢振年, 王连心, 黎元元, 王志飞, 崔鑫, 谢雁鸣. 《外用中成药临床应用药物警戒指南》解读与启示[J]. 中国药物警戒, 2024, 21(9): 1029-1033.

LU Zhenkai, YANG Dingquan, XIE Zhennian, WANG Lianxin, LI Yuanyuan, WANG Zhifei, CUI Xin, XIE Yanming. Interpretation and insights from the “Guidelines for Pharmacovigilance of Topical Traditional Chinese Medicines in Clinical Applications”[J]. Chinese Journal of Pharmacovigilance, 2024, 21(9): 1029-1033.

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《外用中成药临床应用药物警戒指南》解读与启示

Interpretation and insights from the “Guidelines for Pharmacovigilance of Topical Traditional Chinese Medicines in Clinical Applications”

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