外用中成药临床应用药物警戒指南  

Pharmacovigilance guidelines for clinical application of Chinese patent medicines for external use

作　　者：崔鑫 杨顶权[2] 谢振年[3] 黎元元[1] 王志飞[1] 刘峘[1] 刘福梅[1] 赵晓晓 路振凯 王连心[1] 谢雁鸣[1] CUI Xin;YANG Ding-quan;XIE Zhen-nian;LI Yuan-yuan;WANG Zhi-fei;LIU Huan;LIU Fu-mei;ZHAO Xiao-xiao;LU Zhen-kai;WANG Lian-xin;XIE Yan-ming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;China-Japan Friendship Hospital,Bejing 100029,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China)

机构地区：[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,北京100029 [3]中国中医科学院西苑医院,北京100091

出　　处：《中国中药杂志》2024年第16期4285-4290,共6页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划项目(2022YFC3502004,2018YFC1707400);国家自然科学基金面上项目(81973982);国家中医药管理局2021年歧黄学者支持项目(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)。

摘　　要：目前已上市的外用中成药种类及剂型众多,广泛应用于临床各科。外用中成药的常见不良反应主要以皮肤反应为主,罕见重症药品不良反应表现为心慌、胸闷、呼吸困难、过敏性休克等。查新结果显示,世界卫生组织(WHO)、国际人用药品注册技术协调会(ICH)、美国、欧盟、亚太(日本、韩国等)均无外用中成药药物警戒指南的发布。我国也尚未发布外用中成药药物警戒指南,仅有关于外用中成药致皮肤不良反应的标准——《外用中成药皮肤不良反应评价》(T/CACM 005-2017)。为进一步规范外用中成药的安全、合理使用,项目组邀请来自全国众多学科领域的专家共同研制了《外用中成药临床应用药物警戒指南》,对外用中成药在临床应用过程中的药品不良反应/事件监测与报告、信号识别、风险评估、风险控制等4个环节提出建议,指导临床合理使用外用中成药。同时列出外用中成药临床应用可能存在的风险及风险控制措施,以供临床借鉴,进而指导我国外用中成药药物警戒相关活动的规范开展。There are many kinds and dosage forms of Chinese patent medicines for external use on the market,which are widely used in clinical departments.The common adverse reactions of Chinese patent medicines for external use are skin reactions,and those for the rare severe diseases include palpitation,chest tightness,dyspnea,and anaphylactic shock.At present,World Health Organization(WHO),International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use(ICH),the United States,the European Union,and Asia-Pacific countries(such as Japan and South Korea)have not issued any pharmacovigilance guideline of Chinese patent medicines for external use.China has not issued any pharmacovigilance guideline for these medicines,only releasing the standard Evaluation of skin adverse reactions caused by Chinese patent medicines for external use(T/CACM 005-2017).To standardize the safe and reasonable use of Chinese patent medicines for external use,Pharmacovigilance guidelines for clinical application of Chinese patent medicines for external use was developed with the joint efforts of experts in diverse disciplines.The guideline provides guidance on the monitoring and reporting of adverse reactions/events,identification and assessment of risk signals,and risk control measures in the clinical application of Chinese patent medicines for external use to guide the rational use of these medicines in clinical practice.At the same time,the possible risks and risk control measures in clinical application of Chinese patent medicines for external use are listed for clinical reference.In addition,the guideline provides guidance for risk minimization plans and the standardization of activities related to pharmacovigilance of Chinese patent medicines for external use in China.

关 键 词：团体标准 外用中成药 指南 临床应用 药物警戒 

分 类 号：R288[医药卫生—中药学]