口服中成药临床应用药物警戒指南

Pharmacovigilance guidelines for clinical application of oral Chinese patent medicines

口服中成药是我国历代医药学家经过几千年医疗实践创造、总结的有效方剂的精华,具有疗效显著、便于携带、使用方便等特点。但目前,口服中成药剂型丰富、种类繁多、作用机制复杂、临床定位宽泛,临床应用中常出现超说明书用药、重复用药、用药时间过长等情况,使不良反应、肝肾毒性等安全性问题凸显,口服中成药药物警戒工作面临挑战。世界卫生组织(WHO)发布了《WHO药物警戒体系草药安全性监测指南》,国际人用药品注册技术协调会(ICH)发布了《ICH E2药物警戒指南系列》,美国出台《药物警戒管理规范与药物流行病学评估指南》,欧盟出台《药物警戒实践指南》,亚太地区的日本、韩国等已构建了自己的药物警戒体系,但目前国内尚无口服中成药相关的药物警戒指南。因此,邀请来自全国众多学科领域的专家共同研制了《口服中成药临床应用药物警戒指南》,旨在制订符合中国国情和突出口服中成药特点的临床应用药物警戒指南,为医疗机构临床安全、合理用药提供指导。

Oral Chinese patent medicine is the essence of effective prescriptions created and summarized by Chinese medical scientists through thousands of years of medical practice.It is portable and convenient,with an obvious curative effect and other characteristics.However,at present,oral Chinese patent medicine is rich in dosage forms,various in types,complex in mechanism of action,and broad in clinical positioning.In clinical application,there are often cases of drug use without reference to instructions,repeated drug use,and prolonged drug use,which highlights safety problems such as adverse reactions and hepatorenal toxicity.Oral Chinese patent medicine pharmacovigilance is facing challenges.World Health Organization(WHO)has issued the WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems,and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)has issued the ICH E2 pharmacovigilance guidelines.The United States has issued the Pharmacovigilance management standards and pharmacoepidemiological assessment guidelines,and the European Union has issued the Guidelines on good pharmacovigilance practices.Japan,South Korea,and other countries in the Asia Pacific region have established their own pharmacovigilance systems,but currently,there are no pharmacovigilance guidelines related to oral Chinese patent medicine in China.Therefore,experts from many disciplines and fields in China were invited to jointly develop the Pharmacovigilance guidelines for clinical application of oral Chinese patent medicines,which aims to develop pharmacovigilance guidelines for clinical application that are consistent with China's national conditions and highlight the characteristics of oral Chinese patent medicine,and provide guidance for clinically safe and rational drug application in medical institutions.