中药独家品种说明书安全性信息的评价研究  

Evaluation Study on Safety Information of Instructions for Exclusive Varieties of Chinese Materia Medica

作　　者：郑蕊 钟长鸣 关曼柯 陈诗琪[1] 李承羽 商洪才[1] Zheng Rui;Zhong Changming;Guan Manke;Chen Shiqi;Li Chengyu;Shang Hongcai(Ministry of Education and Beijing Key Laboratory of Chinese Internal Medicine,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]北京中医药大学东直门医院中医内科学教育部和北京市重点实验室

出　　处：《世界中医药》2019年第10期2578-2581,共4页World Chinese Medicine

基　　金：中共中央组织部第二批国家“万人计划”(2016)经费资助项目(W02020052)

摘　　要：近年对中成药说明书信息不全面的情况多有质疑。但目前情况到底如何尚无系统评估。本文从独家中药品种安全性信息入手,共收集692份说明书,其中包含521份处方药和171份非处方药。主要发现存在以下问题:对有毒、涉及十八反、十九畏药物警示不足,不良反应、药物相互作用、特殊人群用药等信息尚不明确。针对上述问题,本团队提出“三步走”策略,即转变认知、科研推进、公众科普,切实推进中成药说明书改进,适应“人人享有中医药服务”的临床迫切需求。There are many doubts about incomplete information in instructions of Chinese patent medicine in recent years.However,there is no systematic assessment on the current situation.In this paper,from safety information of exclusive varieties of Chinese materia medica,692 instructions are collected,including 521 prescription medicines and 171 OTC medicines.Main problems are found as follows:insufficient warning for toxic medicines and those involved in eighteen antagonisms and nineteen mutual inhibitions;and unclear information on adverse reactions,medicinal interactions and medication in special population.In response to the problems,“three-step”strategy is proposed.That is to change awareness,promote scientific research and popularize science among the public.It effectively promotes the improvement of Chinese patent medicine instructions to meet the urgent clinical needs that“everyone enjoys Chinese medicine services”.

关 键 词：中成药 独家品种 说明书 安全性 征靶关联法 不良反应 药物相互作用 医保目录 

分 类 号：R242[医药卫生—中医临床基础]