皮类药材安全分析与用药警戒思考  

Considerations on the Safety Analysis and Pharmacovigilance for Skin Type of Chinese Materials

作　　者：张媛凤 张冰[1,2] 林志健 郭鹏杰[1] 曲聪聪 Zhang Yuanfeng;Zhang Bing;Lin Zhijian;Guo Pengjie;Qu CongcongI(School of Chinese Pharmacy, Beijing University of Chinese Medicine, Beijing 100029, China;Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing University of Chinese Medicine)

机构地区：[1]北京中医药大学中药学院,北京100029 [2]北京中医药大学中药药物警戒与合理用药研究中心

出　　处：《中国药师》2018年第4期647-651,共5页China Pharmacist

基　　金：新奥奖教学奖基金项目(编号:1000062720062/009/001)

摘　　要：目的:梳理皮类药材相关的安全事件报道,深入分析其引发不良反应/事件(ADR/ADE)的原因,探讨临床皮类药材用药警戒。方法:系统检索近30年国内外文献报道,搜集和整理28味皮类药材的不良反应/事件报道,采用回顾性研究和统计学方法分析该类中药引发不良反应的特点及原因。结果:共收集到皮类药材安全问题相关的文献报道43篇,病例44例,涉及ADR/ADE的皮类药材共12味,占皮类药材品种数的42.85%。皮类药材ADR/ADE的临床表现主要为A型、B型,其中由个体差异、误用滥用、超剂量用药引发的过敏反应和毒性反应较为常见。结论:皮类药材发生ADR/ADE的数量相对较少,但仍应对其可能发生安全问题的因素加以警戒,从而提高临床安全合理用药水平。Objective： To analyze the characteristics and reasons of adverse drug reactions/adverse drug events （ADR/ADE） to provide suggestions for the pharmacovigilance and the rational use of skin type of Chinese materials. Methods： The literature reports on 28 kinds of skin type of Chinese materials over last 30 years were reviewed, and then the ADR/ADE characteristics and reasons were analyzed by a retrospective study and statistic methods. Results ： Totally 44 ADR/ADE cases were reported in 43 literatures, in which 12 kinds of skin type herbs were involved accounting for about 42.85% of the prepared slices of skin type of Chinese materials. Ac- cording to the analysis, there were two types of ADR/ADE （type A and type B）. Allergic reaction and toxic/side effects were the most common manifestations. The main influencing factors were individual differences, overdose, misuse and abuse and so on. Conclusion： Although there are a few of ADR/ADE reports on skin type of Chinese materials, it is still necessary to take pharmacovigilance actions so as to improve the safe and rational use.

关 键 词：皮类药材 药品不良反应 安全用药 合理用药 药物警戒 

分 类 号：R282.71[医药卫生—中药学]