中药制剂的安全性评价  

Safety of Traditional Chinese Medicine Preparations

作　　者：孙英英[1] 张东霞[1] 蒋士卿[1] 

机构地区：[1]河南中医学院第三附属医院药剂科,郑州450008

出　　处：《中国实验方剂学杂志》2011年第21期251-255,共5页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：目的:分析中药制剂不良反应(ADR)的特点、一般规律及影响因素,以促进临床合理用药。方法:采用回顾性分析方法,对我院2007至2009年收集到的70例中药制剂ADR报告分别从患者年龄、药品种类、给药途径、涉及器官或系统以及临床表现等方面进行统计、分析。结果:中药注射剂是引起ADR的主要剂型(91.63%);其中心脑血管用中药制剂引起的ADR所占比例最高(占中药制剂的60%)。结论:应及时报告中药制剂ADR,加强对其监测的意识,保障临床用药安全、有效。Objective：In order to promote rational drug use in the clinic,to analyze the characteristics,general patterns and influencing factors of adverse drug reaction（ADR） induced by traditional Chinese medicine preparations.Method：A retrospective analysis method was adopted.Seventy ADR case reports which were collected form 2006 to 2008 in our hospital were analyzed statistically in respect of patients＇ age,drug categories,routes of administration,organs and systems involved and clinical manifestations etc.Result：91.63% of the ADR were induced by traditional Chinese medicine injections.The injections in therapying cardiovascular and cerebrovascular diseases took the most（account for 60%）.Conclution：Timely reporting of traditional Chinese medicine preparation-induced ADRs,awareness on ADR monitoring should be strengthened to ensure safe and effective in the clinic.

关 键 词：不良反应 中药制剂 心脑血管用药 合理用药 

分 类 号：R287[医药卫生—中药学]