3446例中药不良反应报告的分析

Analysis of 3446 cases of traditional Chinese medicine adverse reactions

目的了解发生中药不良反应患者一般资料、药品名称、用法用量、给药途径、主要临床表现、转归等,尤其新的、严重的药品不良反应。方法收集2004年1月~2012年6月东营地区(东营市药品不良反应监测中心提供数据)中药及其制剂引致的药品不良反应报表,进行回顾性分析。结果中药及其制剂引致的药品不良反应、药源性疾病共3446例,其中新的1511例,严重的366例。涉及603种中药,包括中药制剂599种,中草药4种。新的、严重的药品不良反应发生率高。结论急需建立中药制剂致药源性疾病的防御体系,对中药药品不良反应进行系统资料的收集、监测和分析,并通过有效途径及管理措施为临床医生提供合理用药信息及咨询服务,为药品管理行政部门提供修改说明书的依据,最大限度地降低药源性疾病发生,维护公众用药安全。

Objective To understand the general information,drug names,usage and dosage,drug administration routes, main clinical manifestations and prognosis of the patients having traditional Chinese medicine adverse reactions,espe- cially the new and severe ones.Methods The adverse drug reactions caused by traditional Chinese medicine and its preparation in Dongying district from Janumy 2004 to June 2012 were analyzed retrospectively （data provided by Dongying adverse drug reaction monitoring center）.Results There were a total of 3446 cases of drug-induced diseases caused by traditional Chinese medicine and its preparation,of which 1511 were ne^v and 366 were severe,involving 603 kinds of traditional Chinese medicine,599 kinds of traditional Chinese medicine preparation and 4 kinds of Chinese herbs.The incidences of new and severe adverse drug reactions were high.Conclusion It is urgent to establish a de- fense system against traditional Chinese medicine preparation induced diseases,which collects,monitors and analyzes the traditional Chinese medicine adverse drug reactions,and through effective approaches and management measures, provides rational drug use information and consultation services for clinicians,provides description amendment refer- ence for drug management and administration departments,and protect public drug use safety.