上海市浦东新区人民医院196例新的和严重的药品不良反应报告分析

袁　芳，黄　瑾，王　建，李璐奕(上海市浦东新区人民医院药剂科，上海　201299)



上海市浦东新区人民医院196例新的和严重的药品不良反应报告分析

袁芳*，黄瑾#，王建，李璐奕(上海市浦东新区人民医院药剂科，上海201299)

DOI10.14009/j.issn.1672-2124.2016.01.033

摘要目的：了解上海市浦东新区人民医院(以下简称“我院”)新的和严重的药品不良反应(adverse drug reaction，ADR)发生的特点。方法：采用回顾性方法，对我院2012—2014年上报的新的、严重的ADR进行统计和分析。结果：196例ADR中，新的ADR有166例，严重的ADR有30例，其中有1例严重的ADR导致患者死亡。引起新的和严重的ADR的药品中，中药制剂和抗微生物药所占比例较高；静脉给药和口服给药是最主要的给药途径；新的和严重的ADR涉及器官和(或)系统主要是神经系统、皮肤及其附件与消化系统。结论：临床药师定期对上报的ADR进行评价分析并及时反馈给临床，对典型的新的和严重的ADR案例进行重点跟踪分析，通过培训、加大宣传提高医护人员对ADR的重视，加强对特殊人群用药的监护和中药制剂与抗菌药物的监测，可减少或避免ADR的发生。

关键词药品不良反应； 新的； 严重的； 报告分析

Analysis on New and Severe Adverse Drug Reaction Reports in Pudong New Area People’s Hospital

YUAN Fang, HUANG Jin, WANG Jian, LI Luyi(Dept.of Pharmacy，Shanghai Pudong New Area People’s Hospital, Shanghai 201299, China)

ABSTRACTOBJECTIVE：To investigate the characteristics of new and severe adverse drug reactions(ADR) in Pudong New Area People’s Hospital(hereinafter referred to as “our hospital”). METHODS: Retrospective method was adopted, statistical analysis was conducted on new and severe ADR reported by our hospital during 2012-2014. RESULTS: Of the 196 cases of ADR, 166 were new ADR and 30 were severe, among which one case of severe ADR caused the death of patients. Of the drugs that induced new and sever ADR, traditional Chinese preparation and antimicrobial drugs dominated the main places; intravenous and oral administration were the main routes of administration. New and severe ADR-involved organs and (or) systems were focus on the nervous system, skin and accessories and digestive system. CONCLUSIONS: The clinical pharmacists are suppose to evaluate and analyze the reported ADR at regular intervals, give timely feedback to the clinic, and carry out trace analysis on typical new and severe. It is necessary to make the medical staffs to attach great importance to ADR through the training and publicity, strengthen the intensive care of medication in special crowd and monitoring of traditional Chinese preparation and antimicrobial drugs, so as to reduce or avoid the occurrence of ADR.

KEYWORDSAdverse drug reactions; New; Severe; Report analysis

根据2011年7月1日起实施的《药品不良反应报告和监测管理办法》第8章第63条规定[1]：新的药品不良反应(adverse drug reaction，ADR)是指药品说明书中未载明的；药品说明书中已有描述，但其发生性质、程度、后果或频率与说明书描述不一致或更严重的，按照新的ADR处理。严重ADR，是指因使用药品引起下列损害情形之一的反应：导致死亡；危及生命；致癌、致畸、致出生缺陷；导致显著的或者永久的人体伤残或者器官功能的损伤；……