2011～2014年安陆市药品不良反应报告回顾性分析  

Retrospective Analysis of Adverse Drug Reaction Reports from 2011 to 2014 in a City

作　　者：文加勇 张万智[1] 江福海 

机构地区：[1]安陆市普爱医院药剂科,湖北安陆432600 [2]安陆市食品药品监督管理局

出　　处：《药物流行病学杂志》2015年第7期415-418,共4页Chinese Journal of Pharmacoepidemiology

摘　　要：目的：了解安陆市药品不良反应（ADR）的发生特点和数据处理方法，为ADR监测工作提供参考。方法：提取国家药品不良反应监测系统中该市2011～2014年上报的ADR报告1309份，统计报告来源、患者性别、药品种类、给药途径、ADR累及器影系统等项目并作数据处理。结果：1309份ADR报告主要来自医疗机构（93．12％），引起ADR的药物以抗感染药多见（54．24％），其中以-β-内酰胺类抗菌药构成比最高（56．34％）；引起ADR的给药途径以静滴多见（86．94％）；ADR主要累及皮肤及附件（41．94％）和消化系统（36．13％）；严重ADR11例（0．84％），以严重过敏性休克为主（72．73％）。结论：增加ADR监测的覆盖面，加强严重ADR的监测，不断提高ADR监测水平，降低用药风险。Objective：To investigate the occurrence characteristics of adverse drug reactions and data processing methods in order to provide a reference for ADR monitoring. Methods： 1309 cases of ADR reports were downloaded from the National Adverse Drug Reaction Monitoring System from 2011 to 2014 in a city. The report source, patient sex, drug type, route of administration, ADR involving the organ / system were statistics and Excel 2003 and IBM SPSS 19.0 were used for data processing. Results ：1309 cases of ADR were reported mainly by medical institutions （93.12%）, and were mainly caused by anti-infectives （54.24%）. Among the anti-infectives the highest percentage （56.34%） were caused by β-lactams drugs. ADR were common caused by intravenous （86.94%）. Skin and accessories （41.94%） and digestive system （36.13%） were the mainly involving organs of ADR. 11 cases （0.84%） serious ADR were mainly caused by se- vere anaphylactic shock （72.73%）. Conclusion：It was necessary to increase monitoring coverage of ADR and strengthen the monitoring of serious ADR, and constantly improve the level of ADR monitoring, reduce the risk of medication.

关 键 词：药品不良反应 报告 监测 回顾性分析 

分 类 号：R951[医药卫生—药学]