181例严重药品不良反应/事件报告分析

Report Analysis of Serious Adverse Drug Reactions/Events of 181 Cases

目的:了解药品不良反应(ADR)的发生特点,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孝感市2011-2014年上报的ADR/药品不良事件(ADE)报告8 258例,纳入严重ADR/ADE报告181例,对发生ADR/ADE的患者性别、严重程度、相关性、药品类别、给药途经、累及器官及临床表现、严重ADR/ADE发生的特点进行统计分析。结果:181例严重ADR/ADE报告,主要来自医疗机构(173例,95.58%)和临床医师(104例,57.46%);引起ADR/ADE的药物为抗菌药物(97例,53.59%)和中药注射剂(23例,12.71%);引起ADR的给药途径以静滴多见(133例,73.48%);在181例严重ADR/ADE中,严重过敏性反应80例(42.20%),皮肤及附件损害36例(19.89%)。前3位的药品分别为头孢哌酮-舒巴坦(14例)、参麦注射液(10例)和头孢呋辛(10例)。结论:2011-2014年孝感市ADR/ADE高发于儿童和老年人,抗菌药物和中药注射剂以及静脉滴注给药,过敏反应最常见,临床用药中应予以重视。

Objective： To investigate the occurrence characteristics of adverse drug reactions so as to provide a reference for ADR monitoring. Methods： About 181 cases of severe ADRs/ADEs were extracted from 8 258 ADR/ADE cases reported by Xiaogan City to the National Adverse Drug Reaction Monitoring System from 2011 to 2014. A statistical analysis was made on the patient’s sex, severity, relativity of ADR/ADE, related drug species, route of administration, involving organs, clinical manifestations and occurrence characteristics of severe ADRs/ADEs. Results： About 181 case reports of severe ADR/ADE were mainly from medical institutions （173 cas-es, 95.58%） and clinical physicians （104 cases, 57.46%）, and ADRs/ADEs were mainly induced by antibacterials （97 cases, 53.59%）, Chinese medicine injections （23 cases, 12.71%） and intravenous dripping （133 cases, 73.48%）. Among 181 cases of severe ADRs/ADEs, there were 80 cases of severe allergic reactions （42.20%） and 36 cases of skin and appendages disorders （19.89% ）. The top three drugs causing ADR were cefoperazone sulbactam （14 cases）, shenmai injection （10 cases） and cefuroxime （10 cases）. Conclusion： From 2011 to 2014 the high inci-dence of ADR/ADE occurred in children and elderly people in Xiaogan city, and allergic reactions were mostly in-duced by antibacterial drugs, Chinese medicine injections and intravenous dripping. More attention should be paid to clinical medication.