433例非甾体抗炎药物不良反应报告分析  

Analysis of 433 Reports of Adverse Reactions to NSAIDs

作　　者：王丽 于文雯 郭瑞惠 李敏 曹广生 戚迎梅 WANG Li;YU Wenwen;GUO Ruihui;LI Min;CAO Guangsheng;QI Yingmei(Jinan Adverse Drug Reaction and Medical Device Adverse Event Monitoring Center,Jinan 250013,China)

机构地区：[1]济南市药品不良反应和医疗器械不良事件监测中心,济南250013

出　　处：《中国医药指南》2024年第9期121-124,共4页Guide of China Medicine

摘　　要：目的通过对非甾体抗炎药物(NSAIDs)致药品不良反应(ADRs)进行分析,了解NSAIDs致ADRs发生特点,为临床合理安全用药作参考。方法收集2022年10月1日至2023年9月30日,国家药品不良反应监测系统接收的济南市范围内的所有NSAIDs相关ADRs报告,共计535例;剔除药品等相关信息不详报告,最终433例纳入统计分析,对报告一般情况、性别和年龄、NSAIDs类别、ADR发生时间、给药途径以及ADRs累及系统/器官和临床表现等进行统计分析。结果NSAIDs所致ADRs患者中,一般报告379例;严重ADR报告54例,转归情况大部分为痊愈或好转;男女性别比为1∶1.23,多发生于≥60岁人群(66.7%);NSAIDs涉及乙酸类(24.2%)、丙酸类(22.2%)、甲酸类(21.5%)等十大类别:ADRs发生时间≤1天(264例,61.0%);给药途径以口服(256例,59.1%)和静脉(133例,30.7%)为主。433例ADRs报告中累及多个系统/器官,共计551例次,其中排名前3位分别为胃肠系统(310,56.3%)、皮肤及其附件(122,22.1%)和视觉障碍(25,8.7%);54例严重报告累及多个系统/器官共计76例次,主要累及皮肤及其附件系统(40,52.6%)、胃肠系统(14,18.4%)和泌尿系统(4,5.3%),临床表现主要以皮疹、瘙痒、呕吐等为主。结论NSAIDs在临床上使用广泛,会导致不同程度ADRs,临床中应合理用药,确保用药安全。Objective To analyze adverse drug reactions(ADRs)caused by Nonsteroidal anti-inflammatory drugs(NSAIDs)in order to grasp the characteristics of ADRs of NSAIDs and provide reference for rational clinical use.Methods A total of 433 reports of ADR of NSAIDs were collected by the national ADR monitoring system(Jinan)from October 1,2022 to Septermber 30,2023.Patients'age and gender,times of occurrence,system-organs involved,and clinical manifestations were recorded and analyzed.Results Among these cases,379 genernal ADRs were reported,54 serious ADRs were reported,most of the cases were cured or improved.The ratio of males to females was 1∶1.23,and the incidence was higher in patients aged≥60(66.7%).NSAIDs involved 10 categories,acetic acids(24.2%),propionic acids(22.2%),formic acids(21.5%);There were 264 reports(61.0%)that documented the time ADR occurred(mainly within 1 day).The main routes of administration were oral administration(256,59.1%)and intravenous administration(133,30.7%).In 433 reports of ADRs,multiple systems/organs were involved,totaling 551 times.The top three were the gastrointestinal system(310,56.3%),skin and skin appendages(122,22.1%),and visual impairment(25,8.7%);54 severe reports involving multiple systems/organs totaling 76 times,mainly affecting the skin and its accessory system(40,52.6%),gastrointestinal system(14,18.4%),and urinary system(4,5.3%).Clinical manifestations mainly include rash,itching,vomiting,etc.Conclusions NSAIDs was widely used,which can cause ADRs of varying degrees.It is necessary to promote rational use of drug and ensure the safe drug use in clinic.

关 键 词：非甾体抗炎药物 自发报告 药品不良反应 合理用药 

分 类 号：R969.2[医药卫生—药理学]