乌拉地尔注射剂安全性风险分析  

Safety risk analysis of urapidil injection

作　　者：李水廷 王芳 王琨 刘永利 张钢平 毕雪艳 LI Shuiting;WANG Fang;WANG Kun;LIU Yongli;ZHANG Gangping;BI Xueyan(Handan Drug Monitoring Center,Handan 056000,China;Hebei Provincial Drug Alert Center,Shijiazhuang 050090,China)

机构地区：[1]邯郸市药品监测中心,河北邯郸056000 [2]河北省药物警戒中心,河北石家庄050090

出　　处：《临床医药实践》2025年第5期375-378,共4页Proceeding of Clinical Medicine

摘　　要：目的:分析乌拉地尔注射剂安全性风险,为临床安全合理用药提供参考。方法:对2007年12月1日-2024年6月30日河北省医疗机构、持有人报告的乌拉地尔注射剂不良反应发生特点及临床表现进行汇总分析;对2000年1月1日-2024年6月30日中国知网文献数据库相关不良反应报道进行整理。结果:2007年12月1日-2024年6月30日乌拉地尔注射剂不良反应报告共计192例,其中新的不良反应报告36例(18.75%),严重不良反应报告40例(20.83%);192例不良反应均在规定用法用量下使用后发生,并在停药或采取对症治疗后24 h内症状缓解或消失。结论:乌拉地尔注射剂可致过敏性休克等严重不良反应,临床应用需注意并做好相关防治措施。药品上市许可持有人应加强不良反应监测与评价的主体责任,及时完善乌拉地尔注射剂说明书安全性信息。Objective:To analyze the safety risk of urapid injection and provide reference for clinical safe and rational drug use.Methods:The characteristics and clinical manifestations of adverse reactions of urapidil injection reported by medical institutions and holders in Hebei Province from December 1,2007 to June 30,2024 were summarized and analyzed.The adverse drug reactions reported in the literature database of China HowNet from January 1,2000 to June 30,2024 were sorted out.Results:From December 1,2007 to June 30,2024,a total of 192 cases of uradier injection ad-verse reactions,including 36 cases of new adverse reactions(18.75%),and 40 cases of severe adverse reactions(20.83%).192 cases of adverse reactions occurred after use within the specified dosage and administration.and the symptoms were relieved or disappeared within 24 hours after drug withdrawal or symptomatic treatment.Conclusion:Urapidil injection can cause serious adverse reactions such as anaphylaxis.It is necessary to pay attention to its clinical application and take appropriate preventive and therapeutic measures.Drug marketing licensees should strengthen the main responsibility of monitoring and evaluation of adverse reactions,improve the safety information of urapidil injection specifications in a timely manner.

关 键 词：乌拉地尔注射剂 不良反应 风险 安全性 说明书 

分 类 号：R971[医药卫生—药品]