560例脉络舒通丸不良反应/事件报告分析  

560 cases of adverse drug reaction/event caused by Mailu Shutong pills

作　　者：王玉玺 张宗林[1] 王颖丽 陈亚飞 李俊生[1] 霍艳飞 谢彦军[3] 刘文启[1] WANG Yuxi;ZHANG Zonglin;WANG Yingli;CHEN Yafei;LI Junsheng;HUO Yanfei;XIE Yanjun;LIU Wenqi(Department of Pharmacy,Linyi People’s Hospital,Linyi Shandong 276000,China;Linyi Pharmacovigilance Center,Linyi Shandong 276000,China;Shandong Adverse Drug Reaction Monitoring Center,Jina Shandong 250000,China)

机构地区：[1]临沂市人民医院药学部,山东临沂276000 [2]临沂市药物警戒中心,山东临沂276000 [3]山东省药品不良反应监测中心,山东济南250000

出　　处：《中国药物警戒》2024年第8期921-924,930,共5页Chinese Journal of Pharmacovigilance

基　　金：山东省药品不良反应监测中心委托课题项目(2022SDADRKY21)。

摘　　要：目的分析脉络舒通丸不良反应/事件(ADR/ADE)发生特点,为临床安全用药提供参考。方法对山东省药品不良反应监测系统(2004年1月1日至2023年12月31日)中涉及脉络舒通丸560例ADR/ADE的报告类型、报告单位类别、年度变化、性别、年龄、累及系统-器官、临床表现、用药原因、合并用药和临床转归等进行分析。结果一般ADR/ADE 540例(96.43%);严重ADR/ADE 20例(3.57%),ADR/ADE主要累及系统-器官为胃肠系统、皮肤及其附件、全身性反应、中枢及外周神经系统。ADR/ADE主要临床表现为:恶心、呕吐、腹泻、瘙痒、皮疹。痊愈209例(37.32%),好转262例(46.79%),未好转19例(3.39%),不详70例(12.50%)。结论脉络舒通丸严重ADR/ADE报告占比较小,临床仍需关注,保障公众用药安全。Objective To analyse the characteristics of adverse drug reaction/event(ADR/ADE)induced by Mailuo Shutong pills,so as to provide reference for clinical safe medication.Methods Five hundred and sixty cases of ADR/ADE reports involving Mailuo Shutong pills in Shandong Province Adverse Drug Reaction Monitoring System between 2004 and 2023 were analyzed in terms of the types of reports,categories of reporting institutions,annual changes,gender,age,systemsorgans ADR/ADE involved,clinical manifestations,reasons for medication,combined medications and clinical outcomes.Results There were a total of 560 cases of ADR/ADE caused by Mailuo Shutong pills,540(96.43%)of which were normal ones,and 20(3.57%)were severe ones.The main systems-organs involved in ADR/ADE were the gastrointestinal system,skin and its accessories,systemic reactions,and the central and peripheral nervous system.The clinical manifestations of ADR/ADE were mostly nausea,vomiting,diarrhea,itching and rash.In 471 of these cases(84.11%),ADR/ADE had no significant effect on the preexisting diseases,but 19 s(3.39%)refused to improve,and 70(12.50%)lost contact.Conclusion The post-marketing safety of Mailuo Shutong pills is good,but there are occasionally serious adverse reactions.Clinicians need to be alert to potential risks to drug quality or medications.

关 键 词：脉络舒通丸 药品不良反应/事件 胃肠 皮肤 中枢神经 外周神经 安全 

分 类 号：R972[医药卫生—药品] R994.11[医药卫生—药学]