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.
Abstract
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,systems-organs 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.
基金项目
山东省药品不良反应监测中心委托课题项目(2022SDADRKY21)
维普
万方数据