4760例阿司匹林肠溶片不良反应报告分析

Analysis of 4760 ADR reports of aspirin enteric-coated tablets

目的:通过对阿司匹林肠溶片致不良反应报告进行分析,探讨其不良反应发生的特点,为临床合理用药提供建议。方法:采用回顾性分析方法,对全国2004–2017年度4760例阿司匹林肠溶片ADR报告进行统计分析。结果:4760例ADR报告中,男女比例为1.36∶1;不良反应病例61–70岁年龄段有峰值(30.44%);医疗机构上报4416例(92.77%);严重ADR报告占总体8.89%;ADR及严重ADR累及系统/器官主要为胃肠系统损害、皮肤及附件损害,主要表现为胃肠道出血、恶心、皮疹等。结论:临床用药应加强了解患者有无既往药品不良反应事件史,关注阿司匹林肠溶片严重ADR对原患疾病影响,加强对老年患者使用本品时的风险监测,并进一步加强企业风险管理意识。

Objective:To analyze the reports of adverse drug reactions(ADR)caused by aspirin enteric-coated tablets in order to provide suggestions for the rational drug use in clinical practice.Methods:A retrospective analysis was conducted on 4760 ADR reports of aspirin enteric-coated tablets from 2004 to 2017 in China.Results:In 4760 ADR reports,the ratio of male to female was 1.36:1.Most ADR cases(30.44%)were in the range of 61 to 70 years old.4416 cases(92.77%)were reported by medical institutions.The proportion of severe ADR reports was 8.89%.Gastrointestinal system,skin and appendant were mainly involved in ADR and severe ADR,which mainly manifested as gastrointestinal bleeding,nausea and rash.Conclusion:We should be awared of the patient’s history/event of ADR before medication,pay close attentions to the effect of severe ADR of aspirin enteric-coated tablets on the original disease and the potential risk of ADR caused by aspirin enteric-coated tablets in elderly patients.The consciousness of enterprise risk management should be further strengthened.