41例依替米星不良反应报告分析

Analysis of 41 cases of adverse drug reactions induced by etimicin

目的分析依替米星致药品不良反应(ADR)的特点及风险因素,为临床合理用药提供参考。方法对泰安市ADR监测数据库(2008年1月1日~2023年7月31日)中41例涉及依替米星的ADR报告进行回顾性分析。结果41例报告中,新的一般报告8例(19.51%),严重报告10例(24.39%)。男23例,女18例,患者年龄以45~64岁及65岁以上居多。既往有ADR史的患者2例。多数ADR发生在用药1 d内,累及系统主要为皮肤及其附件损害、胃肠系统损害、中枢及外周神经系统损害、肝胆系统损害等,主要表现为瘙痒、皮疹、恶心、呕吐、头晕、头痛、氨基转移酶升高等。结论依替米星说明书警示信息不足,药品生产企业需加强对上市后监测数据的研究,进一步完善说明书,增加过敏性休克等严重不良反应的提示。临床应重视老年患者超剂量用药风险并加强对患者肝肾功能的监测,保障患者用药安全。

Objective To analyze the characteristics of and risk factors for adverse drug reactions(ADR)induced by etimicin and provide reference for clinical rational drug use.Methods 41 ADR reports of etimicin in the ADR monitoring database of Tai'an city(January 1,2008 to July 31,2023)were retrospectively analyzed.Results Among 41 ADR reports,8 cases(19.51%)were new general ADR,and 10 cases(24.39%)were severe ADR.There were 23 males and 18 females involved,most of them were aged 45~64 years and more than 65 years old.2 cases were reported to have a history of ADR.Most of the ADR occurred within 1 day of medication,the systems involved were mainly skin and its attachments,gastrointestinal system,central and peripheral nervous systems,and hepatobiliary system.The main clinical manifestations included itching,rash,nausea,vomiting,dizziness,headache,and elevation of transaminase.Conclusion The warning information of the instructions for etimicin is inadequate.Drug manufacturers need to strenthen the investigation of the post-marketing data and improve the instructions.Anaphylactic shock and other serious ADR should be added into the instructions.Clinic should pay attention to the risk of overdose for elderly patients and strengthen the monitoring of hepatic and renal function to ensure their medication safety.