首页|41例依替米星不良反应报告分析

41例依替米星不良反应报告分析

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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。
Analysis of 41 cases of adverse drug reactions induced by etimicin
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.

EtimicinAverse drug reactionRetrospective analysisDrug instructions

马晓东、谢彦军、霍艳飞、王涛、李霞

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泰安市食品药品检验检测研究院,山东泰安 271000

山东省药品不良反应监测中心,济南 250014

依替米星 药品不良反应 回顾性分析 药品说明书

山东省药品不良反应监测中心科研项目

2023SDADRKY36

2024

中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
年,卷(期):2024.22(4)
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