基于文献和药品说明书的依替米星不良反应分析  

Analysis of Adverse Drug Reactions Induced by Etimicin Based on Literature and Drug Instructions

作　　者：马晓东 谢彦军[2] 霍艳飞 王涛 徐滨 李霞 MA Xiaodong;XIE Yanjun;HUO Yanfei;WANG Tao;XU Bin;LI Xia(Department of Adverse Drug Reaction Monitoring,Tai’an Institute for Food and Drug Control,Tai’an 271000,Shandong,China;Department of Adverse Drug Reaction Monitoring,Shandong Center for Adverse Drug Reaction Monitoring,Jinan 250014,Shandong,China;Shandong Center for Adverse Drug Reaction Monitoring,Jinan 250014,Shandong,China)

机构地区：[1]泰安市食品药品检验检测研究院药品不良反应监测科,山东泰安271000 [2]山东省药品不良反应监测中心药品不良反应监测评价科,山东济南250014 [3]山东省药品不良反应监测中心,山东济南250014

出　　处：《中国药物滥用防治杂志》2024年第9期1605-1609,共5页Chinese Journal of Drug Abuse Prevention and Treatment

基　　金：山东省药品不良反应监测中心科研项目(编号:2023SDADRKY36)。

摘　　要：目的:分析依替米星致药品不良反应(ADR)的发生规律及特点,为临床合理用药提供参考。方法:检索中国知网、万方、维普、PubMed、Embase数据库(截至2023年12月)涉及依替米星的ADR个案报道,查询不同持有人药品说明书中的相关安全性信息,提取数据并进行统计分析。结果:共收集文献30篇,涉及患者33例,男女比例约为1∶1,年龄以40~49岁(24.24%)、50~59岁(18.18%)和60~69岁(18.18%)居多,有药物过敏史者6例(18.18%)。每日用量为0.05~0.3 g,涉及剂型以注射液较多(63.63%)。ADR发生时间多为用药30 min内(60.61%),主要累及全身性损害(31.58%)、中枢及外周神经系统损害(24.56%)、皮肤及其附件损害(10.53%)。各持有人的药品说明书不一致,相关安全性信息特别是ADR描述过于简单。结论:依替米星可致多种说明书未记载的ADR,累及多个系统/器官,应及时修订完善药品说明书。临床应用时要严格按照说明书使用,加强用药监护,备好急救药品,尽早发现和治疗ADR,保障患者用药安全。Objective:To analyze the occurrence regularity and characteristics of adverse drug reactions(ADR)induced by etimicin and provide reference for clinical rational drug use.Methods:Case reports of ADR induced by etimicin were retrieved from CNKI,Wanfang,VIP,PubMed,and Embase(by December,2023),the safety information in the drug instructions of different marketing authorization holders were compared,the data were extracted and statistically analyzed.Results:A total of 30 literatures were collected,involving 33 patients.The ratio of male to female was about 1∶1.The age was 40-49 years old(24.24%),50-59 years old(18.18%)and 60-69 years old(18.18%).There were 6 cases(18.18%)with a history of drug allergy.The daily dosage was 0.05-0.3 g,and most of the dosage forms were injection(63.63%).The occurrence time of ADR was mostly within 30 min(60.61%),mainly involving systemic damage(31.58%),central and peripheral nervous system damage(24.56%),skin and its appendages damage(10.53%).The drug instructions of each holder were inconsistent,and the relevant safety information,especially the ADR description,was too simple.Conclusion:Etimicin can induce a variety of ADR which are not described in the instructions,involving multiple systems/organs.The instructions should be improved and updated in time.The clinical application of etimicin should be strictly in accordance with the drug instructions.It is necessary to strengthen drug monitoring,prepare emergency medicine,identify ADR and give symptomatic treatment as soon as possible to ensure the safety of patients’medication.

关 键 词：依替米星 药品不良反应 文献分析 药品说明书 

分 类 号：R95[医药卫生—药学] G353.1[文化科学—情报学]