258例注射用肌氨肽苷不良反应报告分析

ANALYSIS 258 CASES OF ADVERSE REACTIONS INDUCED BY MUSCULAR AMINO ACIDS AND PEPTIDES AND NUCLEOSIDES FOR INJECTION

目的分析注射用肌氨肽苷所致不良反应和说明书安全性相关信息,为临床合理用药提供参考。方法对近5年国家药品不良反应监测系统内蒙古自治区收到的注射用肌氨肽苷不良反应报告进行数据整理,分析不良反应报告的类型、患者性别、年龄、原患疾病、不良反应和系统-器官分类、不良反应发生时间和转归等并对注射用肌氨肽苷说明书安全性相关内容进行比较分析。结果258例患者中,男性123例(47.67%,123/258),女性135例(52.33%,135/258);年龄61~70岁患者占比最高为97例(37.60%,97/258);原患疾病中脑梗死占比最高为118例(45.74%,118/258),其次是冠状动脉粥样硬化性心脏病17例(6.59%,17/258)。严重不良反应报告8例(3.10%,8/258),新的不良反应报告161例(62.40%,161/258),新的和严重不良反应报告占报告总数62.40%(161/258)。按照监管活动医学词典(MedDRA),不良反应累及的系统器官包括皮肤及皮下组织类疾病、全身性疾病及给药部位各种反应、各类神经系统疾病等多个系统器官。不良反应主要发生在静脉滴注过程中。病情转归基本为好转或痊愈。结论临床应加强用药监护。一旦发生不良反应应积极采取减慢静脉滴注速度、停药和对症治疗等干预措施,避免严重不良反应的发生。建议药品上市许可持有人关注说明书中未记载的不良反应,分析其安全风险,必要时应完善说明书不良反应等安全性相关信息。

Objective To analyze the adverse reactions induced by muscular amino acids and peptides and nucleosides for injection and the safety related information in the instructions,so as to provide reference for rational drug use in clinic.Methods The data of adverse reaction reports of muscular amino acids and peptides and nucleosides for injection received from the database of inner mongolia autonomous region of the national adverse drug reaction monitoring system in recent 5 years were normalized,and the types of adverse reaction reports,patient gender,age,primary diseases,adverse reactions and systems-organ classwereanalyzed.Results Amongthe258patients,therewere123males(47.67%,123/258)and135females(52.33%,135/258);the highest proportion of patients aged 61-70 years was 97 cases(37.60%,97/258);among the original diseases,the highest proportion of cerebral infarction was 118 cases(45.74%,118/258),followed by 17 cases of coronary atherosclerotic heart disease(6.59%,17/258).Serious adverse reactions were reported in 8 cases(3.10%,8/258),new adverse reactions were reported in 161cases(62.40%,161/258),and new and serious adverse reactions accounted for 62.40%(161/258)of the total number of reports.According to the MedDRA,adverse reactions involved skin and subcutaneous tissue disorders,general disorders and administration site conditions,nervous system disorders and many other system organ classes.Adverse reactions mainly occurred during intravenous drip.The prognoses of patients are basically improvement or recovery.Conclusions Clinicalmonitoringofmedication should be strengthened.In case of adverse reactions,intervention measures such as slowing down the speed of intravenous drip,drug withdrawal and symptomatic treatment should be actively taken to avoid serious adverse reactions.It is suggested that the drug marketing license holder should pay attention to the adverse reactions not recorded in the instructions,analyze the safety risks,and improve the safety related information such as adverse reactions in the instructions if necessary.