基于美国FDA不良事件数据库的依瑞奈尤单抗不良反应信号挖掘

Adverse drug reaction signal mining of erenumab based on FDA adverse event reporting database

目的:挖掘依瑞奈尤单抗的药品不良反应(adverse drug reaction,ADR)信号,为其临床安全合理使用提供参考。方法:基于美国FDA不良事件报告系统,采用报告比值比法和比例报告比值法对FDA不良事件数据库中于2018年5月至2022年9月上报的依瑞奈尤单抗ADR报告进行数据挖掘,统计报告病例的性别、年龄等基本信息,对新的ADR信号进行分析。结果:以依瑞奈尤单抗为怀疑药物的ADR报告有9890例,其中女性(6215例,占62.84%)多于男性(845例,占8.54%);年龄主要在45~64岁;上报年份主要集中在2019年;主要上报国家为美国。共挖掘得到ADR信号53个,涉及系统器官分类13个,主要集中在全身性疾病及给药部位各种反应、胃肠系统疾病、皮肤及皮下组织类疾病和生殖系统及乳腺疾病。除说明书已经收录的注射部位反应、便秘、脱发等ADR,还挖掘出雷诺现象、心血管相关不良反应、月经异常等新的ADR信号。结论:临床应用依瑞奈尤单抗时,除药品说明书中已提到的ADR外,还应密切关注雷诺现象和月经异常现象,并对患者心血管风险进行监测。

OBJECTIVE To assess the adverse drug reaction(ADR)signals of erenumab,so as to provide reference for rational and safe drug use in clinic.METHODS Based on FDA adverse event reporting database,the reporting odds ratio and proportional reporting ratio methods were used for data mining of adverse events related to erenumab during from May 2018 to September 2022.The demographic characteristics including sex and age were described,and signals of ADR were analyzed.RESULTS In total,9890 ADR reports were identified for erenumab.The female(6215 cases,62.84%)was more than the male(845 cases,8.54%).Cases reported in the age range 45~64 were most frequent.Most of reports were came from America and the number of cases had a peak in 2019.Fifty-three ADR signals were detected,corresponding thirteen system organ class(SOC).The SOC of erenumab ADR signals mainly focused on general disorders and administration site conditions,gastrointestinal disorders,skin and subcutaneous tissue disorders,reproductive system and breast disorders.Except for injection site reaction,constipation and alopecia,which had been recorded in the drug instruction,we also assessed the new ADR signals,such as raynaud’s phenomenon,cardiovascular related adverse reactions and menstruation irregular.CONCLUSION In the clinical application of erenumab,in addition to ADR mentioned in the drug instructions,close attention should be paid to the raynaud’s phenomenon and menstruation irregular,as well as cardiovascular risk monitoring.