基于FAERS数据库的米那普仑不良反应信号挖掘

Adverse Drug Reaction Signal Mining of Milnacipran Based on FDA Adverse Event Reporting System Database

目的采用美国食品药品管理局不良事件报告系统(FAERS)数据库挖掘米那普仑的不良反应(ADR)信号,为临床安全用药提供参考。方法使用OpenVigil 2.1数据平台,收集米那普仑2004年1月至2024年3月的ADR报告。采用报告比值比(ROR)和比例报告比值(PRR)法挖掘米那普仑的ADR信号。结果获得以米那普仑为主要怀疑药物的ADR报告1952份,ADR信号110个,涉及19个系统器官分类,排序前5位的依次为精神病类、胃肠系统疾病、各类神经系统疾病、皮肤及皮下组织类疾病、各类检查;报告较多的ADR有恶心、头痛、多汗、头晕、呕吐等;发现了哮喘持续状态、双束支传导阻滞、杀人意念、前列腺炎、感受异常5个新的ADR。结论米那普仑在真实世界中发生的ADR与说明书多数一致,但也有新的ADR被发现,临床使用中应特别关注。本研究可为临床安全用药提供参考。

Objective To mine the adverse drug reaction(ADR)signals of milnacipran based on the database of FDA Adverse Event Reporting System(FAERS),so as to provide reference for the safe drug use in clinical practice.Methods The OpenVigil 2.1 data platform was used to collect the ADR reporting data of milnacipran from January 2004 to March 2024.The ADR signals of milnacipran mining was performed using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods.Results There were 1952 ADR reports with milnacipran as the primary suspected drug,and a total of 110 ADR signals were identified,involving 19 system organ categories,and the top 5 were psychiatric disorders,gastrointestinal disorders,nervous system disorders,skin and subcutaneous tissue disorders,investigations.The most frequently reported ADR signals included nausea,headache,hyperhidrosis,dizziness and vomiting etc.Five new ADRs were discovered,including status asthmaticus,bifascicular block,homicidal ideation,prostatitis and feeling abnormal.Conclusion Most of ADRs of milnacipran in the real world are generally consistent with the specification,but there are also some new ADRs that have been discovered and should be paid special attention in the clinic.The study can provide reference for safety of milnacipran use in clinic.