基于OpenFDA数据库的伏硫西汀不良事件报告信号挖掘与分析

Signal mining and analysis of vortioxetine adverse event reports based on OpenFDA database

目的对伏硫西汀安全警戒信号进行挖掘与分析,为临床安全用药提供参考。方法检索美国食品药品监督管理局公共数据公开项目(OpenFDA)2013年9月至2022年8月期间伏硫西汀不良事件报告数据,采用比值失衡法中的报告比值比法(ROR)和比例报告比值法(PRR)进行风险信号挖掘;采用《国际医学用语词典》的首选系统器官分类(SOC)对挖掘的信号进行统计分类和分析。结果共检索到伏硫西汀相关不良事件报告16569例,发生不良事件的群体以成年人为主,女性患者发生比例较高,占62.2%;上报报告国家排名前3位的分别是美国、法国、加拿大;上报人主要为消费者或非健康专业人员,占47.8%。主要适应证为抑郁症;严重不良事件占比45.1%。根据阳性标准共筛选出50个可疑信号,涉及10个SOC分类,其中精神疾病的信号数量最多(20个),其次为全身性疾病及给药部位各种反应(9个);50个可疑信号中有25个与说明书一致。在50个可疑信号中,信号强度排名前3位的分别是感到内疚(ROR=171.616,PRR=169.288)、食欲减退(ROR=92.452,PRR=91.141)和淡漠(ROR=38.309,PRR=37.404)。结论基于OpenFDA数据库对伏硫西汀的不良事件数据进行挖掘,有助于发现伏硫西汀在真实世界中的潜在不良反应风险信号,提示临床除了关注说明书上收录的不良反应外,还应重视说明书中未提及的这些潜在的风险信号,及时采取干预措施,保障患者用药安全。

Objective To evaluate the reports of adverse events of vortioxetine and data analysis to provide reference for drug safety in clinical practice.Methods The data of vortioxetine adverse events from September 2013 to August 2022 were retrieved from OpenFDA database,and risk signals were mined using the Reporting Odds Ratio(ROR)and Proportional Reporting Ratio(PRR)methods of the Ratio Imbalance Method.Statistical classification and analysis of the mined signals were performed using the preferred system organ class(SOC)of the Medical Dictionary for Regulatory Activities(MedDRA).Results Totally 16569 reports of vortioxetine related adverse events were retrieved,with a predominantly adult population and a higher proportion of female patients(62.2%).The top 3 reporting countries were USA,France and Canada.The reporting population was mainly consumers or non-health professionals,accounting for 47.8%.The main indication was depression.The proportion of serious adverse events was 45.1%.Fifty suspicious signals were screened according to the positive criteria,involving a total of 10 SOC classifications,with psychiatric disorders having the highest number of signals(20),followed by systemic disorders and various reactions at the site of administration(9).Twenty-five of the 50 suspicious signals were consistent with the instructions.Among the 50 suspicious signals,the top 3 signals in terms of intensity were feeling guilty(ROR=171.616,PRR=169.288),decreased appetite(ROR=92.452,PRR=91.141)and apathy(ROR=38.309,PRR=37.404).Conclusion Based on the OpenFDA database,the adverse event data of vortioxetine can help to identify the potential risk signals of vortioxetine in the real world,suggesting that clinics should pay attention to these potential risk signals not mentioned in the instructions,in addition to those included in the instructions,and take timely interventions to ensure the drug safety of patients.