基于FAERS数据库的维立西呱不良事件的真实世界研究

Real-world study of adverse events associated with vericiguat based on FAERS

目的 利用美国食品药品管理局(FDA)不良事件报告系统(FAERS)数据库分析维立西呱在真实世界中发生的药物不良事件,为该药的临床安全使用提供参考。方法 采用报告比值比法和比例报告比值法对FAERS数据库中2021年第1季度—2024年第2季度间以维立西呱为首要怀疑药物的不良事件数据进行挖掘,利用《国际医学用语词典》的系统器官分类(SOC)和首选术语(PT)对不良事件进行分类及描述,筛选出以上2种方法的共有不良事件信号进行分析。结果 获取得到维立西呱不良事件报告692例,报告对象以男性居多,年龄主要为50岁以上,报告国家或地区以美国、日本等为主,报告年份以2022、2023年为主,报告结局主要为死亡和住院。维立西呱信号挖掘得到11个SOC、23个PT信号。结论 本研究基于相关真实世界数据全面分析维立西呱上市后在实际临床应用中出现的不良事件特征,为临床用药安全和相关领域研究提供参考。

Objective To analyze the adverse drug events of vericiguat in the real world using FAERS database,and to provide reference for safe clinical medication.Methods The reporting odds ratio method and the proportional reporting ratio method were used to mine the adverse drug events data of vericiguat in the FAERS database from the first quarter of 2021 to the second quarter of 2024,with vericiguat as the primary suspected drugs.Classification and description of adverse drug events was conducted using the system organ class(SOC)and preferred term(PT)of the Medical Dictionary for Regulatory Activities.Common adverse drug events signals by above two methods were screened.Results A total of 692 cases of adverse drug events were obtained.Most patients were men,with the age of over 50 years old.The main sources of reported events were the United States and Japan.The reported events mainly occurred in 2022 and 2023.The main outcomes of reported events were death and hospitalization.Mining for vericiguat found that there were 11 SOCs and 23 PTs.Conclusion Based on the real-world data,this study comprehensively analyzed the adverse drug events characteristics in the actual clinical application of vericiguat,providing references for clinical use and related research.