基于FAERS数据库的维立西呱不良事件信号挖掘及高龄患者特征分析  

Signal mining of vericiguat-related adverse events and characteristic analysis of elderly patients based on FAERS database

作　　者：胡婕 姜秋[1] 毛凯丽 钟松阳[1] 孙华瑜[1] HU Jie;JIANG Qiu;MAO Kaili;ZHONG Songyang;SUN Huayu(Department of Pharmacy,Quzhou People's Hospital,Quzhou 324000,Zhejiang Province,China)

机构地区：[1]衢州市人民医院药学部,浙江衢州324000

出　　处：《药学前沿》2025年第2期311-317,共7页China Pharmacist

基　　金：衢州市科技计划项目(2023K141)。

摘　　要：目的本研究旨在通过美国食品药品监督管理局不良事件报告系统(FAERS)数据库,深入挖掘维立西呱的可疑不良事件信号,以期为临床实践提供潜在药物风险的预警。方法汇总2021年第1季度维立西呱上市至2024年第3季度的FAERS报告,筛选维立西呱作为首要怀疑(PS)的药品不良事件(ADE)报告,利用《监管活动医学词典》中的系统器官分类(SOC)和首选术语(PT)对ADE进行标准化,采用药物警戒领域通用的报告比值比法(ROR)和比例报告比值比法(PRR)进行风险信号挖掘。结果以维立西呱作为PS的ADE报告共计755例,其中75岁以上的高龄患者占比高达21.55%,且其上报的ADE适应症主要集中在慢性心力衰竭方面。通过ROR与PRR法计算,共发现127个阳性信号。按照SOC,心脏器官疾病类的不良事件术语信号最强;按照PT分类,低血压、头晕、贫血的发生率信号凸显,与药品说明书中的描述相吻合。在老龄患者群体中,贫血与肾功能衰竭的信号尤为突出。结论本文通过挖掘和分析FAERS数据库中的维立西呱ADE信号,与药物说明的记载基本一致,整体安全可控。低血压、头晕、贫血是阳性信号较为显著的不良事件,与既往临床研究结论基本保持一致。对≥75岁的老年人而言,贫血信号尤为明显,肾功能损害出现阳性信号,提示临床注意对老年人用药监护,进一步保证用药安全。Objective To identify potential adverse event signals associated with vericiguat through the Food and Drug Administration Adverse Event Reporting System(FAERS)database,and to provide early warning of potential drug risks for clinical practice.Methods The reports were aggregated from the first quarter of 2021,when vericiguat was introduced to the market,to the third quarter of 2024 in the FAERS database.Reports in which vericiguat was identified as the primary suspect(PS)drug for adverse drug events(ADEs)were selected.Adverse events were standardized using the system organ classes(SOC)and preferred terms(PT)from the Medical Dictionary for Regulatory Activities(MedDRA).The reporting odds ratio(ROR)method and the proportional reporting ratio(PRR)method,which were commonly employed in pharmacovigilance,were utilized for risk signal mining.Results A total of 755 ADE reports identified vericiguat as the PS drug.The elderly population aged 75 and above accounted for 21.55%.The indications for the reported ADEs were predominantly chronic heart failure.By calculating using ROR and PRR methods,127 positive signals were identified.According to SOC,the adverse event terms with stronger signals were primarily concentrated in the category of cardiac organ diseases.According to PT classification,the incidence of hypotension,dizziness,and anemia was prominent,which was consistent with the description in the drug label.Among the elderly patients,the signals for anemia and renal failure were particularly prominent.Conclusion This article explores and analyzes the ADE signals of vericiguat in the FAERS database,which is consistent with the drug description.It is overall safe and controllable.Hypotension,dizziness,and anemia are adverse events with significant positive signals,which are consistent with previous clinical research conclusions.For elderly people aged 75 and above,anemia signals are particularly evident,and positive signals appear in renal function impairment,indicating clinical attention to medication monitoring for th

关 键 词：维立西呱 不良事件 药物警戒 美国食品药品监督管理局不良事件报告系统 

分 类 号：R969.3[医药卫生—药理学]