基于FAERS数据库对利奥西呱不良事件信号挖掘和分析

Mining and Analysis of Riociguat-related Adverse Drug Events Based on FAERS Database

目的挖掘并分析利奥西呱相关不良事件(Adverse Drug Events,ADE)的风险信号,为临床合理用药提供参考。方法收集美国食品药品监督管理局不良反应事件报告系统(FDA adverse event reporting system,FAERS)数据库2013年第四季度到2022年第三季度的ADE报告,采用报告比值比(ROR)和比例报告比值比(PRR)对ADE进行挖掘。结果共提取到以利奥西呱为首要怀疑药品的ADE报告数7512份。年龄分布主要集中在45岁以上(5384例,71.67%),其中65岁及以上老年人较为多见,男女比例为0.44。共检测到232个ADE阳性信号,涉及20个系统和器官。其中胃肠系统疾病ADE报告数最多(2903例次),共检出信号数42个,随后依次为呼吸系统、胸及纵隔疾病,各类检查,全身性疾病及给药部位各种反应,各类损伤、中毒及操作并发症等。发生频次较高的不良事件基本与说明书保持一致。说明书未收录的不良反应包括液体潴留、心力衰竭、呼吸困难、晕厥等。结论通过FAERS数据库中利奥西呱不良事件进行挖掘和分析,除说明书的不良反应外,应密切关注说明书之外的ADE,以保证患者用药的安全性和有效性。

OBJECTIVE To mine and analyse the risk signal of riociguat related ADE,and provide reference for rational use of drug.METHODS Collected ADE reports from the database which is from the fourth quarter of 2013 to the third quarter of 2022 in US Food and Drug Administration Adverse Event Reporting System(FAERS).Reporting odds ratio(ROR)method and proportional reporting ratio(PRR)method were used to mine and analyse the riociguat ADE.RESULTS 7512 ADE reports of riociguat were detected as the primary suspected drug,which mainly focus on the age over 45 years old(5384 cases,71.67%),mainly happened in the olds over 65 years old,male to female ratio was 0.44.There were 232 ADE positive signals detected,which involved twenty system and organ classifications.The most ADE reports were about Gastrointestinal disorders(2903 cases),followed by respiratory,thoracic and mediastinal disorders;investigations;general disorders and administration site conditions;injury,poisoning and procedural complications.The frequency of adverse event signals was generally consistent with the drug instructions.Fluid retention,heart failure,dyspnea,syncope,etc not included in the drug instructions.CONCLUSION By mining and analyzing of ADE from the FAERS database,in addition to the adverse events in the brochures,ADE outside the brochures should be closely monitored to ensure the safety and efficacy of medication for patients.