基于FAERS数据库的瑞美吉泮不良事件信号挖掘与分析

Signal mining and analysis of rimegepant adverse events based on FAERS database

目的 挖掘瑞美吉泮的风险信号,为临床安全合理用药提供参考。方法 收集FAERS数据库2020年1月1日—2024年3月31日的瑞美吉泮相关不良事件报告数据。采用比例失衡法中的ROR法和BCPNN法进行数据挖掘,利用药物不良反应术语集的首选系统器官分类和首选术语对挖掘到的风险信号进行分类和描述。结果 共提取以瑞美吉泮为首要怀疑药物的不良事件报告10 550份,排除缺失数据,共有男性患者965份(占比9.15%),女性患者6 710份(占比63.60%)。经筛选共获得阳性信号38个,发生报告数较多的系统器官为胃肠系统疾病、各类神经系统疾病和全身性疾病及给药部位各种反应;信号强度较强的新的不良事件主要有治疗产品效果不稳、赋形剂反应、舌不适、晨吐、醉酒感和鼻水肿等。结论 瑞美吉泮在真实世界中发生的常见不良反应与说明书有一致性,但存在较多新的、可疑的、未载入说明书的不良反应,临床用药时应予以重点关注,以保障患者用药安全。

Objective To explore the risk signals of rimegepant,and provide reference for clinical rational and safe drug use.Methods Adverse drug event report data related to rimegepant from January 1,2020 to March 31,2024 were collected from the FAERS database.The ROR and BCPNN methods of the proportional imbalance method were used for data mining,and the preferred system organ classification and preferred terminology of the Adverse Drug Reaction Terminology Set were utilized to classify and describe the mined risk signals.Results A total of 10550 adverse event reports were extracted with rimegepant as the first suspected drug,excluding missing data,there were a total of 965(9.15%)male patients and 6710(63.60%)female patients.A total of 38 positive signals were obtained after screening,and the systemic organs where more reports occurred were gastrointestinal disorders,various neurological disorders and systemic disorders,and various reactions at the site of administration,the main new adverse events with a strong signal strength were instability of therapeutic product effect,excipient reaction,tongue discomfort,morning sickness,intoxication sensation,and nasal edema.Conclusion The common adverse reactions occurring in the real world with rimegepant are consistent with the specification,but there are more new,suspicious,and not contained in the specification of the adverse reactions,the clinical use of the drug should be focused on to protect the safety of patients using the drug.