目的 基于美国FDA不良事件报告系统(FARES)数据库中收录的不良事件数据,分析研究奥贝胆酸相关不良事件的风险信号,为临床安全用药提供参考。方法 收集2016年5月27日-2023年6月30日美国FARES数据库中奥贝胆酸相关的不良事件报告,提取报告数排名前50位不良事件报告,采用报告比值法(ROR)挖掘奥贝胆酸不良反应风险信号。结果 共收集奥贝胆酸相关不良事件报告数5 800例,不良事件报告数前5位依次为瘙痒、乏力、恶心、关节痛、死亡。对报告数排名前50位不良事件进行药物不良反应风险信号分析,检测出36个不良反应风险信号,主要累及胃肠系统(6个)、皮肤及皮下组织(5个)、生化检查(5个)、神经系统(4个)、肝胆系统(4个);发现了13个说明书中未记载的阳性信号,强度排名前5位的依次是药物漏用、腹胀、皮肤干燥、记忆损伤和失眠。结论 根据奥贝胆酸不良事件的真实世界数据系统、全面地分析了其潜在的不良反应风险,提示临床予以关注及进一步进行安全性评价,为有效开展药学监护和临床合理用药提供参考依据。

Objective To explore the adverse event of obeticholic acid based on FARES database, and provide guidance for clinical practice. Methods The obeticholic acid-related adverse event reports were collected in the FARES database from May 27, 2016 to June 30, 2023. The top 50 adverse event reports were extracted. Reporting odds ratio (ROR) was utilized for signal detection of adverse drug reaction. Results A total of 5 800 adverse event reports with obeticholic acid as a primary suspicious drug were retrieved from the FARES database. The top 5 adverse events were pruritus, fatigue, nausea, arthralgia, and death. The top 50 reported adverse events were analyzed for adverse reaction risk signals, and 36 adverse reaction risk signals were detected, mainly involving gastrointestinal system (6), skin and subcutaneous tissue (5), biochemical examination (5), nervous system (4), hepatobiliary system (4), etc. Thirteen adverse events uncovered by the label were screened out, and the top 5 new adverse event risk signals were missed medication, abdominal distension, dry skin, memory impairment, and insomnia. Conclusions According to the real world data of adverse events of obecholic acid, the potential risk of adverse reactions was analyzed comprehensively, which suggested clinical attention and further safety evaluation, and provided a reference for effective pharmaceutical care and clinical rational drug use.

R975

北京市研究型病房建设示范单位项目(BCRW202010)