目的 基于美國FDA不良事件報告系統(tǒng)(FARES)數(shù)據(jù)庫中收錄的不良事件數(shù)據(jù),分析研究奧貝膽酸相關不良事件的風險信號,為臨床安全用藥提供參考。方法 收集2016年5月27日-2023年6月30日美國FARES數(shù)據(jù)庫中奧貝膽酸相關的不良事件報告,提取報告數(shù)排名前50位不良事件報告,采用報告比值法(ROR)挖掘奧貝膽酸不良反應風險信號。結果 共收集奧貝膽酸相關不良事件報告數(shù)5 800例,不良事件報告數(shù)前5位依次為瘙癢、乏力、惡心、關節(jié)痛、死亡。對報告數(shù)排名前50位不良事件進行藥物不良反應風險信號分析,檢測出36個不良反應風險信號,主要累及胃腸系統(tǒng)(6個)、皮膚及皮下組織(5個)、生化檢查(5個)、神經(jīng)系統(tǒng)(4個)、肝膽系統(tǒng)(4個);發(fā)現(xiàn)了13個說明書中未記載的陽性信號,強度排名前5位的依次是藥物漏用、腹脹、皮膚干燥、記憶損傷和失眠。結論 根據(jù)奧貝膽酸不良事件的真實世界數(shù)據(jù)系統(tǒng)、全面地分析了其潛在的不良反應風險,提示臨床予以關注及進一步進行安全性評價,為有效開展藥學監(jiān)護和臨床合理用藥提供參考依據(jù)。

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設示范單位項目(BCRW202010)