背景:Relugolix已用于治疗晚期前列腺癌。这项研究评估了与美国食品和药物管理局不良事件报告系统(FAERS)的relugolix相关的不良事件(AE)。
方法:不成比例分析,包括报告赔率比(ROR),比例报告比率(PRR),贝叶斯置信度传播神经网络(BCPNN),和多项目伽马泊松收缩器(MGPS)算法,用于量化relugolix相关AE的信号。
结果:从FAERS数据库中收集了5,059,213份不良事件报告,其中5662例报告被确定为“主要嫌疑人(PS)”。同时保留了符合四种算法的总共70个显著的不相称性PT。意外的新AE,如勃起功能障碍,妇科乳房发育症,睾丸萎缩,男性生殖器萎缩,性欲下降也可能发生。
结论:这项研究发现了潜在的新AE信号,可能为relugolix的临床监测和风险识别提供重要支持。
BACKGROUND: Relugolix has been used to treat advanced prostate cancer. This study assessed adverse events (AEs) associated with
relugolix from the US Food and Drug Administration Adverse Event Reporting System (FAERS).
METHODS: Disproportionality analysis, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms, were employed to quantify the signals of
relugolix-associated AEs.
RESULTS: A total of 5,059,213 reports of AEs were collected from the FAERS database, of which 5,662 reports were identified with
relugolix as the \"primary suspect (PS)\". A total of 70 significant disproportionality PTs conforming to the four algorithms were simultaneously retained. Unexpected new AEs, such as erectile dysfunction, gynaecomastia, testicular atrophy, male genital atrophy, libido decreased might also occur.
CONCLUSIONS: This study found potential new AEs signals and might provide important support for clinical monitoring and risk identification of
relugolix.