Tang Xiao, Zheng Fuchun, Ma Zifang, Shen Huilong, Yao Zhijun
Department of Urology, Hengyang Central Hospital, Affiliated Hengyang Hospital of Hunan Normal University, Hengyang, Hunan, China.
Department of Urology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China.
Expert Opin Drug Saf. 2025 Mar;24(3):355-364. doi: 10.1080/14740338.2024.2423680. Epub 2024 Oct 31.
Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.
This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals.
A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital ( = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis ( = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma ( = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).
Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.
亮丙瑞林是一种促性腺激素释放激素激动剂，广泛用于治疗激素相关疾病。本研究旨在通过检查美国食品药品监督管理局不良事件报告系统（FAERS）数据库中的不良事件报告，探索和分析亮丙瑞林的安全性概况。
本研究使用2004年第一季度至2024年第一季度的FAERS数据进行回顾性药物警戒分析。识别与亮丙瑞林相关的药物不良事件（ADEs），并按系统器官类别和特定不良事件进行分类。使用比例报告比值（PRR）、报告比值比（ROR）、贝叶斯置信传播神经网络（BCPNN）和经验贝叶斯几何均值（EBGM）等统计方法来检测安全信号。
共有63928份ADE报告涉及亮丙瑞林，500个首选术语和25个系统器官类别显示出显著的不成比例。识别出的显著罕见ADEs包括先天性延髓脊髓性肌萎缩（n = 26；ROR 1282.72，PRR 1282.52，IC 7.91，EBGM 241.28）、滤泡性膀胱炎（n = 3；ROR 126.84，PRR 126.84，IC 6.48，EBGM 89.09）和间变性脑膜瘤（n = 3；ROR 46.73，PRR 46.73，IC 5.34，EBGM 40.5）。
大多数发现是预期的，但出现了如滤泡性膀胱炎等以前未报告的新信号。进一步的研究对于验证这些发现至关重要，这对于亮丙瑞林的临床监测和风险识别至关重要。
