对利普瑞林相关不良事件的全面评估:美国食品药品管理局不良事件报告系统的启示。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-31 DOI:10.1080/14740338.2024.2423680
Xiao Tang, Fuchun Zheng, Zifang Ma, Huilong Shen, Zhijun Yao
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引用次数: 0

摘要

背景:亮丙瑞林是一种促性腺激素释放激素激动剂,被广泛用于治疗激素相关疾病。本研究旨在通过研究美国食品药品管理局不良事件报告系统(FAERS)数据库中的不良事件报告,探讨和分析亮丙瑞林的安全性:本研究利用2004年第一季度至2024年第一季度的FAERS数据进行了回顾性药物警戒分析。按照系统器官类别和具体不良事件对与亮普瑞林相关的药物不良事件(ADEs)进行了识别和分类。采用比例报告率 (PRR)、报告几率比 (ROR)、贝叶斯置信度传播神经网络 (BCPNN) 和经验贝叶斯几何平均 (EBGM) 等统计方法检测安全信号:共有 63,928 例 ADE 报告涉及亮丙瑞林,其中 500 个首选术语和 25 个系统器官类别显示出明显的不相称性。值得注意的罕见ADE是先天性球海绵状肌萎缩症(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)和无细胞脑膜瘤(n = 3;ROR 46.73,PRR 46.73,IC 5.34,EBGM 40.5):大多数发现都在预料之中,但也出现了一些新的信号,如以前未报道过的滤泡性膀胱炎。进一步的研究对验证这些发现至关重要,这些发现对利普瑞林的临床监测和风险识别至关重要。
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Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system.

Background: 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.

Methods: 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.

Results: 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 (n = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (n = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (n = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).

Conclusion: 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.

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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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