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与双酸盐相关的眼部不良事件:基于FAERS数据库的药监测研究
Endocrine connections
|November 24, 2025
概括
双酸盐 (BPs) 可能导致严重的眼部不良事件 (AEs),包括炎症,白内障和绿内障. 这项研究确定了136种这些副作用的信号,其中许多未在药物标签上列出,突出了进一步安全研究的必要性.
科学领域:
- 药监和药物安全 药监和药物安全
- 眼科医生 眼科 眼科
- 骨质新陈代谢和治疗方法
背景情况:
- 双酸盐 (BPs) 广泛用于骨质疏松症和其他骨疾病.
- 眼部不良事件 (AEs) 曾经与双酸盐使用有关.
- 需要对与BP相关的眼部副作用进行全面的信号检测.
研究的目的:
- 识别和描述与双酸盐 (BP) 相关的眼部不良事件 (AE) 信号.
- 通过性别和年龄组调查眼睛AEs的潜在差异.
- 为未来关于BP使用的安全调查和临床实践提供信息.
主要方法:
- 对2004年第一季度至2024年第三季度的FDA不良事件报告系统 (FAERS) 数据的回顾性分析.
- 使用报告几率比率 (ROR),比例报告比率 (PRR) 和贝叶斯信任传播神经网络 (BCPNN) 的不成比例分析.
- 修改了ROR方法,以评估眼部AE的年龄和性别差异.
主要成果:
- 在5个BP的6965份报告中发现了136个积极的眼部AE信号,许多药物在当前的药物标签上没有列出.
- 值得注意的风险包括眼部炎症性AE (特别是zoledronate) 和新的信号,如白内障,绿内障和黄斑变性.
- 在所有五个BP中,质性障碍是常见的;在特定BP中观察到年龄和性别差异.
结论:
- 双酸盐与大量的眼部不良事件有关,包括炎症,白内障和绿内障等严重疾病.
- 鉴定到的眼部AE信号,特别是新的信号,需要进一步调查和对药物安全标签的潜在更新.
- 年龄和性别可能会影响双酸盐相关的眼部不良事件的风险概况.
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