与药物相关的黄斑胀:一个现实世界的FDA不良事件报告系统数据库研究研究
Xiang Li1,2, Yi-Qing Sun2, Qiong-Lian Huang3
1Eye Institute & Affiliated Xiamen Eye Center, School of Medicine, Xiamen University, Xiamen, Fujian, China.
BMC pharmacology & toxicology
|January 30, 2025
概括
这项研究确定了8种药物,包括Cefuroxime和Fingolimod,这些药物显著增加了药物诱导黄斑 (ME) 的风险. 这些发现有助于理解ME风险,并指导临床实践.
科学领域:
- 药物监督 药物监督 药物监督
- 眼科医生 眼科 眼科
- 药品安全 药品安全
背景情况:
- 黄斑 (ME) 可能是各种药物的严重副作用.
- 确定与药物诱导的ME相关的特定药物对于患者安全至关重要.
研究的目的:
- 评估药物诱导的黄斑胀 (ME) 的风险.
- 检查药物诱导的ME的流行病学特征.
- 识别具有诱导ME的积极信号的药物.
主要方法:
- 美国食品和药物管理局 (FDA) 的不良事件报告系统 (FAERS) 数据库的分析 (2004年1月 - 2024年6月).
- 不成比例性分析,以确定具有 ME 风险增加信号的药物.
- 检查与已识别的药物相关的ME发病时间.
主要成果:
- 在FAERS数据库中,共有490种药物与药物诱导的ME有关.
- 不成比例性分析发现8种药物具有诱发ME的显著风险.
- 鉴定出的关键药物包括塞福洛キシ姆 (ROR=75.93),芬戈利莫德 (ROR=30.69),西波尼莫德 (ROR=20.51) 和拉塔诺普罗斯特 (ROR=5.51).
结论:
- 在FAERS数据库是有价值的识别潜在的药物诱导的ME.
- 这项研究迅速确定了可能诱发ME的特定药物,包括眼科和非眼科药物.
- 这些发现支持改善临床药物指导和药监策略.
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