在FDA不良事件报告系统 (FAERS) 数据库中对Ozanimod的真实数据分析
Qinhui Tang1,2, Xiaowei Tang1,2, Xinyue Hu1,2
1Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.
Medicine
|September 17, 2025
概括
用于多发性硬化症和性结肠炎的ozanimod显示出各种不良反应的潜力. 早期检测和预防低血压和肌肉等副作用对于患者的安全至关重要.
科学领域:
- 药监和药物安全 药监和药物安全
- 临床药理学 临床药理学
- 神经学和胃肠道学.
背景情况:
- 奥萨尼莫德已批准用于复发性多发性硬化症 (MS) 和性结肠炎 (UC).
- 有限的市场后安全数据存在于Ozanimod.
- 了解药物不良事件 (ADEs) 对于安全的临床使用至关重要.
研究的目的:
- 调查Ozanimod在市场上市后的安全性.
- 为了识别与Ozanimod使用相关的潜在安全信号和不良反应.
- 为了与临床试验数据比较市场后观察到的不良反应.
主要方法:
- 使用了美国食品和药物管理局不良事件报告系统 (FAERS) 数据库.
- 分析了5,429份报告,其中Ozanimod是主要的可疑药物.
- 使用四种不成比例分析算法 (ROR,PRR,BCNN,MGPS) 来检测安全信号.
主要成果:
- 在26个器官系统中确定了90个首选术语,满足了所有四个算法标准.
- 观察到的ADEs与临床试验一致 (例如,背痛,高血压,肝酶升高).
- 检测到未在药物标签上显示的新安全信号,包括低血压,肌肉,平衡障碍和步行障碍.
结论:
- 奥扎尼莫德与临床试验之外的一系列不良反应有关.
- 大多数ADE发生在治疗开始后的30天内.
- 强调需要在临床实践中对Ozanimod相关不良事件进行警监测和及时管理.
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