尾炎和多发性硬化症疾病修饰疗法:FDA不良事件报告系统的不成比例分析
Alexandra Balshi1, Madelyn Esser1, John P Dempsey2
1Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Multiple sclerosis and related disorders
|March 5, 2026
概括
多发性硬化症 (MS) 疾病修饰疗法 (DMT) 与尾炎报告的增加有关. 接受这些治疗的患者应该了解这种常见的外科紧急情况的早期预警信号.
科学领域:
- 免疫学 免疫学 免疫学
- 神经学 神经学
- 药物监督 药物监督 药物监督
背景情况:
- 尾炎是一种常见的外科紧急情况,与免疫功能有关.
- 多发性硬化症 (MS) 疾病修饰疗法 (DMT) 和尾炎风险之间的关系尚未得到充分理解.
- 调查与MS治疗相关的潜在不良事件对于患者安全至关重要.
研究的目的:
- 确定特定的MS DMTs是否与更高的尾炎发病率相关.
- 分析现实世界的数据,寻找MS DMTs和尾炎之间的潜在安全信号.
- 量化与MS DMTs相关的尾炎风险.
主要方法:
- 利用了来自FDA不良事件报告系统 (FAERS) 的数据.
- 进行了药监分析,将MS DMTs与其他药物的尾炎报告进行比较.
- 计算报告概率比率,以评估不成比例的高报告率.
主要成果:
- 确定了965起与MS DMTs相关的尾炎病例.
- 综合分析显示,在MS DMTs (ROR,2.83;95% CI,2.63-3.06) 中,尾炎的报道显著更高.
- 包括ocrelizumab,ofatumumab,natalizumab,alemtuzumab, fumarates,cladribine和干扰素β在内的特定DMT显示出不成比例的高尾炎报告率.
结论:
- 使用DMT的MS患者可能面临尾炎的风险增加.
- 医疗保健提供者应建议多发性硬化症患者识别早期尾炎症状.
- 对于患有多发性硬化症的个体,如果他们出现潜在的尾炎预警症状,建议立即进行医疗评估.
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