与TNF-α抑制剂相关的脱髓化疾病的全球负担:全球不成比例性分析
Tae Hyeon Kim1,2,3, Jaeyu Park2,3, Hyesu Jo2,4
1Department of Medicine, Kyung Hee University College of Medicine, Seoul, South Korea.
Medicine
|November 27, 2025
概括
这项研究发现,瘤亡因子-α (TNF-α) 抑制剂与多发性硬化症等脱髓化疾病之间存在显著联系. 临床医生应该在使用这些重要的疗法时监测患者的神经症状.
科学领域:
- 药监和流行病学 药监和流行病学
- 神经免疫学 神经免疫学
- 药品安全 药品安全
背景情况:
- 病例报告表明TNF-α抑制剂与脱髓化疾病之间存在联系.
- 支持这种关联的大规模流行病学数据有限.
- TNF-α 抑制剂广泛用于炎症和自身免疫性疾病.
研究的目的:
- 通过使用全球药监数据库,调查TNF-α抑制剂与脱髓化疾病之间的关联.
- 评估特定TNF-α抑制剂和脱髓化条件的信号检测.
- 为了告知临床警关于潜在的神经不良事件.
主要方法:
- 利用全球药监数据库 (1968-2024) 来识别不良事件报告.
- 包括五种TNF-α抑制剂:因弗利西玛布,阿达利穆马布,埃坦塞普特,克尔科利祖马布佩戈尔和戈利穆马布.
- 使用不成比例分析 (信息组件和报告几率比率) 进行信号检测.
主要成果:
- 确定了4124份与TNF-α抑制剂相关的脱髓化疾病报告.
- 证实了TNF-α抑制剂和脱髓化疾病之间的显著整体关联 (ROR 1.81).
- 多发性硬化症 (MS) 和吉兰-巴雷综合征 (GBS) 显示了与TNF-α抑制剂显著的信号检测.
结论:
- 大规模的药物监测证实TNF-α抑制剂与脱髓化疾病,特别是MS和GBS之间存在显著的关联.
- 在接受TNF-α抑制剂治疗的患者中,对神经症状的警至关重要.
- 作为TNF-α抑制剂的治疗益处可能会超过已确定的风险,因此需要仔细评估风险-益处关系.
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