流动神经介导的神经免疫调节用于类风湿性关节炎:一个关键的随机对照试验
John R P Tesser1, Angela R Crowley2, Emily Jane Box3
1Arizona Arthritis & Rheumatology Research, Avondale, AZ, USA.
Nature medicine
|December 22, 2025
概括
一种针对迷走神经的新型神经调节系统在治疗类风湿性关节炎 (RA) 中表现出显著的疗效. 这种方法实现了其主要终点,为RA患者提供了持久的临床益处和有利的安全概况.
科学领域:
- 神经免疫学 神经免疫学
- 类风湿病学 类风湿病学
- 医疗器械 医疗器械
背景情况:
- 炎症反射,涉及迷走神经信号传递和细胞因子生产,在类风湿性关节炎 (RA) 中被破坏.
- 对于一些患者来说,RA的现有治疗方法可能不足,需要新的治疗策略.
研究的目的:
- 评估一套针对流动神经的神经调节系统在风湿性关节炎患者中的疗效和安全性.
- 评估迷走神经刺激对RA症状和疾病活动的影响.
主要方法:
- 一个双盲,随机化,假控制试验 (RESET-RA) 涉及242名RA患者,对标准疗法反应不足.
- 患者接受了3个月的活跃或假的迷走神经刺激,随后接受了长达12个月的开放式活跃刺激.
- 主要疗效终点是美国风湿病学学院3个月后20% (ACR20) 的反应.
主要成果:
- 活跃的迷走神经刺激显示显著更高的ACR20响应率比假的3个月 (35.2%对24.2%,P=0.0209).
- 观察到持续的改善,ACR20率在6个月后达到50.0%,在12个月后达到52.8%.
- 两组间的不良事件是相似的,严重的不良事件很少发生 (1.6%) 主要是术后.
结论:
- 迷你神经神经调节有效地实现了其对类风湿性关节炎的主要疗效终点.
- 该疗法证明了持久的临床益处和有利的安全性,这表明了对RA的有希望的新治疗途径.
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