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每隔一天的干扰素β-1b与每周一次的干扰素β-1a用于多发性硬化症:为期2年的前性随机多中心研究 (INCOMIN) 的结果
Luca Durelli1, Elisabetta Verdun, Pierangelo Barbero
1Universita' di Torino, Torino, Italy
Lancet (London, England)
|May 4, 2002
概括
每隔一天服用高剂量的干扰素β-1b,与每周服用干扰素β-1a相比,在两年内在复发性复发性多发性硬化症患者中,在减少复发和新的MRI病变方面表现出更高的疗效.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
- 药理学 药理学 是一个学科.
背景情况:
- 多发性硬化症 (MS) 治疗涉及多种干扰素β (IFN-β) 制剂,使用不同的剂量表.
- 已批准的IFN-β疗法包括IFN-β-1a (30毫克每周或22/44毫克每周三次) 和IFN-β-1b (250毫克每隔一天).
- 这些不同的疗法之前缺乏直接比较的临床研究.
研究的目的:
- 为了比较两个不同的干扰素β方案的临床和磁共振成像 (MRI) 益处.
- 这项研究特别评估了每隔一天的干扰素β-1b (250毫克) 与每周一次的干扰素β-1a (30毫克) 相比.
主要方法:
- 进行了一项为期2年的前性随机多中心研究 (INCOMIN).
- 188名患有复发性复发性多发性硬化症的患者随机分配给接受干扰素β-1b (n=96) 或干扰素β-1a (n=92).
- 主要结局包括没有复发和没有新的MRI病变 (质子密度/T2) 的患者比例;进行了治疗意图分析.
主要成果:
- 在2年内,51%的干扰素β-1b接受者没有复发,而干扰素β-1a接受者只有36% (p=0.03).
- 在接受干扰素β-1b的患者中,显著更多的患者在MRI上没有新的T2病变 (55%对26%,p<0.0003).
- 干扰素β-1b在二次结局方面也显示出优势,包括延迟确诊的疾病进展.
结论:
- 每隔一天服用高剂量的干扰素β-1b比每周服用一次的干扰素β-1a更有效地治疗复发性复发性MS.
- 观察到的有利于干扰素β-1b的差异在治疗的第二年变得更加明显.
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