格拉蒂拉默酸盐对临床隔离综合征患者转化为临床确定的多发性硬化症的影响 (PreCISe研究):一个随机,双盲,安慰剂控制的随机试验
G Comi1, V Martinelli, M Rodegher
1Institute of Experimental Neurology, Department of Neurology, University Vita-Salute, Scientific Institute San Raffaele, Milan, Italy. g.comi@hsr.it
Lancet (London, England)
|October 10, 2009
概括
早期glatiramer酸盐治疗显著延迟了临床上确定的多发性硬化症在临床上隔离综合征的患者的发病. 这一发现为多发性硬化症早期干预提供了新的治疗策略.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
背景情况:
- 格拉蒂拉默酸盐已批准用于治疗复发性复发性多发性硬化症,减少复发和MRI监测的疾病活性.
- 这项研究调查了早期glatiramer酸盐治疗延迟临床确定的多发性硬化症发病的疗效.
研究的目的:
- 评估早期glatiramer酸盐治疗延迟转化为临床确定的多发性硬化症的疗效.
主要方法:
- 一个随机的双盲试验,涉及481名患有临床隔离综合征和MRI检测到的大脑病变的患者.
- 患者每天接受皮下格拉蒂拉默酸盐20毫克或安慰剂,长达36个月.
- 主要终点是临床确定多发性硬化症的时间,定义为第二次临床攻击.
主要成果:
- 与安慰剂相比,格拉蒂拉默酸盐可将患临床确定的多发性硬化症的风险降低45% (HR0.55,p=0.0005).
- 25%的患者转化为临床确定的疾病的时间延长了115% (安慰剂为336天,格拉提拉乙酸为722天).
- 常见的不良事件包括注射部位反应和注射后立即反应.
结论:
- 早期glatiramer酸盐治疗是有效的延迟转换到临床确定的多发性硬化症.
- 这支持其用于临床隔离综合症和MRI检测到的大脑病变的患者.
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