在急性中风患者的神经保护中的甘氨酸抗剂:GAIN美洲:随机对照试验
R L Sacco1, J T DeRosa, E C Haley
1The Neurological Institute, Columbia University, 710 W 168th St, Room 547, New York, NY 10032, USA. rls1@columbia.edu
JAMA
|April 13, 2001
概括
对急性缺血性中风的神经保护药物Gavestinel在6小时内治疗的患者中没有改善功能结果. 这项研究发现,与安慰剂相比,恢复或生存没有显著的益处.
科学领域:
- 神经科学是一个神经科学.
- 药理学 药理学 是一个学科.
- 临床神经学 临床神经学
背景情况:
- 神经保护药物的开发旨在减轻缺血性中风后的脑损伤.
- 尽管对缺血级联进行了研究,但迄今为止还没有任何神经保护药物证明其临床疗效.
研究的目的:
- 为了评估加维斯丁尼尔的有效性,一个N-甲基-D-酸盐受体甘氨酸位点抗剂,作为急性缺血性中风的神经保护疗法.
- 该研究评估了在症状出现后6小时内服用gavestinel的疗效.
主要方法:
- 一项随机,双盲,安慰剂对照试验 (GAIN美洲) 涉及1367名在132个中心的缺血性中风患者.
- 患者接受了三天内静脉注射的gavestinel或安慰剂,在三个月后使用巴特尔指数评估功能结果.
- 分层包括年龄和最初的中风严重程度 (NIH中风量表).
主要成果:
- 与安慰剂 (P =.79) 相比,在三个月内,Gavestinel治疗没有导致功能结局的统计学上显著改善.
- 实现功能独立的患者比例 (巴特尔指数95-100) 在两组之间是相似的 (39%的加韦西尼尔与37%的安慰剂).
- 没有观察到生存或二次终点的显著差异,即使在接受复合组织类型等离子体激活剂的患者中也是如此.
结论:
- 在中风后长达6小时内服用的Gavestinel在3个月后没有改善功能结果.
- 该研究得出的结论是,根据评估的终点,加维斯丁尼尔不是急性缺血性中风的有效神经保护疗法.
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