罗菲科西布或纳普罗森与安慰剂对阿尔茨海默病进展的影响:一项随机对照试验
Paul S Aisen1, Kimberly A Schafer, Michael Grundman
1Department of Neurology, Georgetown University Medical Center, Washington, DC 20057, USA. psa@georgetown.edu
JAMA
|June 5, 2003
概括
非类固醇抗炎药物 (NSAIDs),如纳普罗森和罗菲科西布,在一年内没有减缓阿尔茨海默病 (AD) 患者的认知衰退. 该研究发现,与安慰剂相比,认知功能没有显著差异.
科学领域:
- 神经科学是一个神经科学.
- 药理学 药理学是指药理学的学科.
- 临床医学 临床医学
背景情况:
- 炎症机制与阿尔茨海默病 (AD) 中的神经元损伤有关.
- 假设非类固醇抗炎药物 (NSAIDs) 可能因其抗炎性质而改变AD进展.
研究的目的:
- 评估选择性循环氧化酶 (COX) - 2 抑制剂 (罗菲科西布) 或传统非选择性NSAID (纳普罗森) 管理是否减缓轻度至中度AD患者的认知衰退.
- 评估这些NSAIDs在AD患者群体中的安全性和有效性.
主要方法:
- 一个多中心,随机,双盲,安慰剂对照试验,涉及351名参与者,患有轻度至中度的AD.
- 参与者每天接受罗菲科克西布 (25毫克),纳普罗森 (220毫克每天两次) 或安慰剂一年.
- 认知能力下降主要通过阿尔茨海默病评估量-认知 (ADAS-Cog) 分量得分的1年变化来衡量.
主要成果:
- 在一年后,纳普罗森和罗菲科西布都没有显示出与安慰剂相比减缓认知衰退 (ADAS-Cog分数) 的显著差异.
- 二次结果测量也显示,对于任何一个积极治疗组都没有一致的益处.
- 与安慰剂相比,在活性药物组中观察到疲劳,头,高血压和更严重的不良事件的发生率增加.
结论:
- 罗菲科西布和低剂量纳普罗森似乎不会减缓轻度至中度阿尔茨海默病患者的认知衰退.
- 这些发现不支持使用这些NSAIDs来修改AD认知衰退的过程.
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