Krupp L B, Coyle P K, Doscher C, Miller A, Cross A H, Jandorf L, Halper J, Johnson B, Morgante L, Grimson R
Multiple Sclerosis Comprehensive Care Center, State University of New York (SUNY) at Stony Brook, USA.
Neurology. 1995 Nov;45(11):1956-61. doi: 10.1212/wnl.45.11.1956.
To determine the relative efficacy of amantadine, pemoline, and placebo in treatment of multiple sclerosis (MS)-related fatigue.
Fatigue is a complication of MS. Both pemoline and amantadine have been used to treat MS fatigue, but their relative efficacy is not known.
Amantadine, pemoline, and placebo were compared in a randomized, double-blind, placebo-controlled study using a parallel-group design. Ninety-three ambulatory MS patients completed the study. Primary outcome measures were the fatigue severity scale (FSS); the MS-specific fatigue scale (MS-FS); and subjective response determined by verbal self-report. Secondary outcome measures consisted of assessments of sleep, depression, and vitality. Repeated-measures analysis of variance with planned post-hoc contrasts and Fisher's exact test were used to compare treatment response.
Amantadine-treated patients showed a significantly greater reduction in fatigue, as measured by the MS-FS, than did patients treated with placebo (p = 0.04). By verbal report at the end of the study, 79% of patients treated with amantadine versus 52% treated with placebo and 32% treated with pemoline preferred drug therapy compared with no treatment (p = 0.03). No significant differences in any primary outcome measures were noted between pemoline and placebo. Neither amantadine nor pemoline affected sleep or depression relative to placebo.
Amantadine was significantly better than placebo in treating fatigue in MS patients, whereas pemoline was not. The benefit of amantadine was not due to changes in sleep, depression, or neurologic disability.
确定金刚烷胺、匹莫林和安慰剂治疗多发性硬化症（MS）相关疲劳的相对疗效。
疲劳是MS的一种并发症。匹莫林和金刚烷胺均已用于治疗MS疲劳，但其相对疗效尚不清楚。
采用平行组设计，在一项随机、双盲、安慰剂对照研究中比较金刚烷胺、匹莫林和安慰剂。93例能行走的MS患者完成了该研究。主要结局指标为疲劳严重程度量表（FSS）、MS特异性疲劳量表（MS-FS）以及通过口头自我报告确定的主观反应。次要结局指标包括对睡眠、抑郁和活力的评估。采用带有计划的事后对比的重复测量方差分析和Fisher精确检验来比较治疗反应。
通过MS-FS测量，金刚烷胺治疗的患者疲劳程度的降低显著大于安慰剂治疗的患者（p = 0.04）。在研究结束时通过口头报告，与未治疗相比，79%接受金刚烷胺治疗的患者、52%接受安慰剂治疗的患者以及32%接受匹莫林治疗的患者更倾向于药物治疗（p = 0.03）。匹莫林和安慰剂之间在任何主要结局指标上均未观察到显著差异。相对于安慰剂，金刚烷胺和匹莫林均未影响睡眠或抑郁。
在治疗MS患者的疲劳方面，金刚烷胺显著优于安慰剂，而匹莫林则不然。金刚烷胺的益处并非归因于睡眠（改善）、抑郁（缓解）或神经功能障碍（减轻）。
