FATIGUE THERAPY IN MULTIPLE-SCLEROSIS - RESULTS OF A DOUBLE-BLIND, RANDOMIZED, PARALLEL TRIAL OF AMANTADINE, PEMOLINE, AND PLACEBO
FATIGUE THERAPY IN MULTIPLE-SCLEROSIS - RESULTS OF A DOUBLE-BLIND, RANDOMIZED, PARALLEL TRIAL OF AMANTADINE, PEMOLINE, AND PLACEBO
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DOI：
10.1212/wnl.45.11.1956
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发表时间：
1995-11-01
期刊：
影响因子：
9.9
通讯作者：
GRIMSON, R
中科院分区：
文献类型：
--
作者：
KRUPP, LB;COYLE, PK;GRIMSON, R
目的：探讨金刚烷胺、培莫林和安慰剂治疗多发性硬化症（MS）相关性疲劳的相对疗效。背景：疲劳是多发性硬化症的并发症。pemoline和金刚烷胺已被用于治疗多发性硬化症疲劳，但其相对疗效尚不清楚。方法：采用平行组设计，在随机、双盲、安慰剂对照研究中比较金刚烷胺、培莫林和安慰剂。93名MS患者完成了这项研究。主要观察指标为疲劳严重程度量表（FSS）；MS-FS疲劳量表；主观反应由口头自我报告决定。次要结局指标包括睡眠、抑郁和活力的评估。使用计划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。结果：经MS-FS测量，金刚烷胺治疗的患者比安慰剂治疗的患者表现出明显更大的疲劳减轻（p = 0.04）。通过研究结束时的口头报告，79%的患者接受金刚烷胺治疗，52%的患者接受安慰剂治疗，32%的患者接受佩莫林首选药物治疗，与未接受治疗的患者相比（p = 0.03）。培莫林和安慰剂在任何主要结局指标上均无显著差异。与安慰剂相比，金刚烷胺和派莫林对睡眠和抑郁都没有影响。结论：金刚烷胺对多发性硬化症患者疲劳的治疗效果明显优于安慰剂，而哌替啶的治疗效果不明显。金刚烷胺的益处不是由于睡眠、抑郁或神经功能障碍的改变。
Objective: To determine the relative efficacy of amantadine, pemoline, and placebo in treatment of multiple sclerosis (MS)-related fatigue. Background: Fatigue is a complication of MS. Both pemoline and amantadine have been used to treat MS fatigue, but their relative efficacy is not known. Methods: 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. Results: 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. Conclusion: 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.