莫达非尼治疗小儿麻痹后遗症疲劳：一项随机对照试验。

Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial.

作者信息

Vasconcelos O M, Prokhorenko O A, Salajegheh M K, Kelley K F, Livornese K, Olsen C H, Vo A H, Dalakas M C, Halstead L S, Jabbari B, Campbell W W

机构信息

Department of Neurology, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.

出版信息

Neurology. 2007 May 15;68(20):1680-6. doi: 10.1212/01.wnl.0000261912.53959.b4.

DOI:10.1212/01.wnl.0000261912.53959.b4

PMID:17502549

Abstract

OBJECTIVE

To determine if modafinil can improve fatigue in patients with post-polio syndrome.

METHODS

We used a randomized, placebo-controlled crossover trial. Intervention with modafinil (400 mg/day) and placebo occurred over 6-week periods. Primary endpoint (fatigue) was assessed using the Fatigue Severity Scale as the main outcome measure. Other measures included the Visual Analog Scale for Fatigue and the Fatigue Impact Scale. Secondary endpoint (health-related quality of life) was assessed using the 36-Item Short-Form. Analysis of variance for repeated measures was applied to assess treatment, period, and carryover effects.

RESULTS

Thirty-six patients were randomized, 33 of whom (mean age: 61 years) completed required interventions. Treatment with modafinil was safe and well-tolerated. After adjusting for periods and order effects, no difference was observed between treatments.

CONCLUSION

Based on the utilized measures of outcome modafinil was not superior to placebo in alleviating fatigue or improving quality of life in the studied post-polio syndrome population.

摘要

目的

确定莫达非尼是否能改善小儿麻痹后遗症患者的疲劳症状。

方法

我们采用了一项随机、安慰剂对照的交叉试验。莫达非尼（400毫克/天）和安慰剂的干预为期6周。主要终点（疲劳）使用疲劳严重程度量表作为主要结局指标进行评估。其他测量指标包括疲劳视觉模拟量表和疲劳影响量表。次要终点（健康相关生活质量）使用36项简明健康调查问卷进行评估。采用重复测量方差分析来评估治疗、时期和遗留效应。