米达斯（莫达非尼治疗中风后衰弱性疲劳）：一项随机、双盲、安慰剂对照的交叉试验。
MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial.
作者信息
Bivard Andrew, Lillicrap Thomas, Krishnamurthy Venkatesh, Holliday Elizabeth, Attia John, Pagram Heather, Nilsson Michael, Parsons Mark, Levi Christopher R
机构信息
From the Departments of Neurology, John Hunter Hospital (A.B., T.L., V.K., M.P., C.R.L.), Hunter Medical Research Institute (A.B., T.L., V.K., E.H., J.A., H.P., M.N., M.P., C.R.L.), and Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health (J.A.), University of Newcastle, Australia.
出版信息
Stroke. 2017 May;48(5):1293-1298. doi: 10.1161/STROKEAHA.116.016293. Epub 2017 Apr 12.
BACKGROUND AND PURPOSE
This study aimed to assess the efficacy of modafinil, a wakefulness-promoting agent in alleviating post-stroke fatigue ≥3 months after stroke. We hypothesized that 200 mg of modafinil daily for 6 weeks would result in reduced symptoms of fatigue compared with placebo.
METHODS
This single-center phase 2 trial used a randomized, double-blind, placebo-controlled, crossover design. The key inclusion criterion was a multidimensional fatigue inventory score of ≥60. Patients were randomized to either modafinil or placebo for 6 weeks of therapy, then after a 1 week washout period swapped treatment arms for a second 6 weeks of therapy. The primary outcome was the multidimensional fatigue inventory; secondary outcomes included the Montreal cognitive assessment, the Depression, Anxiety, and Stress Scale (DASS), and the Stroke-Specific Quality of Life (SSQoL) scale. The multidimensional fatigue inventory is a self-administered questionnaire with a range of 0 to 100. Treatment efficacy was assessed using linear regression by estimating within-person, baseline-adjusted differences in mean outcomes after therapy. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000350527).
RESULTS
A total of 232 stroke survivors were screened and 36 were randomized. Participants receiving modafinil reported a significant decrease in fatigue (multidimensional fatigue inventory, -7.38; 95% CI, -21.76 to -2.99; <0.001) and improved quality of life (SSQoL, 11.81; 95% CI, 2.31 to 21.31; =0.0148) compared with placebo. Montreal cognitive assessment and DASS were not significantly improved with modafinil therapy during the study period (>0.05).
CONCLUSIONS
Stroke survivors with nonresolving fatigue reported reduced fatigue and improved quality of life after taking 200 mg daily treatment with modafinil.
CLINICAL TRIAL REGISTRATION
URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268. Unique identifier: ACTRN12615000350527.
背景与目的
本研究旨在评估促觉醒药物莫达非尼对卒中后≥3个月的疲劳症状的缓解效果。我们假设，与安慰剂相比，每日服用200毫克莫达非尼，持续6周，将减轻疲劳症状。
方法
本单中心2期试验采用随机、双盲、安慰剂对照、交叉设计。关键纳入标准是多维疲劳量表评分≥60分。患者被随机分为莫达非尼组或安慰剂组，接受6周治疗，然后在1周的洗脱期后，交换治疗组，再进行6周治疗。主要结局指标是多维疲劳量表；次要结局指标包括蒙特利尔认知评估、抑郁、焦虑和压力量表（DASS）以及卒中特异性生活质量（SSQoL）量表。多维疲劳量表是一份自我填写的问卷，范围为0至100分。通过估计治疗后个体内、基线调整后的平均结局差异，采用线性回归评估治疗效果。本试验已在澳大利亚新西兰临床试验注册中心注册（ACTRN12615000350527）。
结果
共筛选了232名卒中幸存者，36名被随机分组。与安慰剂相比，接受莫达非尼治疗者报告疲劳症状显著减轻（多维疲劳量表，-7.38；95%CI，-21.76至-2.99；<0.001），生活质量得到改善（SSQoL，11.81；95%CI，2.31至21.31；=0.0148）。在研究期间，莫达非尼治疗对蒙特利尔认知评估和DASS无显著改善（>0.05）。
结论
疲劳症状持续未缓解的卒中幸存者在每日服用200毫克莫达非尼治疗后，疲劳症状减轻，生活质量改善。
临床试验注册
网址：https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268。唯一标识符：ACTRN12615000350527。
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