Poulsen Mai Bang, Damgaard Bodil, Zerahn Bo, Overgaard Karsten, Rasmussen Rune Skovgaard
Departments of Neurology (M.B.P., K.O., R.S.R.), Radiology (B.D.), and Clinical Physiology (B.Z.), Herlev University Hospital, Herlev, Denmark; and Department of Radiology, Hilleroed University Hospital, Hilleroed, Denmark (B.D.).
Stroke. 2015 Dec;46(12):3470-7. doi: 10.1161/STROKEAHA.115.010860. Epub 2015 Nov 3.
Poststroke fatigue is common and reduces quality of life. Current evidence for intervention is limited, and this is the first placebo-controlled trial to investigate treatment of poststroke fatigue with the wakefulness promoting drug modafinil.
The trial was randomized, double-blinded, and placebo-controlled. Patients were treated with 400-mg modafinil or placebo for 90 days. Assessments were done at inclusion, 30, 90, and 180 days. The primary end point was fatigue at 90 days measured by the Multidimensional Fatigue Inventory-20 general fatigue domain. Secondary end points included the Fatigue Severity Scale, the Montreal Cognitive Assessment, the modified Rankin Scale and the Stroke-specific quality of Life questionnaire. Adult patients with a recent stroke achieving a score of ≥12 on the Multidimensional Fatigue Inventory-20 general fatigue domain were consecutively included. Exclusion criteria were severe cognitive disabilities and contraindications for modafinil treatment.
One thousand one hundred twenty-one patients with stroke were screened and 41 patients included, 21 received modafinil. The primary end point, the Multidimensional Fatigue Inventory-20 general fatigue score, did not differ between groups. Patients in the modafinil group obtained better scores on the Fatigue Severity Scale (P=0.02) and in some subscales of the stroke-specific quality of life questionnaire (0.001<P<0.05), which were secondary outcomes. No serious adverse reactions were observed and there was no difference in blood pressure between groups.
There were no significant differences between the 2 groups with regard to the primary end point. There were secondary significant outcomes that should be explored in future trials.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01800097.
中风后疲劳很常见，会降低生活质量。目前干预措施的证据有限，这是第一项使用促觉醒药物莫达非尼治疗中风后疲劳的安慰剂对照试验。
该试验为随机、双盲、安慰剂对照试验。患者接受400毫克莫达非尼或安慰剂治疗90天。在纳入时、30天、90天和180天进行评估。主要终点是90天时通过多维疲劳量表-20一般疲劳领域测量的疲劳程度。次要终点包括疲劳严重程度量表、蒙特利尔认知评估、改良Rankin量表和中风特异性生活质量问卷。连续纳入近期中风且在多维疲劳量表-20一般疲劳领域得分≥12分的成年患者。排除标准为严重认知障碍和莫达非尼治疗的禁忌症。
筛查了1121名中风患者，纳入41名患者，21名接受莫达非尼治疗。两组之间的主要终点，即多维疲劳量表-20一般疲劳得分没有差异。莫达非尼组患者在疲劳严重程度量表（P=0.02）和中风特异性生活质量问卷的一些子量表（0.001<P<0.05）上得分更高，这些是次要结果。未观察到严重不良反应，两组之间血压无差异。
两组在主要终点方面无显著差异。有一些次要显著结果值得在未来试验中进一步探索。
