Lillicrap Thomas P, Levi Christopher R, Holliday Elizabeth, Parsons Mark William, Bivard Andrew
Neurology Department, John Hunter Hospital, Newcastle, NSW, Australia.
Hunter Medical Research Institute, Newcastle, NSW, Australia.
Front Neurol. 2018 Apr 25;9:269. doi: 10.3389/fneur.2018.00269. eCollection 2018.
The phase-II modafinil in debilitating fatigue after stroke trial demonstrated that modafinil improves fatigue and quality of life in severely fatigued stroke survivors. For this study, we sought to examine the interaction between fatigue and quality of life after stroke and determine whether reducing fatigue resulted in improved quality of life. In addition, we followed up a subset of patients 12-months after the trial to assess the long-term outcomes of modafinil therapy.
We used linear regression to analyze interaction between baseline fatigue, as measured by the multidimensional fatigue inventory (MFI), and quality of life, as measured by the stroke-specific quality of life scale (SSQoL); and between changes in MFI and SSQoL during treatment. Patients also took part in semi-structured interviews and study assessments 12-months after trial completion to assess long-term patterns of modafinil use, safety and efficacy.
MFI and SSQoL were significantly correlated at baseline (β = -1.975 95% CI -3.082, -0.869, < 0.001), as were changes in MFI and SSQoL during treatment (β = -1.054 95% CI -1.556, -0.553, < 0.001). 18 patients agreed to 12-month follow-up, of whom 5 had continued to use modafinil. Patients taking modafinil daily demonstrated sustained improvement of 33-38 points in MFI compared to baseline. Two adverse events were reported and there was no evidence of drug tolerance.
Modafinil appears to be safe and, for at least some patients, effective long-term in fatigued stroke survivors. Alleviating fatigue has a significant relationship with improved quality of life.
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268, unique-identifier: ACTRN12615000350527.
二期莫达非尼治疗中风后衰弱性疲劳试验表明，莫达非尼可改善严重疲劳的中风幸存者的疲劳状况和生活质量。在本研究中，我们试图研究中风后疲劳与生活质量之间的相互作用，并确定减轻疲劳是否会改善生活质量。此外，我们在试验结束12个月后对一部分患者进行了随访，以评估莫达非尼治疗的长期效果。
我们使用线性回归分析通过多维疲劳量表（MFI）测量的基线疲劳与通过特定中风生活质量量表（SSQoL）测量的生活质量之间的相互作用；以及治疗期间MFI和SSQoL的变化之间的相互作用。患者在试验完成12个月后还参加了半结构化访谈和研究评估，以评估莫达非尼的长期使用模式、安全性和有效性。
基线时MFI和SSQoL显著相关（β=-1.975，95%CI -3.082，-0.869，P<0.001），治疗期间MFI和SSQoL的变化也显著相关（β=-1.054，95%CI -1.556，-0.553，P<0.001）。18名患者同意进行12个月的随访，其中5人继续使用莫达非尼。与基线相比，每天服用莫达非尼的患者MFI持续改善33 - 38分。报告了两起不良事件，没有药物耐受性的证据。
莫达非尼似乎对至少部分疲劳的中风幸存者长期而言是安全且有效的。减轻疲劳与改善生活质量有显著关系。
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268，唯一标识符：ACTRN12615000350527。
