Becker Philip M, Schwartz Jonathan R L, Feldman Neil T, Hughes Rod J
Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Tex., USA.
Psychopharmacology (Berl). 2004 Jan;171(2):133-9. doi: 10.1007/s00213-003-1508-9. Epub 2003 Nov 25.
In addition to excessive sleepiness, patients with narcolepsy often have significant fatigue, depressed mood, and decreased quality of life.
To determine whether treatment with modafinil for excessive sleepiness improves fatigue, mood, and health-related quality of life (HRQOL) in patients with narcolepsy.
Outpatients with narcolepsy underwent a 14-day washout of psychostimulants and then were enrolled in this 6-week, open-label, multicenter study. Patients received modafinil starting at 200 mg once daily for week 1, and then 200 or 400 mg daily for weeks 2 through 6. Efficacy was evaluated using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the Profile of Mood States (POMS). Safety was assessed by monitoring adverse events (AE).
At baseline, 151 patients had moderate to severe excessive sleepiness (mean Epworth Sleepiness Scale score=17.8+/-4.4). Most patients (> or =70% of 123 who completed the study) received 400 mg modafinil once daily during weeks 2 through 6. Modafinil significantly improved HRQOL, based on SF-36 measures of mental and physical component summary scores and subdomain scores of role-physical, social functioning, and vitality (each P<0.001). Modafinil treatment was also associated with significantly reduced fatigue and significantly improved vigor and cognition as assessed by the POMS (each P<0.001) from weeks 1 through 6. The most frequent AE with modafinil treatment were headache, nausea, and insomnia; most AE were mild or moderate in nature. Only seven patients (5%) withdrew from the study because of AE.
In narcolepsy patients who were switched from psychostimulants, modafinil therapy improved HRQOL and subjective feelings of vigor and cognitive functioning and reduced fatigue.
发作性睡病患者除了过度嗜睡外，还常常伴有明显的疲劳、情绪低落和生活质量下降。
确定莫达非尼治疗过度嗜睡是否能改善发作性睡病患者的疲劳、情绪及健康相关生活质量（HRQOL）。
发作性睡病门诊患者停用精神兴奋剂14天，然后参加这项为期6周的开放标签多中心研究。患者第1周开始服用莫达非尼，每日一次，每次200mg，第2至6周每日服用200或400mg。使用医学结局研究36项简短健康调查（SF-36）和情绪状态量表（POMS）评估疗效。通过监测不良事件（AE）评估安全性。
基线时，151例患者有中度至重度过度嗜睡（平均爱泼沃斯嗜睡量表评分为17.8±4.4）。大多数患者（完成研究的123例患者中≥70%）在第2至6周期间每日服用一次400mg莫达非尼。基于SF-36的心理和身体综合评分以及角色-身体、社会功能和活力子领域评分，莫达非尼显著改善了HRQOL（每项P<0.001）。从第1至6周，通过POMS评估，莫达非尼治疗还与疲劳显著减轻、活力和认知显著改善相关（每项P<0.001）。莫达非尼治疗最常见的不良事件是头痛、恶心和失眠；大多数不良事件为轻度或中度。只有7例患者（5%）因不良事件退出研究。
在从精神兴奋剂转换治疗的发作性睡病患者中，莫达非尼治疗改善了HRQOL、主观活力感和认知功能，并减轻了疲劳。
