Randomized, double-blind, placebo-controlled crossover trial of modafinil in the treatment of excessive daytime sleepiness in narcolepsy
Randomized, double-blind, placebo-controlled crossover trial of modafinil in the treatment of excessive daytime sleepiness in narcolepsy
复制标题
DOI：
10.1212/wnl.49.2.444
复制
发表时间：
1997-08-01
期刊：
影响因子：
9.9
通讯作者：
Murphy, WF
中科院分区：
文献类型：
--
作者：
Broughton, RJ;Fleming, JAE;Murphy, WF
75例符合发作性睡病国际诊断标准的患者参加了一项为期6周、3个阶段、随机、交叉、安慰剂对照试验。患者接受安慰剂、莫达非尼200 mg或莫达非尼400 mg分次给药（早晨和中午）。在基线和每2周结束时进行评价。与安慰剂相比，莫达非尼200和400 mg显著增加了清醒维持试验的平均睡眠潜伏期40%和54%，两种剂量之间无显著差异。莫达非尼，200和400毫克，也减少了白天睡眠发作和睡眠日志中记录的严重嗜睡的次数。通过埃普沃思嗜睡量表测量的入睡可能性在两种莫达非尼剂量水平下同样降低。对夜间睡眠的开始、维持或结构没有影响，对睡眠呼吸暂停或周期性腿部运动也没有任何影响。无论是剂量干扰患者的能力，午睡自愿在白天，也与他们的数量或质量的夜间睡眠。莫达非尼对血压正常或高血压患者的血压和心率均无影响。唯一显著的不良反应出现在400 mg剂量，与安慰剂或200 mg剂量相比，这与更多的恶心和更多的紧张有关。因此，每日剂量少至200 mg的莫达非尼是治疗发作性睡病患者日间过度嗜睡的有效且耐受性良好的药物。
Seventy-five patients meeting international diagnostic criteria for narcolepsy enrolled in a 6-week, three-period, randomized, crossover, placebo-controlled trial. Patients received placebo, modafinil 200 mg, or modafinil 400 mg in divided doses (morning and noon). Evaluations occurred at baseline and at the end of each 2-week period. Compared with placebo, modafinil 200 and 400 mg significantly increased the mean sleep latency on the Maintenance of Wakefulness Test by 40% and 54%, with no significant difference between the two doses. Modafinil, 200 and 400 mg, also reduced the combined number of daytime sleep episodes and periods of severe sleepiness noted in sleep logs. The likelihood of falling asleep as measured by the Epworth Sleepiness Scale was equally reduced by both modafinil dose levels. There were no effects on nocturnal sleep initiation, maintenance, or architecture, nor were there any effects on sleep apnea or periodic leg movements. Neither dose interfered with the patients' ability to nap voluntarily during the day nor with their quantity or quality of nocturnal sleep. Modafinil produced no changes in blood pressure or heart rate in either normotensive or hypertensive patients. The only significant adverse effects were seen at the 400-mg dose, which was associated with more nausea and more nervousness than either placebo or the 200-mg dose. As little as a 200-mg daily dose of modafinil is therefore an effective and well-tolerated treatment of excessive daytime somnolence in narcoleptic persons.