Schwartz Jonathan R L, Feldman Neil T, Bogan Richard K, Nelson Michael T, Hughes Rod J
Integris Sleep Disorders Center of Oklahoma, Integris Southwest and Baptist Medical Centers, 4200 S. Douglas Avenue, Suite 313, Oklahoma City, OK 73109, USA.
Clin Neuropharmacol. 2003 Sep-Oct;26(5):252-7. doi: 10.1097/00002826-200309000-00009.
In a multicenter, randomized, double-blind study the authors compared the efficacy of modafinil 400 mg once daily, 400 mg given in a split dose, or 200 mg once daily for maintaining wakefulness throughout the day in patients (N = 32) with narcolepsy reporting a positive daytime response to modafinil but late-afternoon/evening sleepiness. Efficacy evaluations included an extended Maintenance of Wakefulness Test (9:00 am to 9:00 pm), the Clinical Global Impression of Change scale, and the Epworth Sleepiness Scale. Modafinil demonstrated significant improvement in wakefulness as assessed by the Epworth Sleepiness Scale compared with placebo at baseline (all P < 0.001). Modafinil significantly improved patients' ability to sustain wakefulness, as demonstrated by mean sleep latency at week 3 compared with placebo at baseline (all P < 0.001). The 400-mg split-dose regimen improved wakefulness significantly in the evening compared with the 200-mg and 400-mg once-daily regimen (both P < 0.05). The percentage of patients rated as "much improved" or "very much improved" with respect to evening sleepiness was 27%, 82%, and 80% in the 200-mg, 400-mg once-daily, and 400-mg split-dose groups, respectively. Adverse events were mild to moderate in nature and included headache, nausea, nervousness, dyspepsia, pain, and vomiting (all 6%). Some patients may benefit from 400-mg doses of modafinil taken once daily compared with 200-mg doses. A split-dose 400-mg regimen may be superior to once-daily dosing for sustaining wakefulness throughout the entire waking day.
在一项多中心、随机、双盲研究中，作者比较了每日一次服用400毫克莫达非尼、分剂量服用400毫克或每日一次服用200毫克对发作性睡病患者（N = 32）全天维持清醒的疗效，这些患者报告称白天对莫达非尼有积极反应，但下午晚些时候/晚上会感到困倦。疗效评估包括延长的清醒维持测试（上午9点至晚上9点）、临床总体印象变化量表和爱泼华嗜睡量表。与基线时的安慰剂相比，通过爱泼华嗜睡量表评估，莫达非尼在清醒方面有显著改善（所有P < 0.001）。与基线时的安慰剂相比，第3周的平均睡眠潜伏期表明，莫达非尼显著提高了患者维持清醒的能力（所有P < 0.001）。与200毫克和400毫克每日一次的给药方案相比，400毫克分剂量给药方案在晚上能显著改善清醒状态（两者P < 0.05）。在200毫克、400毫克每日一次和400毫克分剂量组中，被评为晚上困倦“有很大改善”或“非常有很大改善”的患者百分比分别为27%、82%和80%。不良事件性质为轻度至中度，包括头痛、恶心、紧张、消化不良、疼痛和呕吐（均为6%）。与200毫克剂量相比，一些患者可能从每日一次服用400毫克剂量的莫达非尼中获益。对于在整个清醒日维持清醒，400毫克分剂量给药方案可能优于每日一次给药。
