Department of Pharmacoeconomics, Medical University of Warsaw, Warsaw, Poland.
Med Sci Monit. 2010 Aug;16(8):RA177-86.
To assess the effectiveness and safety of modafinil vs. no active treatment or other drugs in the treatment of narcolepsy.
MATERIAL/METHODS: The following electronic databases were searched throughout January 2009: MEDLINE, EMBASE and The Cochrane Library. Additional references were obtained from reviewed articles. Only randomized controlled trials were included.
We included 9 trials involving 1,054 patients in the study. Modafinil in comparison with placebo brings significant benefit in terms of elimination of excessive daytime sleepiness assessed by: ESS scale--weighted mean difference (WMD) -2.73 points (95%CI -3.39, -2.08), MSLT test--WMD 1.11 minutes (95%CI 0.55, 1.66) and MWT test--WMD 2.82 minutes (95%CI 2.40, 3.24), as well as the number and duration of somnolence, sleep attacks and naps per day, but was not different from placebo in the number of attacks of cataplexy per day. Modafinil in comparison with placebo improved quality of life of narcoleptic patients according to SF-36 questionnaire, but was associated with more common nausea. It had similar effect on excessive daytime sleepiness as sodium oxybate and was associated with less common nausea.
In narcoleptic patients, modafinil in comparison with placebo is effective in the treatment of excessive daytime sleepiness, but not cataplexy.
评估莫达非尼与无活性治疗或其他药物治疗发作性睡病的疗效和安全性。
材料/方法：检索了 2009 年 1 月的以下电子数据库：MEDLINE、EMBASE 和 Cochrane 图书馆。从综述文章中获得了其他参考文献。仅纳入随机对照试验。
我们纳入了 9 项涉及 1054 例患者的研究。与安慰剂相比，莫达非尼在消除日间过度嗜睡方面有显著益处，评估方法如下：ESS 量表——加权均数差（WMD）-2.73 分（95%CI-3.39，-2.08）、MSLT 测试——WMD 1.11 分钟（95%CI 0.55，1.66）和 MWT 测试——WMD 2.82 分钟（95%CI 2.40，3.24），以及白天嗜睡、睡眠发作和白天小睡的次数和持续时间，但在每日发作性猝倒的次数方面与安慰剂无差异。与安慰剂相比，莫达非尼改善了发作性睡病患者的生活质量，根据 SF-36 问卷，但与更常见的恶心有关。它在治疗日间过度嗜睡方面与羟丁酸钠有相似的效果，且恶心的发生频率较低。
在发作性睡病患者中，与安慰剂相比，莫达非尼治疗日间过度嗜睡有效，但对猝倒无效。
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