Modafinil for daytime somnolence in Parkinson's disease: double blind, placebo controlled parallel trial
Modafinil for daytime somnolence in Parkinson's disease: double blind, placebo controlled parallel trial
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DOI：
10.1136/jnnp.2005.065870
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发表时间：
2005-12-01
影响因子：
11
通讯作者：
Jankovic, J
中科院分区：
文献类型：
--
作者：
Ondo, WG;Fayle, R;Jankovic, J
背景：白天过度嗜睡 (EDS) 通常会使帕金森病 (PD) 复杂化。 EDS 的病因可能是多因素的，但多巴胺能药物可能会加剧这种情况。莫达非尼是一种被批准用于治疗发作性睡病的促醒剂，但它经常用于治疗各种嗜睡病症。 方法：进行了一项双盲、安慰剂对照平行设计试验，以评估莫达非尼（200 - 400 mg/天）治疗 PD 中 EDS 的疗效。主要疗效指标是 Epworth 嗜睡 (ES) 量表评分。次要疗效点包括统一帕金森病评定量表 (UPDRS)、疲劳严重程度量表、汉密尔顿抑郁量表和多次睡眠潜伏期测试 (MSLT)。 结果：在总共 40 名受试者（29 名男性，平均 (SD) 年龄 64.8 (11.3) 岁）中，随机接受莫达非尼或安慰剂组，其中 37 人完成了研究。与安慰剂相比，莫达非尼未能显着改善 ES 评分（分别提高 2.7 分和 1.5 分，p = 0.28）。与安慰剂相比，莫达非尼组的 MSLT 未能改善（分别为 -0.16 和 -0.70，p = 0.14）。 UPDRS、总体印象、疲劳严重程度量表和汉密尔顿抑郁量表评分未发生变化。不良事件很少。结论：与安慰剂相比，莫达非尼未能显着改善 PD 的 EDS。该药物不会改变帕金森病的运动症状，并且耐受性良好。
Background: Excessive daytime somnolence (EDS) commonly complicates Parkinson's disease (PD). The aetiology of EDS is probably multifactorial but is probably exacerbated by dopaminergic medications. Modafinil is a wake-promoting agent approved for use in narcolepsy, but it is often used to treat a variety of somnolent conditions.Method: A double blind, placebo controlled parallel design trial was conducted to assess the efficacy of modafinil ( 200 - 400 mg/day) for the treatment of EDS in PD. The primary efficacy measure was the Epworth Sleepiness (ES) scale score. Secondary efficacy points included the Unified Parkinson's Disease Rating Scale (UPDRS), the Fatigue Severity Scale, the Hamilton Depression Scale, and the multiple sleep latency test (MSLT).Results: Of a total of 40 subjects ( 29 men, mean (SD) age 64.8 (11.3) years), randomised to modafinil or placebo, 37 completed the study. Modafinil failed to significantly improve ES scores compared with placebo (2.7 v 1.5 points improvement, respectively, p = 0.28). MSLT failed to improve with modafinil relative to placebo (-0.16 v -0.70, respectively, p = 0.14). UPDRS, global impressions, Fatigue Severity Scale, and Hamilton Depression Scale scores were unchanged. Adverse events were minimal.Conclusion: Modafinil failed to significantly improve EDS in PD compared with placebo. The drug did not alter motor symptoms in PD and was well tolerated.