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羟丁酸钠、莫达非尼及联合治疗对伴或不伴猝倒发作的发作性睡病患者日间过度嗜睡的影响

Impact of sodium oxybate, modafinil, and combination treatment on excessive daytime sleepiness in patients who have narcolepsy with or without cataplexy.

作者信息

Black Jed, Swick Todd, Bogan Richard, Lai Chinglin, Carter Lawrence P

机构信息

Jazz Pharmaceuticals, Palo Alto, CA, USA; Stanford Sleep Medicine Center, Redwood City, CA, USA.

Neurology and Sleep Medicine Consultants of Houston, Houston, TX, USA.

出版信息

Sleep Med. 2016 Aug;24:57-62. doi: 10.1016/j.sleep.2016.07.010. Epub 2016 Aug 22.

Abstract

BACKGROUND

Effects of sodium oxybate (SXB) on patients with narcolepsy with cataplexy (NC) or without cataplexy (NWOC) have not been separately evaluated in clinical trials.

METHODS

Retrospective analysis evaluated data from a phase 3, randomized, placebo-controlled trial of SXB, modafinil, and SXB + modafinil versus placebo in adult NC patients (n = 95) or NWOC patients (n = 127). NC patients were identified based on medical history, concomitant medications, and sleep-onset REM periods on nocturnal polysomnography. The studied outcomes were changes from baseline at eight weeks on the Epworth Sleepiness Scale (ESS), the Maintenance of Wakefulness Test (MWT), and the Clinical Global Impression of Change (CGI-C).

RESULTS

Among NC and NWOC patients, ESS improvement was significantly greater with SXB and SXB + modafinil versus placebo. In NC patients, mean MWT sleep latency was significantly increased with SXB + modafinil versus placebo. In NWOC patients, mean MWT sleep latency significantly increased in all groups versus placebo. Higher percentages of patients in the SXB and SXB + modafinil groups were "very much improved" or "much improved" on the CGI-C versus placebo in both NC and NWOC populations, although the difference did not reach statistical significance in the NWOC populations. Adverse events were consistent with previously-reported profiles for modafinil and SXB. Nausea was more common in the SXB and SXB + modafinil groups. Dizziness and tremor were more common in the SXB + modafinil group only.

CONCLUSIONS

SXB alone and in combination with modafinil improved subjective ratings of excessive sleepiness and an objective measure of the ability to stay awake to similar extents in NC patients and NWOC patients.

摘要

背景

在临床试验中,尚未分别评估羟丁酸钠(SXB)对发作性睡病伴猝倒(NC)或不伴猝倒(NWOC)患者的影响。

方法

回顾性分析评估了一项3期随机安慰剂对照试验的数据,该试验比较了SXB、莫达非尼、SXB + 莫达非尼与安慰剂在成年NC患者(n = 95)或NWOC患者(n = 127)中的疗效。根据病史、伴随用药以及夜间多导睡眠图上的睡眠起始快速眼动期来确定NC患者。研究的结局指标为治疗8周时,爱泼华嗜睡量表(ESS)、清醒维持试验(MWT)以及临床总体印象变化量表(CGI-C)较基线的变化。

结果

在NC和NWOC患者中,SXB和SXB + 莫达非尼组的ESS改善程度显著高于安慰剂组。在NC患者中,SXB + 莫达非尼组的平均MWT睡眠潜伏期较安慰剂组显著延长。在NWOC患者中,所有治疗组的平均MWT睡眠潜伏期较安慰剂组均显著延长。在NC和NWOC人群中,SXB和SXB + 莫达非尼组“改善非常明显”或“改善明显”的患者比例高于安慰剂组,尽管在NWOC人群中差异未达到统计学意义。不良事件与先前报道的莫达非尼和SXB的情况一致。恶心在SXB和SXB + 莫达非尼组中更为常见。头晕和震颤仅在SXB + 莫达非尼组中更为常见。

结论

单独使用SXB以及SXB与莫达非尼联合使用,在NC患者和NWOC患者中,对过度嗜睡的主观评分以及保持清醒能力的客观指标的改善程度相似。

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