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莫达非尼对急性持续气道正压通气撤机过程中的影响:一项随机交叉双盲安慰剂对照试验。

Modafinil effects during acute continuous positive airway pressure withdrawal: a randomized crossover double-blind placebo-controlled trial.

机构信息

Sleep and Circadian Research Group/NHMRC Centre for Sleep Medicine, Woolcock Institute, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia.

出版信息

Am J Respir Crit Care Med. 2010 Apr 15;181(8):825-31. doi: 10.1164/rccm.200908-1307OC. Epub 2010 Jan 7.

DOI:10.1164/rccm.200908-1307OC
PMID:20056901
Abstract

RATIONALE

Continuous positive airway pressure (CPAP) use is associated with reduced motor vehicle accidents in patients with obstructive sleep apnea (OSA). However, interruption of CPAP therapy is common and is associated with a decline in daytime function.

OBJECTIVES

We hypothesized that the wakefulness promoter, modafinil, would ameliorate this decline.

METHODS

Patients were admitted to the laboratory for three consecutive nights. CPAP was used for the first night, followed by a baseline day, and was then withdrawn for the two subsequent nights (nasal airflow monitored). On each of the mornings after the two CPAP withdrawal nights, patients received 200 mg modafinil or placebo (n = 21) in a randomized, double-blind, crossover design. Treatment periods were separated by a 5-week washout. Driving simulator performance, neurocognitive performance, and subjective alertness were measured by the AusEd driving simulator, psychomotor vigilance task, and Karolinska Sleepiness Scale, respectively.

MEASUREMENTS AND MAIN RESULTS

During CPAP withdrawal, severe sleep-disordered breathing was evident and administration of modafinil improved simulated driving performance (steering variability, P < 0.0001; mean reaction time, P <or= 0.0002; lapses, P <or= 0.01 on a concurrent task), psychomotor vigilance task (mean 1/reaction time and lapses, both P <or= 0.0002), and subjective sleepiness (P <or= 0.01).

CONCLUSIONS

Modafinil prevented the decline in simulated driving performance, neurocognitive performance, and subjective sleepiness in patients with OSA with acutely interrupted CPAP therapy. Clinical trial registered with the Australian New Zealand Clinical Trials Registry at www.anzctr.org.au (ACTRN12606000027516).

摘要

原理

持续气道正压通气(CPAP)的使用与阻塞性睡眠呼吸暂停(OSA)患者的机动车事故减少有关。然而,CPAP 治疗的中断很常见,并且与白天功能下降有关。

目的

我们假设觉醒促进剂莫达非尼可以改善这种下降。

方法

患者连续三晚入住实验室。第一晚使用 CPAP,然后进行基线日,随后在接下来的两个晚上(监测鼻气流)停用 CPAP。在两个 CPAP 停用晚上后的每个早晨,患者以随机、双盲、交叉设计的方式接受 200mg 莫达非尼或安慰剂(n=21)。治疗期之间有 5 周的洗脱期。驾驶模拟器性能、神经认知性能和主观警觉性分别通过 AusEd 驾驶模拟器、精神运动警觉任务和 Karolinska 嗜睡量表进行测量。

测量和主要结果

在 CPAP 停药期间,明显存在严重的睡眠呼吸障碍紊乱,而给予莫达非尼可改善模拟驾驶性能(转向变异性,P<0.0001;平均反应时间,P<0.0002;在并行任务中出现失误,P<0.01)、精神运动警觉任务(平均 1/反应时间和失误,两者均 P<0.0002)和主观嗜睡(P<0.01)。

结论

莫达非尼可预防急性中断 CPAP 治疗的 OSA 患者模拟驾驶性能、神经认知性能和主观嗜睡下降。该临床试验在澳大利亚新西兰临床试验注册处(www.anzctr.org.au)进行,注册号为 ACTRN12606000027516。

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