在持续气道正压通气治疗效果欠佳的中重度阻塞性睡眠呼吸暂停且伴有日间过度嗜睡的患者中，阿莫达非尼的疗效：一项前瞻性研究。
Efficacy of armodafinil in moderate to severe obstructive sleep apnea patients with excessive daytime sleepiness after suboptimal usage of continuous positive airway pressure treatment: a prospective study.
作者信息
Ngeyvijit Jinjuta, Desudchit Tayard, Dadphan Nattapot, Aswanetmanee Pantaree, Muntham Dittapol, Chirakalwasan Naricha
机构信息
Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, 1873 Rama IV Road, Pathum Wan, Bangkok, 10330, Thailand.
Division of Pediatric Neurology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.
出版信息
Sleep Breath. 2025 Sep 4;29(5):280. doi: 10.1007/s11325-025-03448-3.
PURPOSE
Armodafinil has been approved for treating excessive daytime sleepiness (EDS) in OSA patients who still experience EDS after adequately treated with CPAP. However, the effectiveness of armodafinil administration in OSA patients with suboptimal CPAP usage and persistent EDS remains unexplored.
METHOD
A 12-week prospective cohort study enrolled 33 moderate to severe OSA patients with suboptimal CPAP usage (2- < 4 h/night) who experienced EDS and were naïve to armodafinil. Patients received daily 150 mg of armodafinil and continued using CPAP. Efficacy and adverse events were evaluated.
RESULTS
A total of 30 patients with mean age of 45.10 ± 10.74 years and Epworth sleepiness scale (ESS) of 13.93 ± 3.16 completed the study; however, one participant completed only the 8-week follow-up. After 12 weeks, ESS was significantly decreased by 5.03 ± 4.22 (p < 0.001). Clinical global impression (CGI) rated by investigators and by participants was significantly decreased by 1.79 ± 0.72 (p < 0.001) and 1.93 ± 0.75 (p < 0.001); respectively. Pittsburgh sleep quality index (PSQI) was significantly decreased by 5.27 ± 2.93 (p < 0.001). The OSLER error index did not significantly improved (p = 0.61); however, a trend toward improvement was observed in patients with baseline psychomotor vigilance impairment (p = 0.17). While CPAP adherence showed no statistically significant change, there was a trend toward improvement from 2.99 ± 0.63 h/night at baseline to 3.47 ± 1.38 h/night (p = 0.09). No serious side effects were observed.
CONCLUSION
In moderate to severe OSA patients with suboptimal CPAP usage who still experience EDS, administering armodafinil over 12 weeks period significantly improved EDS and sleep quality subjectively without compromising CPAP adherence. Armodafinil demonstrated excellent tolerability with self-limiting side effects.
目的
阿莫达非尼已被批准用于治疗阻塞性睡眠呼吸暂停（OSA）患者在接受持续气道正压通气（CPAP）充分治疗后仍存在的日间过度嗜睡（EDS）。然而，在CPAP使用不理想且持续存在EDS的OSA患者中，服用阿莫达非尼的有效性仍未得到探索。
方法
一项为期12周的前瞻性队列研究纳入了33例CPAP使用不理想（每晚2 - ＜4小时）且有EDS症状且未使用过阿莫达非尼的中重度OSA患者。患者每日服用150毫克阿莫达非尼，并继续使用CPAP。评估疗效和不良事件。
结果
共有30例平均年龄为45.10±10.74岁、爱泼沃斯嗜睡量表（ESS）评分为13.93±3.16的患者完成了研究；然而，有1名参与者仅完成了8周的随访。12周后，ESS显著降低了5.03±4.22（p＜0.001）。研究者和参与者评定的临床总体印象（CGI）分别显著降低了1.79±0.72（p＜0.001）和1.93±0.75（p＜0.001）。匹兹堡睡眠质量指数（PSQI）显著降低了5.27±2.93（p＜0.001）。OSLER错误指数没有显著改善（p = 0.61）；然而，在基线时有精神运动警觉性损害的患者中观察到有改善趋势（p = 0.17）。虽然CPAP依从性没有统计学上的显著变化，但有从基线时每晚2.99±0.63小时改善到3.47±1.38小时的趋势（p = 0.09）。未观察到严重副作用。
结论
在CPAP使用不理想且仍有EDS症状的中重度OSA患者中，服用阿莫达非尼12周可显著改善主观上的EDS和睡眠质量，且不影响CPAP依从性。阿莫达非尼表现出良好的耐受性，副作用具有自限性。
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