莫达非尼治疗阻塞性睡眠呼吸暂停低通气综合征导致白天过度嗜睡的双盲、随机对照、多中心临床试验

Modafinil in treatment of excessive daytime sleepiness induced by obstructive sleep apnea hypopnea syndrome: a double-blind, randomized controlled and multicenter clinical trial

目的评价莫达非尼治疗阻塞性睡眠呼吸暂停低通气综合征(OSAHS)导致白天过度嗜睡的有效性和安全性。方法共209例OSAHS导致白天过度嗜睡患者被随机分入试验组(106例)和对照组(103例),分别每日1次口服莫达非尼200 mg或安慰剂,疗程为4周。记录白天过度嗜睡次数、嗜睡时间,评定症状体征总积分和Epworth睡眠量表(ESS)评分,比较2组治疗总有效率及安全性。结果试验组和对照组的治疗总有效率分别为77.1%和43.7%,痊愈率分别为14.3%和2.9%,试验组明显优于对照组(P <0.01)。试验组的症状体征总积分、 ESS评分、嗜睡次数、嗜睡时间在治疗4周后与对照组比较均有显著差异(P <0.05)。试验组和对照组不良事件的发生率分别为15.2%和6.8%,组间无显著差异(P>0.05),均未出现严重不良事件。结论莫达非尼治疗OSAHS导致的白天过度嗜睡安全、有效。

AIM To evaluate the efficacy and safety of modafinil in the treatment of excessive daytime sleepiness(EDS) caused by obstructive sleep apnea hypopnea syndrome(OSAHS). METHODS A total of 209 patients with EDS caused by OSAHS were randomly divided into trial group(n = 106) and control group(n =103), with modafinil 200 mg or placebo orally administered once a day for 4 weeks respectively. The number and time of EDS were recorded, the total score of symptoms and signs and the Epworth sleepiness scale(ESS)were evaluated, and the total effective rate and safety of the two groups were compared. RESULTS The total effective rate of the trial group and the control group were 77.1% and 43.7%, and the recovery rate was 14.3%and 2.9%, respectively. The trial group was significantly better than the control group(P < 0.01). The total score of symptoms and signs, ESS score, number of sleepiness and time of sleepiness in the trial group were significantly different from those in the control group after 4 weeks of treatment( P < 0.05). The incidence of adverse events in the trial group and the control group were 15.2% and 6.8%, respectively, with no significant difference between the two groups( P > 0.05). There were no serious adverse events reported in both groups.CONCLUSION Modafinil is safe and effective in the treatment of EDS caused by OSAHS.