Montserrat J M, Ferrer M, Hernandez L, Farré R, Vilagut G, Navajas D, Badia J R, Carrasco E, De Pablo J, Ballester E
Institut Clínic de Pneumologia i Cirurgia Toràcica and Servei de Psiquiatria, Hospital Clínic, Barcelona, Spain.
Am J Respir Crit Care Med. 2001 Aug 15;164(4):608-13. doi: 10.1164/ajrccm.164.4.2006034.
Application of continuous positive airway pressure (CPAP) as the standard treatment for sleep apnea/hypopnea syndrome (SAHS) is a moot point. Studies on the effectiveness of this treatment have been challenged because of the lack of a suitable placebo. The recent description of a true placebo (sham CPAP) prompted us to conduct a randomized trial of CPAP or placebo to assess the effectiveness of CPAP in improving SAHS-related symptoms and daytime function in patients with moderate to severe SAHS. Forty-eight patients, stratified in four groups according to severity, were randomly allocated into two treatment groups (optimal and sham CPAP) for a 6-wk period. Of these, 45 completed follow-up (91% males; age: 54 +/- 10 yr; body mass index [BMI]: 32 +/- 6 kg/m(2); apnea-hypopnea index [AHI]: 54 +/- 19 events/h; and Epworth Sleepiness Scale [ESS]: 16 +/- 5). The ESS, a questionnaire on SAHS-related symptoms, Functional Outcomes Sleep Questionnaire (FOSQ), and the Short Form Health Survey (SF-36) were completed at inclusion and after treatment. After 10 d of washout, the placebo group was treated with optimal CPAP and reassessed before and after optimal CPAP. The group receiving optimal CPAP when compared with the group with sham CPAP showed considerably greater improvement in the relief of sleepiness (-9.5 versus -2.3, p < 0.001), other SAHS-related symptoms (-18.5 versus -4.5, p < 0.001), vigilance (+8.5 versus +3.4, p = 0.009), and general productivity (+4.0 versus +0.5, p = 0.04) FOSQ scales. Both groups used a similar number of hours for the optimal and the sham CPAP (4.3 versus 4.5, (p = NS). The patients initially treated with placebo CPAP improved significantly more when optimal CPAP was applied for ESS (-2.3 versus -6.7, p < 0.001) and other sleep apnea syndrome (SAS)-related symptoms (-4.5 versus -11.2, p = 0.02). Our study provides strong evidence of the effectiveness of CPAP treatment in improving symptoms and perceived health status in moderate to severe SAHS.
持续气道正压通气（CPAP）作为睡眠呼吸暂停/低通气综合征（SAHS）的标准治疗方法，其应用存在争议。由于缺乏合适的安慰剂，关于这种治疗有效性的研究受到了挑战。最近对一种真正安慰剂（假CPAP）的描述促使我们进行一项CPAP或安慰剂的随机试验，以评估CPAP对改善中重度SAHS患者SAHS相关症状和日间功能的有效性。48名患者根据严重程度分为四组，随机分配到两个治疗组（最佳CPAP组和假CPAP组），为期6周。其中，45名患者完成了随访（91%为男性；年龄：54±10岁；体重指数[BMI]：32±6kg/m²；呼吸暂停低通气指数[AHI]：54±19次/小时；爱泼沃斯思睡量表[ESS]：16±5）。在纳入研究时和治疗后，完成了关于SAHS相关症状的问卷ESS、功能性睡眠结果问卷（FOSQ）和简短健康调查（SF - 36）。在洗脱10天后，安慰剂组接受最佳CPAP治疗，并在最佳CPAP治疗前后重新评估。与假CPAP组相比，接受最佳CPAP治疗的组在缓解嗜睡方面有显著更大的改善（-9.5对-2.3，p<0.001），在其他SAHS相关症状方面（-18.5对-4.5，p<0.001），在警觉性方面（+8.5对+3.4，p = 0.009），以及在总体生产力方面（+4.0对+0.5，p = 0.04）的FOSQ量表得分更高。两组使用最佳CPAP和假CPAP的小时数相似（4.3对4.5，（p = 无显著差异）。最初接受安慰剂CPAP治疗的患者在应用最佳CPAP时，在ESS（-2.3对-6.7，p<0.001）和其他睡眠呼吸暂停综合征（SAS）相关症状（-4.5对-11.2，p = 0.02）方面改善更为显著。我们的研究提供了有力证据，证明CPAP治疗在改善中重度SAHS患者的症状和感知健康状况方面是有效的。
