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随机对照试验:变压与定压持续气道正压通气(CPAP)治疗阻塞性睡眠呼吸暂停低通气综合征(OSAHS)患者的疗效比较。

Randomized controlled trial of variable-pressure versus fixed-pressure continuous positive airway pressure (CPAP) treatment for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS).

机构信息

Department of Sleep Medicine, Royal Infirmary of Edinburgh, Edinburgh, UK.

出版信息

Sleep. 2010 Feb;33(2):267-71. doi: 10.1093/sleep/33.2.267.

DOI:10.1093/sleep/33.2.267
PMID:20175411
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2817914/
Abstract

STUDY OBJECTIVE

To determine whether fixed-pressure or variable-pressure CPAP was preferred by patients and gave better outcomes in patients with the obstructive sleep apnea/hypopnea syndrome (OSAHS).

DESIGN

Randomized blinded cross-over trial with 6 weeks of fixed and 6 weeks of variable-pressure CPAP.

SETTING

Sleep center.

PATIENTS

200 consecutive consenting CPAP naïve patients with daytime sleepiness and > 15 apneas + hypopneas/h after an attended auto-CPAP titration night.

INTERVENTIONS

CPAP therapy using the same device (Autoset Spirit) set for 6 weeks in fixed pressure mode and for 6 weeks in variable pressure mode, the order of therapies being randomized.

MEASUREMENTS AND RESULTS

All measurements were recorded at the end of each limb by a researcher blind to treatment. These included symptoms, Epworth Score, CPAP usage, objective sleepiness by modified Osler test, vigilance and health related quality of life. A total of 181 of 200 patients completed the study. At the end of the study, patients expressed no significant difference in the primary outcome, patient preference, 72 patients preferring fixed and 69 preferring variable-pressure CPAP. Epworth score was lower on variable (9.5, SEM 0.4) than fixed-pressure CPAP (10.0, SEM 0.3; P = 0.031). Mean CPAP use was higher on variable (4.2, SEM 0.2 h/night) than fixed-pressure CPAP (4.0, SEM 0.2 h/night; P = 0.047). There were no other significant differences between treatments. CONCLUSIONS This study shows no difference in patient preference and only a marginal benefit of variable over fixed-pressure CPAP in OSAHS in terms of subjective sleepiness and CPAP use. The clinical value of this difference remains to be determined.

CLINICAL TRIAL INFORMATION

Variable-pressure versus fixed-pressure continuous positive airway pressure (CPAP) treatment for patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS); Registration # ISRCTN43085025.http://www.controlled-trials.com//SRCTN43085025.

摘要

研究目的

确定固定压力或可变压力 CPAP 模式更受患者偏好,并为阻塞性睡眠呼吸暂停低通气综合征(OSAHS)患者带来更好的结局。

设计

随机、双盲交叉试验,分别给予患者 6 周固定压力 CPAP 和 6 周可变压力 CPAP 治疗。

设置

睡眠中心。

患者

200 例连续同意的 CPAP 初治患者,白天嗜睡,经 attended auto-CPAP 滴定夜后,每小时呼吸暂停+低通气次数>15 次。

干预措施

使用同一设备(Autoset Spirit)进行 CPAP 治疗,固定压力模式治疗 6 周,可变压力模式治疗 6 周,治疗顺序随机。

测量和结果

每项测量均在每一肢治疗结束时由一名对治疗方案不知情的研究者记录。这些测量包括症状、Epworth 评分、CPAP 使用情况、改良 Osler 试验评估的客观嗜睡程度、警觉性和健康相关生活质量。共有 200 例患者中的 181 例完成了研究。研究结束时,患者在主要结局、患者偏好方面均无显著差异,72 例患者更喜欢固定压力 CPAP,69 例患者更喜欢可变压力 CPAP。可变压力 CPAP 组的 Epworth 评分(9.5,SEM 0.4)低于固定压力 CPAP 组(10.0,SEM 0.3;P=0.031)。可变压力 CPAP 组的平均 CPAP 使用时间(4.2,SEM 0.2 小时/夜)高于固定压力 CPAP 组(4.0,SEM 0.2 小时/夜;P=0.047)。两种治疗方案之间无其他显著差异。

结论

本研究表明,在 OSAHS 患者中,与固定压力 CPAP 相比,可变压力 CPAP 在患者偏好方面无差异,仅在主观嗜睡和 CPAP 使用方面有轻微获益。这种差异的临床价值仍有待确定。

临床试验信息

可变压力与固定压力持续气道正压通气(CPAP)治疗阻塞性睡眠呼吸暂停低通气综合征(OSAHS)患者;注册号 ISRCTN43085025.http://www.controlled-trials.com//SRCTN43085025。

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