气道正压通气起始：一项随机对照试验，旨在评估治疗模式和滴定过程对疗效、依从性和结局的影响。
Positive airway pressure initiation: a randomized controlled trial to assess the impact of therapy mode and titration process on efficacy, adherence, and outcomes.
机构信息
Stanford University, Stanford, CA, USA.
出版信息
Sleep. 2011 Aug 1;34(8):1083-92. doi: 10.5665/SLEEP.1166.
STUDY OBJECTIVES
(1) To determine the efficacy of automatically adjusted positive airway pressure (APAP) with a comfort feature (A-Flex) at reducing apneas and hypopneas in participants with moderate to severe OSA. (2) To determine the relative difference between A-Flex, continuous positive airway pressure (CPAP), and APAP-derived optimal pressure for CPAP (CPAP(APAP)) on adherence to treatment. (3) To determine the relative difference between APAP with A-Flex, CPAP, and CPAP(APAP) on long-term change in functional outcomes.
DESIGN
Randomized, double-blinded, 3-arm, multicenter trial.
SETTING
University and Veterans Affairs medical centers.
PATIENTS OR PARTICIPANTS
168 participants were randomized, and 140 completed the 180-day study.
INTERVENTIONS
(1) A-Flex; (2) CPAP; (3) APAP for 14 days and then switched to CPAP at a fixed pressure.
MEASUREMENTS AND RESULTS
Apnea-hypopnea indices, average and minimum oxygen saturation, time spent < 90% were significantly poorer for A-Flex vs. CPAP at the initiation of study treatment; with the exception of minimum oxygen saturation, these differences were absent at 180 days. A-Flex had lower average leak values at both 3 and 6 months. There were no significant differences between groups in major efficacy, adherence, and outcome (subjective sleepiness, objective vigilance, blood pressure, quality of life) measures. No differences between groups in attitudes toward use were observed at 3 or 6 months; participant ratings for CPAP were significantly higher than A-Flex on treatment satisfaction and benefit, but not different for sleep quality and mask comfort.
CONCLUSIONS
We found that A-Flex shows equivalency, but non-superiority (except for average leak values), in efficacy, adherence, and functional outcomes compared to CPAP after either 3 or 6 months.
CLINICAL TRIAL REGISTRY
Positive Pressure Treatment of Obstructive Sleep Apnea, http://www.clinicaltrials.gov, NCT00636181.
研究目的
（1）确定具有舒适功能（A-Flex）的自动调整正压通气（APAP）在减少中重度 OSA 患者呼吸暂停和低通气方面的疗效。（2）确定 A-Flex、持续气道正压通气（CPAP）和 APAP 衍生 CPAP 最佳压力（CPAP(APAP)）在治疗依从性方面的相对差异。（3）确定具有 A-Flex 的 APAP、CPAP 和 CPAP(APAP)在长期功能结局变化方面的相对差异。
设计
随机、双盲、三臂、多中心试验。
地点
大学和退伍军人事务医疗中心。
患者或参与者
168 名患者被随机分组，140 名患者完成了 180 天的研究。
干预措施
（1）A-Flex；（2）CPAP；（3）APAP 治疗 14 天，然后切换至固定压力 CPAP。
测量和结果
与 CPAP 相比，A-Flex 在研究治疗开始时呼吸暂停-低通气指数、平均和最低血氧饱和度、<90%时间明显更差；除最低血氧饱和度外，这些差异在 180 天时消失。A-Flex 在 3 个月和 6 个月时的平均漏气量值均较低。各组在主要疗效、依从性和结局（主观嗜睡、客观警觉、血压、生活质量）测量方面无显著差异。在 3 个月或 6 个月时，各组之间对使用的态度无差异；在治疗满意度和获益方面，患者对 CPAP 的评分明显高于 A-Flex，但在睡眠质量和面罩舒适度方面则无差异。
结论
我们发现，与 CPAP 相比，A-Flex 在 3 个月或 6 个月后在疗效、依从性和功能结局方面具有等效性（除平均漏气量值外），但不具有优越性。
临床试验注册
阻塞性睡眠呼吸暂停正压治疗，http://www.clinicaltrials.gov，NCT00636181。
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