1 San Pedro de Alcantara Hospital, Caceres, Spain.
2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.
Am J Respir Crit Care Med. 2015 Jul 1;192(1):86-95. doi: 10.1164/rccm.201410-1900OC.
The incidence of obesity hypoventilation syndrome (OHS) may be increasing in parallel with the present obesity epidemic. Despite extensive noninvasive ventilation (NIV) and continuous positive airway pressure (CPAP) use in patients with OHS, information regarding efficacy is limited.
We performed a large, multicenter randomized controlled study to determine the comparative efficacy of NIV, CPAP, and lifestyle modification (control group) using daytime PaCO2 as the main outcome measure.
Sequentially screened patients with OHS with severe sleep apnea were randomized into the above-mentioned groups for a 2-month follow up. Arterial blood gas parameters, clinical symptoms, health-related quality-of-life assessments, polysomnography, spirometry, 6-minute-walk distance, dropouts, compliance, and side effects were evaluated. Statistical analysis was performed using intention-to-treat analysis, although adjustments for CPAP and NIV compliance were also analyzed.
In total, 351 patients were selected, and 221 were randomized. NIV yielded the greatest improvement in PaCO2 and bicarbonate, with significant differences relative to the control group but not relative to the CPAP group. In the CPAP group, PaCO2 improvement was significantly different than in the control group only after CPAP compliance adjustment. Additionally, clinical symptoms and polysomnographic parameters improved similarly with NIV and CPAP relative to the control. However, some health-related quality-of-life assessments, the spirometry, and 6-minute-walk distance results improved more with NIV than with CPAP. Dropouts were similar between groups, and compliance and secondary effects were similar between NIV and CPAP.
NIV and CPAP were more effective than lifestyle modification in improving clinical symptoms and polysomnographic parameters, although NIV yielded better respiratory functional improvements than did CPAP. Long-term studies must demonstrate whether this functional improvement has relevant implications. Clinical trial registered with www.clinicaltrials.gov (NCT01405976).
肥胖低通气综合征（OHS）的发病率可能与当前肥胖流行呈平行上升趋势。尽管 OHS 患者广泛使用无创通气（NIV）和持续气道正压通气（CPAP），但其疗效信息有限。
我们进行了一项大型、多中心随机对照研究，以确定 NIV、CPAP 和生活方式改变（对照组）的疗效比较，主要观察指标为日间 PaCO2。
对患有严重睡眠呼吸暂停的 OHS 患者进行连续筛查，然后将其随机分为上述各组进行为期 2 个月的随访。评估动脉血气参数、临床症状、健康相关生活质量评估、多导睡眠图、肺功能、6 分钟步行距离、脱落、依从性和副作用。尽管对 CPAP 和 NIV 依从性进行了调整，但仍使用意向治疗分析进行了统计分析。
共选择了 351 例患者，其中 221 例被随机分组。与对照组相比，NIV 使 PaCO2 和碳酸氢盐的改善最大，但与 CPAP 组相比无显著差异。仅在调整 CPAP 依从性后，CPAP 组 PaCO2 的改善才与对照组有显著差异。此外，与对照组相比，NIV 和 CPAP 均可显著改善临床症状和多导睡眠图参数。然而，一些健康相关生活质量评估、肺功能和 6 分钟步行距离结果的改善，NIV 比 CPAP 更为显著。各组之间的脱落率相似，NIV 和 CPAP 的依从性和次要影响也相似。
NIV 和 CPAP 比生活方式改变更能改善临床症状和多导睡眠图参数，但 NIV 对呼吸功能的改善优于 CPAP。必须进行长期研究，以确定这种功能改善是否具有重要意义。该临床试验已在 www.clinicaltrials.gov（NCT01405976）注册。
