INSERM 1042, HP2 Laboratory, Université Joseph Fourier, Faculté de Médecine, Grenoble.
INSERM 1042, HP2 Laboratory, Université Joseph Fourier, Faculté de Médecine, Grenoble; Pôle Rééducation et Physiologie, CHU, Hôpital A. Michallon, Grenoble.
Chest. 2012 Mar;141(3):692-702. doi: 10.1378/chest.10-2531. Epub 2011 Sep 1.
Open studies suggest that treatment of obesity hypoventilation syndrome (OHS) by noninvasive ventilation (NIV) restores sleep quality and daytime vigilance and reduces cardiovascular morbidity. However, to our knowledge no randomized controlled trial (RCT) comparing NIV to conservative measures is available in the field. The goal of this study was to assess in patients with OHS, during an RCT, effects of 1-month NIV compared with lifestyle counseling on blood gas measurements, sleep quality, vigilance, and cardiovascular, metabolic, and inflammatory parameters.
Thirty-five patients in whom OHS was newly diagnosed were randomized either to the NIV group or the control group represented by lifestyle counseling. Assessments included blood gas levels, subjective daytime sleepiness, metabolic parameters, inflammatory (hsCRP, leptin, regulated upon activation normal T-cell express and secreted [RANTES], monocyte chemoattractant protein-1, IL-6, IL-8, tumor necrosis factor-α, resistin) and antiinflammatory (adiponectin, IL-1-RA) cytokines, sleep studies, endothelial function (reactive hyperemia measured by peripheral arterial tonometry [RH-PAT]), and arterial stiffness.
Despite randomization, NIV group patients (n = 18) were older (58 ± 11 years vs 54 ± 6 years) with a higher baseline Paco(2) (47.9 ± 4.2 mm Hg vs 45.2 ± 3 mm Hg). In intention-to-treat analysis, compared with control group, NIV treatment significantly reduced daytime Paco(2) (difference between treatments: -3.5 mm Hg; 95% CI, -6.2 to -0.8) and apnea-hypopnea index (-40.3/h; 95% CI, -62.4 to -18.2). Sleep architecture was restored, although nonrespiratory microarousals increased (+9.4/h of sleep; 95% CI, 1.9-16.9), and daytime sleepiness was not completely normalized. Despite a dramatic improvement in sleep hypoxemia, glucidic and lipidic metabolism parameters as well as cytokine profiles did not vary significantly. Accordingly, neither RH-PAT (+0.02; 95% CI, -0.24 to 0.29) nor arterial stiffness (+0.22 m/s; 95% CI, -1.47 to 1.92) improved.
One month of NIV treatment, although improving sleep and blood gas measurements dramatically, did not change inflammatory, metabolic, and cardiovascular markers.
ClinicalTrials.gov; No.: NCT00603096; URL: www.clinicaltrials.gov.
开放性研究表明，通过无创通气（NIV）治疗肥胖低通气综合征（OHS）可恢复睡眠质量和日间警觉性，并降低心血管发病率。然而，据我们所知，在该领域尚无比较 NIV 与保守治疗的随机对照试验（RCT）。本研究的目的是在 RCT 中评估新诊断为 OHS 的患者接受 1 个月的 NIV 治疗与生活方式咨询相比，对血气测量、睡眠质量、警觉性以及心血管、代谢和炎症参数的影响。
35 例新诊断为 OHS 的患者被随机分为 NIV 组或生活方式咨询对照组。评估包括血气水平、日间嗜睡主观评估、代谢参数、炎症（hsCRP、瘦素、调节激活正常 T 细胞表达和分泌[RANTES]、单核细胞趋化蛋白-1、IL-6、IL-8、肿瘤坏死因子-α、抵抗素）和抗炎（脂联素、IL-1-RA）细胞因子、睡眠研究、内皮功能（通过外周动脉张力测量的反应性充血[RH-PAT]）和动脉僵硬度。
尽管进行了随机分组，NIV 组患者（n=18）年龄更大（58±11 岁 vs. 54±6 岁），基线 Paco2 更高（47.9±4.2mmHg vs. 45.2±3mmHg）。在意向治疗分析中，与对照组相比，NIV 治疗显著降低了日间 Paco2（治疗差异：-3.5mmHg；95%CI，-6.2 至-0.8）和呼吸暂停-低通气指数（-40.3/h；95%CI，-62.4 至-18.2）。尽管恢复了睡眠结构，但非呼吸性微觉醒增加（+9.4/h 睡眠；95%CI，1.9-16.9），日间嗜睡并未完全正常化。尽管睡眠低氧血症显著改善，但糖脂代谢参数和细胞因子谱并未显著变化。因此，RH-PAT（+0.02；95%CI，-0.24 至 0.29）和动脉僵硬度（+0.22m/s；95%CI，-1.47 至 1.92）均未改善。
尽管 NIV 治疗 1 个月可显著改善睡眠和血气测量，但并未改变炎症、代谢和心血管标志物。
ClinicalTrials.gov；编号：NCT00603096；网址：www.clinicaltrials.gov。
