稳定期高碳酸血症慢性阻塞性肺疾病患者夜间无创经鼻通气：一项随机对照试验。

Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial.

作者信息

McEvoy R D, Pierce R J, Hillman D, Esterman A, Ellis E E, Catcheside P G, O'Donoghue F J, Barnes D J, Grunstein R R

机构信息

Adelaide Institute for Sleep Health, Repatriation General Hospital and Flinders University, Australia.

出版信息

Thorax. 2009 Jul;64(7):561-6. doi: 10.1136/thx.2008.108274. Epub 2009 Feb 12.

DOI:10.1136/thx.2008.108274

PMID:19213769

Abstract

BACKGROUND

Sleep hypoventilation has been proposed as a cause of progressive hypercapnic respiratory failure and death in patients with severe chronic obstructive pulmonary disease (COPD). A study was undertaken to determine the effects of nocturnal non-invasive bi-level pressure support ventilation (NIV) on survival, lung function and quality of life in patients with severe hypercapnic COPD.

METHOD

A multicentre, open-label, randomised controlled trial of NIV plus long-term oxygen therapy (LTOT) versus LTOT alone was performed in four Australian University Hospital sleep/respiratory medicine departments in patients with severe stable smoking-related COPD (forced expiratory volume in 1 s (FEV1.0) <1.5 litres or <50% predicted and ratio of FEV1.0 to forced vital capacity (FVC) <60% with awake arterial carbon dioxide tension (PaCO2) >46 mm Hg and on LTOT for at least 3 months) and age <80 years. Patients with sleep apnoea (apnoea-hypopnoea index >20/h) or morbid obesity (body mass index >40) were excluded. Outcome measures were survival, spirometry, arterial blood gases, polysomnography, general and disease-specific quality of life and mood.

RESULTS

144 patients were randomised (72 to NIV + LTOT and 72 to LTOT alone). NIV improved sleep quality and sleep-related hypercapnia acutely, and patients complied well with therapy (mean (SD) nightly use 4.5 (3.2) h). Compared with LTOT alone, NIV (mean follow-up 2.21 years, range 0.01-5.59) showed an improvement in survival with the adjusted but not the unadjusted Cox model (adjusted hazard ratio (HR) 0.63, 95% CI 0.40 to 0.99, p = 0.045; unadjusted HR 0.82, 95% CI 0.53 to 1.25, p = NS). FEV1.0 and PaCO2 measured at 6 and 12 months were not different between groups. Patients assigned to NIV + LTOT had reduced general and mental health and vigour.

CONCLUSIONS

Nocturnal NIV in stable oxygen-dependent patients with hypercapnic COPD may improve survival, but this appears to be at the cost of worsening quality of life.

TRIAL REGISTRATION NUMBER

ACTRN12605000205639.

摘要

背景

睡眠低通气已被认为是导致重度慢性阻塞性肺疾病（COPD）患者进行性高碳酸血症呼吸衰竭和死亡的原因。开展了一项研究以确定夜间无创双水平压力支持通气（NIV）对重度高碳酸血症COPD患者的生存率、肺功能和生活质量的影响。

方法

在澳大利亚四所大学医院的睡眠/呼吸内科进行了一项多中心、开放标签、随机对照试验，比较NIV联合长期氧疗（LTOT）与单纯LTOT对重度稳定的吸烟相关COPD患者（1秒用力呼气容积（FEV1.0）<1.5升或<预测值的50%，FEV1.0与用力肺活量（FVC）之比<60%，清醒时动脉血二氧化碳分压（PaCO2）>46 mmHg且接受LTOT至少3个月）且年龄<80岁的患者的疗效。排除患有睡眠呼吸暂停（呼吸暂停低通气指数>20次/小时）或病态肥胖（体重指数>40）的患者。观察指标包括生存率、肺量计检查、动脉血气分析、多导睡眠图、一般和疾病特异性生活质量及情绪。

结果

144例患者被随机分组（72例接受NIV + LTOT，72例接受单纯LTOT）。NIV可迅速改善睡眠质量和与睡眠相关的高碳酸血症，患者对治疗的依从性良好（平均（标准差）每晚使用4.5（3.2）小时）。与单纯LTOT相比，NIV（平均随访2.21年，范围0.01 - 5.59年）在调整后的Cox模型中显示出生存率改善，但未调整的Cox模型中未显示（调整后的风险比（HR）0.63，95%可信区间0.40至0.99，p = 0.045；未调整的HR 0.82，95%可信区间0.53至1.25，p = 无统计学意义）。两组在6个月和12个月时测量的FEV1.0和PaCO2无差异。分配至NIV + LTOT组的患者一般健康、心理健康和活力降低。