1 Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.
2 Department of Medical Statistics, Translational Research Informatics Center, Kobe, Japan.
Ann Am Thorac Soc. 2018 Apr;15(4):432-439. doi: 10.1513/AnnalsATS.201706-425OC.
A growing evidence base suggests a benefit of using high-flow nasal cannula oxygen therapy in the acute setting. However, the clinical benefit of domiciliary use of high-flow nasal cannula oxygen therapy in patients with chronic hypercapnic respiratory failure due to chronic obstructive pulmonary disease remains unclear.
To evaluate the efficacy and safety of high-flow nasal cannula oxygen therapy use in patients with stable chronic obstructive pulmonary disease.
We conducted a multicenter, randomized crossover trial comparing high-flow nasal cannula oxygen therapy plus long-term oxygen therapy with long-term oxygen therapy only in 32 adults with stable hypercapnic chronic obstructive pulmonary disease. Participants were randomized to receive either 6 weeks of high-flow nasal cannula oxygen therapy/long-term oxygen therapy using the myAIRVO 2 device followed by another 6 weeks of long-term oxygen therapy only or long-term oxygen therapy only followed by high-flow nasal cannula oxygen therapy/long-term oxygen therapy. The primary outcome was the change in quality of life as assessed by St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease. A linear mixed-effects model was used to account for treatment effect, time effect, allocation effect, and participant effect.
Of 32 study participants, 29 completed the study. At the end of 12 weeks, high-flow nasal cannula oxygen therapy/long-term oxygen therapy treatment improved the mean total St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease score compared with long-term oxygen therapy only (7.8 points; 95% confidence interval, 3.7 to 11.9; P < 0.01). Similarly, high-flow nasal cannula oxygen therapy/long-term oxygen therapy treatment improved the arterial partial pressure of carbon dioxide (adjusted treatment effect, -4.1 mm Hg; 95% confidence interval, -6.5 to -1.7 mm Hg), pH (adjusted treatment effect, +0.02; 95% confidence interval, 0.01 to 0.02), and median nocturnal transcutaneous carbon dioxide pressure (adjusted treatment effect, -5.1 mm Hg; 95% confidence interval, -8.4 to -1.8 mm Hg). High-flow nasal cannula oxygen therapy/long-term oxygen therapy treatment did not improve the arterial partial pressure of oxygen, dyspnea, spirometry, lung volume, 6-minute walk test, or physical activity. The most frequent high-flow nasal cannula oxygen therapy-related adverse event encountered was nocturnal sweating (n = 6 [20.7%]). Four severe adverse events occurred (two in each group) and were deemed unrelated to the intervention.
Six weeks of treatment with high-flow nasal cannula oxygen therapy improved health-related quality of life and reduced hypercapnia in patients with stable hypercapnic chronic obstructive pulmonary disease. Clinical trial registered with www.clinicaltrials.gov (NCT02545855) and www.umin/ac.jp (UMIN000017639).
越来越多的证据表明，高流量鼻导管氧疗在急性治疗中有一定益处。然而，对于慢性阻塞性肺疾病引起的慢性高碳酸血症呼吸衰竭患者，家庭使用高流量鼻导管氧疗的临床益处尚不清楚。
评估高流量鼻导管氧疗在稳定期慢性阻塞性肺疾病患者中的疗效和安全性。
我们进行了一项多中心、随机交叉试验，比较了高流量鼻导管氧疗联合长期氧疗与单纯长期氧疗对 32 例稳定期高碳酸血症慢性阻塞性肺疾病患者的影响。参与者被随机分配接受 6 周高流量鼻导管氧疗/长期氧疗（使用 myAIRVO 2 装置），然后再接受 6 周单纯长期氧疗，或单纯长期氧疗后再接受高流量鼻导管氧疗/长期氧疗。主要结局是采用慢性阻塞性肺疾病圣乔治呼吸问卷评估的生活质量变化。采用线性混合效应模型来解释治疗效果、时间效应、分配效应和个体效应。
在 32 名研究参与者中，有 29 名完成了研究。在 12 周结束时，与单纯长期氧疗相比，高流量鼻导管氧疗/长期氧疗治疗改善了慢性阻塞性肺疾病圣乔治呼吸问卷的总评分（7.8 分；95%置信区间，3.7 至 11.9；P<0.01）。同样，高流量鼻导管氧疗/长期氧疗治疗降低了动脉血二氧化碳分压（调整后的治疗效果，-4.1mmHg；95%置信区间，-6.5 至-1.7mmHg）、pH 值（调整后的治疗效果，+0.02；95%置信区间，0.01 至 0.02）和中位数夜间经皮二氧化碳分压（调整后的治疗效果，-5.1mmHg；95%置信区间，-8.4 至-1.8mmHg）。高流量鼻导管氧疗/长期氧疗治疗并未改善动脉血氧分压、呼吸困难、肺功能、6 分钟步行试验或体力活动。最常见的与高流量鼻导管氧疗相关的不良反应是夜间出汗（6 例[20.7%]）。共发生 4 例严重不良事件（每组 2 例），认为与干预无关。
6 周的高流量鼻导管氧疗治疗改善了稳定期高碳酸血症慢性阻塞性肺疾病患者的健康相关生活质量，并降低了高碳酸血症。临床试验在 www.clinicaltrials.gov（NCT02545855）和 www.umin.ac.jp（UMIN000017639）注册。
