Zhou Luqian, Li Xiaoying, Guan Lili, Chen Jianhua, Guo Bingpeng, Wu Weiliang, Huo Yating, Zhou Ziqing, Liang Zhenyu, Zhou Yuqi, Tan Jie, Chen Xin, Song Yuanlin, Chen Rongchang
Department of Respiratory Medicine, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University.
Department of Respiratory Medicine, The Third Affiliated Hospital of Sun-Yat Sen University.
Int J Chron Obstruct Pulmon Dis. 2017 Apr 27;12:1279-1286. doi: 10.2147/COPD.S127540. eCollection 2017.
The benefits of noninvasive positive pressure ventilation (NPPV) in patients with hypercapnic COPD are controversial. It is presumed that methodology and appropriate use of NIV ventilator might be crucial for the outcomes. With the new built-in software, the performance of NIV can be monitored at home, which can guarantee the compliance and appropriate use. This study investigated effects of home use of NIV in hypercapnia in COPD patients using the NIV ventilator with built-in software for monitoring.
The current multicenter prospective, randomized, controlled trial enrolled patients with stable GOLD stages III and IV hypercapnic COPD. Patients were randomly assigned via a computer-generated randomization sequence, with a block size of four patients, to continue optimized treatment (control group) or to receive additional NPPV (intervention group) for 3 months. The primary outcome was arterial carbon dioxide pressure (PaCO). Data were derived from built-in software and analyzed every 4 weeks. Analysis was carried out with the intention to treat. This study is registered with ClinicalTrials.gov, number NCT02499718.
Patients were recruited from 20 respiratory units in China from October 1, 2015, and recruitment was terminated with a record of the vital statistics on May 31, 2016. A total of 115 patients were randomly assigned to the NPPV group (n=57) or the control group (n=58). Patients complied well with NPPV therapy (mean [± standard deviation] day use 5.6±1.4 h). The mean estimation of leaks was 37.99±13.71 L/min. The changes in PaCO (-10.41±0.97 vs -4.32±0.68 mmHg, =0.03) and 6-min walk distance (6MWD) (38.2% vs 18.2%, =0.02) were statistically significant in the NPPV group versus the control group. COPD assessment test (CAT) showed a positive trend (=0.06) in favor of the NPPV group. Pulmonary function and dyspnea were not different between groups.
Ventilators equipped with built-in software provided methodology for monitoring NIV use at home, which could facilitate the improvement of compliance and quality control of NIV use. It was shown that three months use of NIV at home could reduce the PaCO and improve exercise tolerance (6MWD) in chronic hypercapnic COPD patients.
无创正压通气（NPPV）对高碳酸血症型慢性阻塞性肺疾病（COPD）患者的益处存在争议。据推测，无创通气（NIV）呼吸机的使用方法和恰当应用可能对治疗结果至关重要。借助新的内置软件，可在家中监测NIV的性能，这能确保依从性和恰当使用。本研究使用具有监测功能的内置软件的NIV呼吸机，调查在家中使用NIV对COPD高碳酸血症患者的影响。
当前这项多中心前瞻性随机对照试验纳入了稳定期GOLD III级和IV级高碳酸血症型COPD患者。通过计算机生成的随机序列，以4例患者为一组进行随机分组，患者被随机分配至继续优化治疗组（对照组）或接受额外NPPV组（干预组），为期3个月。主要结局指标为动脉血二氧化碳分压（PaCO）。数据源自内置软件，每4周进行分析。分析采用意向性分析。本研究已在ClinicalTrials.gov注册，注册号为NCT02499718。
2015年10月1日至2016年5月31日生命统计记录截止期间，从中国20个呼吸科单位招募患者。共115例患者被随机分配至NPPV组（n = 57）或对照组（n = 58）。患者对NPPV治疗依从性良好（平均[±标准差]每日使用5.6±1.4小时）。平均漏气估计值为37.99±13.71升/分钟。与对照组相比，NPPV组的PaCO变化（-10.41±0.97 vs -4.32±0.68 mmHg，P = 0.03）和6分钟步行距离（6MWD）变化（38.2% vs 18.2%，P = 0.02）具有统计学意义。COPD评估测试（CAT）显示有利于NPPV组的阳性趋势（P = 0.06）。两组间肺功能和呼吸困难无差异。
配备内置软件的呼吸机为在家中监测NIV使用提供了方法，有助于提高NIV使用的依从性和质量控制。结果表明，在家中使用3个月NIV可降低慢性高碳酸血症型COPD患者的PaCO并改善运动耐力（6MWD）。
