Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial
Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial
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DOI：
10.1016/s2213-2600(14)70153-5
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发表时间：
2014-09-01
影响因子：
76.2
通讯作者：
Welte, Tobias
中科院分区：
文献类型：
--
作者：
Koehnlein, Thomas;Windisch, Wolfram;Welte, Tobias
长期无创正压通气（NPPV）能够改善稳定期高碳酸血症慢性阻塞性肺疾病（COPD）患者生存率的证据不足。以前的前瞻性研究没有针对调整呼吸机设置时减少高碳酸血症。本研究调查了长期NPPV的效果，有针对性地显着减少高碳酸血症，对晚期，稳定的高碳酸血症的COPD.Methods患者的生存，这是一项由呼吸机启动的，前瞻性，多中心，随机，对照的临床试验，招募患者与稳定的GOLD IV期COPD和二氧化碳分压（PaCO 2）为7千帕（51.9毫米汞柱）或更高，pH值高于7-35。NPPV的目标是将基线PaCO 2降低至少20%或使PaCO 2值低于6.5 kPa（48.1 mm Hg）。患者通过计算机生成的随机序列（区组大小为4）随机分配（以1：1的比例），继续接受优化的标准治疗（对照组）或接受额外的NPPV至少12个月（干预组）。主要结局为1年全因死亡率。干预是非盲的，但结果评估对治疗分配是盲的。该研究注册于ClinicalTrials.gov，编号NCT 00710541。结果从2004年10月29日开始，从德国和奥地利的36个呼吸单位招募患者，并于2011年7月31日终止，记录生命状态。195例患者被随机分配到NPPV组（n=102）或对照组（n=93）。对照组和NPPV组的所有患者均纳入主要分析。1-干预组的年死亡率为12%（102名患者中的12名），对照组为33%（93名患者中的31名）;风险比0.24（95%CI 0.11-0.49; p=0.0004）。14例（14%）患者报告面部皮疹，可通过更换面罩类型进行管理。没有其他干预相关的不良事件的报道。解释长期NPPV标准治疗的增加提高了高碳酸血症，稳定的COPD患者的生存率时，NPPV的目标是大大减少高碳酸血症。
Background Evidence is weak for the ability of long-term non-invasive positive pressure ventilation (NPPV) to improve survival in patients with stable hypercapnic chronic obstructive pulmonary disease (COPD). Previous prospective studies did not target a reduction in hypercapnia when adjusting ventilator settings. This study investigated the effect of long-term NPPV, targeted to markedly reduce hypercapnia, on survival in patients with advanced, stable hypercapnic COPD.Methods This investigator-initiated, prospective, multicentre, randomised, controlled clinical trial enrolled patients with stable GOLD stage IV COPD and a partial carbon dioxide pressure (PaCO2) of 7 kPa (51.9 mm Hg) or higher and pH higher than 7-35. NPPV was targeted to reduce baseline PaCO2 by at least 20% or to achieve PaCO2 values lower than 6.5 kPa (48.1 mm Hg). Patients were randomly assigned (in a 1:1 ratio) via a computer-generated randomisation sequence with a block size of four, to continue optimised standard treatment (control group) or to receive additional NPPV for at least 12 months (intervention group). The primary outcome was 1-year all-cause mortality. Analysis was by intention to treat. The intervention was unblinded, but outcome assessment was blinded to treatment assignment. This study is registered with ClinicalTrials.gov, number NCT00710541.Findings Patients were recruited from 36 respiratory units in Germany and Austria, starting on Oct 29, 2004, and terminated with a record of the vital status on July 31, 2011. 195 patients were randomly assigned to the NPPV group (n=102) or to the control group (n=93). All patients from the control group and the NPPV group were included in the primary analysis. 1-year mortality was 12% (12 of 102 patients) in the intervention group and 33% (31 of 93 patients) in the control group; hazard ratio 0.24 (95% CI 0.11-0.49; p=0.0004). 14 (14%) patients reported facial skin rash, which could be managed by changing the type of the mask. No other intervention-related adverse events were reported.Interpretation The addition of long-term NPPV to standard treatment improves survival of patients with hypercapnic, stable COPD when NPPV is targeted to greatly reduce hypercapnia.