早期应用无创正压通气治疗慢性阻塞性肺疾病急性加重期患者的多中心随机对照研究

Early use of noninvasive positive pressure ventilation for patients with acute exacerbations of chronic obstructive pulmonary disease:a multicentre randomized controlled trial

目的评价在普通病房早期应用无创正压通气(NPPV)治疗慢性阻塞性肺疾病急性加重(AECOPD)患者的有效性与安全性,确立其临床应用指征.方法 19家医院入住普通病房24～48 h内的AECOPD患者[pH值≥7.25,且动脉血二氧化碳分压(PaCO2)＞45 mm Hg,1 mm Hg=0.133 kPa]根据中心随机的方式分配到常规治疗组(A组)和常规治疗组+NPPV治疗组(B组),观察指标包括呼吸频率(RR)、辅助呼吸肌评分、动脉血气、后期气管插管需求率(简称插管率)和住院病死率等.结果 AECOPD患者342例,A组(171例)与B组(171例)的基础情况匹配良好(P均＞0.05).B组后期插管率(4.7%,8/171)显著低于A组(15.2%,26/171,P=0.002).根据pH值分层研究显示,B组轻度通气功能障碍(pH值≥7.35)、较重通气功能障碍(pH值＜7.30)患者的插管率[2.8%(2/71)、7.0%(3/43)]显著低于A组[11.3%(9/80)、26.7%(8/30),P=0.047、0.048].B组病死率[2.8%(7/171)]与A组[7.0%(12/171)]比较差异无统计学意义(P=0.345).B组实施NPPV 2 h后即能显著改善患者的动脉血pH值、降低RR、减少辅助呼吸肌的参与,且24 h后其pH值、动脉血氧分压(PaO2)、辅助呼吸肌评分、RR[7.36±0.06、(72±22)mm Hg、2.5±0.9、(22±4)次/min]与A组[7.37±0.05、(85±34)mm Hg、2.3±1.1、(21±4)次/min]比较差异均有统计学意义(P均＜0.01).结论入院早期在普通病房应用NPPV能改善AECOPD患者的病理生理状况,减少插管率;NPPV在缓解呼吸肌疲劳及预防呼吸衰竭的加重方面有其应用指征.

Objective To assess the efficacy and safety of noninvasive positive pressure ventilation （NPPV） for acute exacerbations of chronic obstructive pulmonary disease （AECOPD）patients on general wards. Methods A prospective multicentre randomized controlled trial was conducted in 19 hospitals in China over 16 months. 342 AECOPD patients with pH≥7. 25 and arterial partial pressure of carbon dioxide （PaCO2） 〉45 mm Hg （1 mm Hg =0. 133 kPa）were recruited on general wards and randomly assigned to standard medical treatment （group A, n = 171 ） or early administration of NPPV plus standard medical treatment （group B, n = 171 ）. Results The characteristics of the two groups on admission were similar. The number of AECOPD patients requiring intubations in group B was significantly less than that of the group A （8/171,26/71, P = 0. 002）. Subgroup analysis showed the need for intubation in both the mild （pH≥7.35 ） and the severe（pH 〈 7.30） acidotic patients in group B were decreased （9/80,2/71, P = 0. 047 and 8/30, 3/43, P = 0. 048 respectively ）. The mortality in hospital was reduced slightly by NPPV but with no significant difference（7/171,12/171, P = 0. 345 ）. Respiratory rate （ RR ）, scale for accessory muscle use and arterial pH improved rapidly at the first 2 hours only in patients of group B. After 24 hours, the differences of pH, arterial partial pressure of oxygen（ PaO2 ）, scale for accessory muscle use and RR in group B [ 7. 36 ± 0. 06, （72 ± 22 ） mm Hg, 2. 5 ± 0. 9, （22 ± 4 ）/min ] were statistically significant compared with group A [ 7. 37±0.05,（85±34）mm Hg,2.3 ± 1.1,（21±4）/min, P 〈0.01 for all comparisons]. Conclusions The early use of NPPV on general wards improves arterial blood gas and respiratory pattern, decreases the rate of need for intubation in AECOPD patients. NPPV is indicative for alleviating respiratory muscle fatigue and preventing respiratory failure from exacerbation.