Delclaux C, L'Her E, Alberti C, Mancebo J, Abroug F, Conti G, Guérin C, Schortgen F, Lefort Y, Antonelli M, Lepage E, Lemaire F, Brochard L
Service de Réanimation Médicale, Hôpital Henri Mondor, 94010 Créteil, France.
JAMA. 2000 Nov 8;284(18):2352-60. doi: 10.1001/jama.284.18.2352.
Continuous positive airway pressure (CPAP) is widely used in the belief that it may reduce the need for intubation and mechanical ventilation in patients with acute hypoxemic respiratory insufficiency.
To compare the physiologic effects and the clinical efficacy of CPAP vs standard oxygen therapy in patients with acute hypoxemic, nonhypercapnic respiratory insufficiency.
DESIGN, SETTING, AND PATIENTS: Randomized, concealed, and unblinded trial of 123 consecutive adult patients who were admitted to 6 intensive care units between September 1997 and January 1999 with a PaO(2)/FIO(2) ratio of 300 mm Hg or less due to bilateral pulmonary edema (n = 102 with acute lung injury and n = 21 with cardiac disease).
Patients were randomly assigned to receive oxygen therapy alone (n = 61) or oxygen therapy plus CPAP (n = 62).
Improvement in PaO(2)/FIO(2) ratio, rate of endotracheal intubation at any time during the study, adverse events, length of hospital stay, mortality, and duration of ventilatory assistance, compared between the CPAP and standard treatment groups.
Among the CPAP vs standard therapy groups, respectively, causes of respiratory failure (pneumonia, 54% and 55%), presence of cardiac disease (33% and 35%), severity at admission, and hypoxemia (median [5th-95th percentile] PaO(2)/FIO(2) ratio, 140 [59-288] mm Hg vs 148 [62-283] mm Hg; P =.43) were similarly distributed. After 1 hour of treatment, subjective responses to treatment (P<.001) and median (5th-95th percentile) PaO(2)/FIO(2) ratios were greater with CPAP (203 [45-431] mm Hg vs 151 [73-482] mm Hg; P =.02). No further difference in respiratory indices was observed between the groups. Treatment with CPAP failed to reduce the endotracheal intubation rate (21 [34%] vs 24 [39%] in the standard therapy group; P =.53), hospital mortality (19 [31%] vs 18 [30%]; P =.89), or median (5th-95th percentile) intensive care unit length of stay (6.5 [1-57] days vs 6.0 [1-36] days; P =.43). A higher number of adverse events occurred with CPAP treatment (18 vs 6; P =.01).
In this study, despite early physiologic improvement, CPAP neither reduced the need for intubation nor improved outcomes in patients with acute hypoxemic, nonhypercapnic respiratory insufficiency primarily due to acute lung injury. JAMA. 2000;284:2352-2360.
持续气道正压通气（CPAP）被广泛应用，人们认为它可能减少急性低氧性呼吸功能不全患者的气管插管和机械通气需求。
比较CPAP与标准氧疗对急性低氧性、非高碳酸血症性呼吸功能不全患者的生理效应和临床疗效。
设计、地点和患者：1997年9月至1999年1月期间，对连续入住6个重症监护病房的123例成年患者进行随机、隐蔽且非盲法试验，这些患者因双侧肺水肿导致动脉血氧分压（PaO₂）/吸入氧分数值（FIO₂）比值≤300 mmHg（急性肺损伤患者102例，心脏病患者21例）。
患者被随机分配接受单纯氧疗（n = 61）或氧疗加CPAP（n = 62）。
比较CPAP组和标准治疗组之间PaO₂/FIO₂比值的改善情况、研究期间任何时间的气管插管率、不良事件、住院时间、死亡率以及通气辅助时间。
CPAP组与标准治疗组相比，呼吸衰竭原因（肺炎，分别为54%和55%）、心脏病的存在情况（33%和35%）、入院时的严重程度以及低氧血症（中位数[第5 - 95百分位数]PaO₂/FIO₂比值，140[59 - 288]mmHg对148[62 - 283]mmHg；P = 0.43）分布相似。治疗1小时后，CPAP治疗的主观反应（P<0.001）和中位数（第5 - 95百分位数）PaO₂/FIO₂比值更高（203[45 - 431]mmHg对151[73 - 482]mmHg；P = 0.02）。两组之间未观察到呼吸指标的进一步差异。CPAP治疗未能降低气管插管率（标准治疗组为24例[39%]，CPAP组为21例[34%]；P = 0.53）、医院死亡率（分别为18例[30%]和19例[31%]；P = 0.89）或中位数（第5 - 95百分位数）重症监护病房住院时间（6.5[1 - 57]天对6.0[1 - 36]天；P = 0.43）。CPAP治疗出现的不良事件更多（18例对6例；P = 0.01）。
在本研究中，尽管早期生理状况有所改善，但CPAP既未减少急性低氧性、非高碳酸血症性呼吸功能不全（主要由急性肺损伤引起）患者的气管插管需求，也未改善其预后。《美国医学会杂志》。2000年；284:2352 - 2360。
