ORIGINAL ARTICLE
Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome
Alain Combes, David Hajage, Gilles Capellier, et al
N Engl J Med 2018; 378:1965-1975
DOI: 10.1056/NEJMoa1800385
Abstract
BACKGROUND 背景
The efficacy of venovenous extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory distress syndrome (ARDS) remains controversial.
vvECMO对严重ARDS患者的疗效仍存在争议。
METHODS 方法
In an international clinical trial, we randomly assigned patients with very severe ARDS, as indicated by one of three criteria — a ratio of partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) of less than 50 mm Hg for more than 3 hours; a Pao2:Fio2 of less than 80 mm Hg for more than 6 hours; or an arterial blood pH of less than 7.25 with a partial pressure of arterial carbon dioxide of at least 60 mm Hg for more than 6 hours — to receive immediate venovenous ECMO (ECMO group) or continued conventional treatment (control group). Crossover to ECMO was possible for patients in the control group who had refractory hypoxemia. The primary end point was mortality at 60 days.
在这项国际临床试验中，我们将极危重的ARDS患者（满足以下三条标准中的一条：PaO2/FiO2 < 50 mmHg持续超过3小时；PaO2/FiO2 < 80 mmHg持续超过6小时；或动脉血pH < 7.25，PaCO2 > 60 mmHg超过6小时）随机分组，立即接受vvECMO治疗（ECMO组）或继续传统治疗（对照组）。对照组患者若有顽固性低氧血症，可交叉接受ECMO治疗。主要预后终点为60天病死率。
RESULTS 结果
At 60 days, 44 of 124 patients (35%) in the ECMO group and 57 of 125 (46%) in the control group had died (relative risk, 0.76; 95% confidence interval [CI], 0.55 to 1.04; P=0.09). Crossover to ECMO occurred a mean (±SD) of 6.5±9.7 days after randomization in 35 patients (28%) in the control group, with 20 of these patients (57%) dying. The frequency of complications did not differ significantly between groups, except that there were more bleeding events leading to transfusion in the ECMO group than in the control group (in 46% vs. 28% of patients; absolute risk difference, 18 percentage points; 95% CI, 6 to 30) as well as more cases of severe thrombocytopenia (in 27% vs. 16%; absolute risk difference, 11 percentage points; 95% CI, 0 to 21) and fewer cases of ischemic stroke (in no patients vs. 5%; absolute risk difference, −5 percentage points; 95% CI, −10 to −2).
60天时，ECMO组124例患者中44例(35%)死亡，对照组125例患者中57例(46%)死亡（相对危险度0.76；95% 可信限 [CI], 0.55 to 1.04; P=0.09）。对照组中35例(28%)患者于随机分组后 6.5±9.7 天交叉接受ECMO治疗，其中20例(57%)死亡。ECMO组患者需要输血的出血事件较对照组更多 (46% vs. 28%；绝对风险差异，18%；95% CI, 6 to 30），严重血小板缺乏病例更多（27% vs. 16%; 绝对风险差异， 11%; 95% CI, 0 to 21），缺血性卒中比例较低（0 vs. 5%；绝对风险差异，−5%；95% CI, −10 to −2）。此外，两组患者并发症发生率无显著差异。
CONCLUSIONS 结论
Among patients with very severe ARDS, 60-day mortality was not significantly lower with ECMO than with a strategy of conventional mechanical ventilation that included ECMO as rescue therapy.
对于极为严重的ARDS患者，与将ECMO作为挽救治疗的传统机械通气治疗策略相比，ECMO治疗不能显著降低60天病死率。
(Funded by the Direction de la Recherche Clinique et du Développement and the French Ministry of Health; EOLIA ClinicalTrials.gov number, NCT01470703.)
