From Sorbonne Université INSERM Unité Mixte de Recherche (UMRS) 1166, Institute of Cardiometabolism and Nutrition (A.C., G.L.), Service de Médecine Intensive-Réanimation, Institut de Cardiologie, Assistance Publique-Hôpitaux de Paris (APHP) Hôpital Pitié-Salpêtrière (A.C.), Département de Biostatistiques, Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie, APHP Hôpital Pitié-Salpêtrière (D.H.), Sorbonne Université, Unité de Recherche Clinique Pitié-Salpêtrière (D.H.), Sorbonne Université INSERM UMRS 1158 (A.D.), Service de Médecine Intensive-Réanimation et Pneumologie, APHP Hôpital Pitié-Salpêtrière (A.D.), Service de Médecine Intensive et Réanimation, Centre Hospitalier Universitaire (CHU) Saint Louis (L.Z.), Service de Médecine Intensive et Réanimation, CHU Saint Antoine (E.M.), Service de Médecine Intensive et Réanimation, APHP Bichat Hospital, Diderot University (L. Bouadma), and Service de Chirurgie Thoracique et Cardiovasculaire, APHP Hôpital Pitié-Salpêtrière, Institut de Cardiologie (G.L.), Paris, Service de Médecine Intensive et Réanimation, Besançon University Hospital, and Research Unit Equipe Avenir 3920 and Structure Fédérative de Recherche 4234, University of Franche Comté, Besançon (G.C.), Service de Médecine Intensive et Réanimation, CHU Pontchaillou, Rennes (S.L.), Service de Médecine Intensive et Réanimation, CHU Hôpital Nord, APHM, Marseille (C.G.), Service de Médecine Intensive et Réanimation, CHU Saint Denis, Saint Denis (D.D.S.), Service de Médecine Intensive et Réanimation, CHU Le Mans, Le Mans (P.T.), Département d'Anesthésie et Réanimation, CHU de Rouen (B.V.), Service de Médecine Intensive et Réanimation, Rouen University Hospital (G.B.), and Normandie University, Université de Rouen, Equipe Avenir 3830, Rouen University Hospital (G.B.), Rouen, Service de Médecine Intensive et Réanimation, CHU Nancy and INSERM Unité 1116, Université de Lorraine, Nancy (B.L.), Service de Médecine Intensive et Réanimation, CHU Avicenne, Bobigny (Y.C.), Service de Médecine Intensive et Réanimation, CHU Kremlin Bicêtre, Le Kremlin Bicêtre (C.R.), Service de Réanimation Polyvalente, Hôpital de Chartres, Chartres (P.K.), CHU Martinique, Fort-de-France (H.M.), and Service de Médecine Intensive et Réanimation, Centre Hospitalier Universitaire d'Angers, Université d'Angers, Angers (A.M.) - all in France; the Interdepartmental Division of Critical Care Medicine, Departments of Medicine and Physiology, Institute for Health Management, Policy, and Evaluation, University of Toronto (L. Brochard, N.D.F., E.F.), Keenan Research Center, Li Ka Shing Knowledge Institute, St. Michael's Hospital (L. Brochard, A.S.S.), and the Department of Medicine, Division of Respirology, University Health Network and Sinai Health System, Toronto General Hospital (N.D.F., E.F.), Toronto; and the Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University Medical Center, and New York-Presbyterian Hospital, Columbia University, New York (D.B.).
N Engl J Med. 2018 May 24;378(21):1965-1975. doi: 10.1056/NEJMoa1800385.
BACKGROUND: The efficacy of venovenous extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory distress syndrome (ARDS) remains controversial. METHODS: 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 (Pao) to the fraction of inspired oxygen (Fio) of less than 50 mm Hg for more than 3 hours; a Pao:Fio 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. RESULTS: 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). CONCLUSIONS: 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. (Funded by the Direction de la Recherche Clinique et du Développement and the French Ministry of Health; EOLIA ClinicalTrials.gov number, NCT01470703 .).
背景：静脉-静脉体外膜肺氧合（ECMO）在严重急性呼吸窘迫综合征（ARDS）患者中的疗效仍存在争议。
方法：在一项国际临床试验中，我们将符合以下三个标准之一的非常严重的 ARDS 患者随机分为两组：动脉血氧分压（Pao）与吸入氧分数（Fio）比值持续 3 小时以上小于 50mmHg；Pao:Fio 比值持续 6 小时以上小于 80mmHg；或动脉血 pH 值持续 6 小时以上小于 7.25 且动脉血二氧化碳分压至少 60mmHg - 接受立即静脉-静脉 ECMO（ECMO 组）或继续常规治疗（对照组）。对照组中出现难治性低氧血症的患者可以交叉至 ECMO 治疗。主要终点为 60 天死亡率。
结果：60 天时，ECMO 组 124 例患者中有 44 例（35%），对照组 125 例患者中有 57 例（46%）死亡（相对风险，0.76；95%置信区间[CI]，0.55 至 1.04；P=0.09）。对照组中有 35 例（28%）患者在随机分组后平均（±SD）6.5±9.7 天交叉至 ECMO 治疗，其中 20 例（57%）死亡。两组并发症发生率无显著差异，但 ECMO 组出血事件导致输血的发生率高于对照组（分别为 46%和 28%的患者；绝对风险差异，18 个百分点；95%CI，6 至 30），且严重血小板减少症的发生率也高于对照组（分别为 27%和 16%的患者；绝对风险差异，11 个百分点；95%CI，0 至 21），而缺血性卒中的发生率则低于对照组（分别为 0%和 5%的患者；绝对风险差异，-5 个百分点；95%CI，-10 至-2）。
结论：在非常严重的 ARDS 患者中，与包括 ECMO 作为抢救治疗的常规机械通气策略相比，60 天死亡率并未显著降低。（由临床研究与发展局和法国卫生部资助；EOLIA ClinicalTrials.gov 编号，NCT01470703）。
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