O'Rourke P P, Crone R K, Vacanti J P, Ware J H, Lillehei C W, Parad R B, Epstein M F
Department of Anesthesia, Children's Hospital, Harvard Medical School, Boston, Massachusetts 02115.
Pediatrics. 1989 Dec;84(6):957-63.
Thirty-nine newborn infants with severe persistent pulmonary hypertension and respiratory failure who met criteria for 85% likelihood of dying were enrolled in a randomized trial in which extracorporeal membrane oxygenation (ECMO) therapy was compared with conventional medical therapy (CMT). In phase I, 4 of 10 babies in the CMT group died and 9 of 9 babies in the ECMO group survived. Randomization was halted after the fourth CMT death, as planned before initiating the study, and the next 20 babies were treated with ECMO (phase II). Of the 20, 19 survived. All three treatment groups (CMT and ECMO in phase I and ECMO, phase II) were comparable in severity of illness and mechanical ventilator support. The overall survival of ECMO-treated infants was 97% (28 of 29) compared with 60% (6 of 10) in the CMT group (P less than .05).
39名患有严重持续性肺动脉高压和呼吸衰竭且死亡可能性达85%的新生儿被纳入一项随机试验，该试验将体外膜肺氧合（ECMO）疗法与传统药物治疗（CMT）进行比较。在第一阶段，CMT组10名婴儿中有4名死亡，ECMO组9名婴儿全部存活。如研究开始前计划的那样，在CMT组第4例死亡后停止随机分组，接下来的20名婴儿接受ECMO治疗（第二阶段）。这20名婴儿中有19名存活。所有三个治疗组（第一阶段的CMT组和ECMO组以及第二阶段的ECMO组）在疾病严重程度和机械通气支持方面具有可比性。接受ECMO治疗的婴儿总体存活率为97%（29例中的28例），而CMT组为60%（10例中的6例）（P<0.05）。
