Lotze A, Knight G R, Martin G R, Bulas D I, Hull W M, O'Donnell R M, Whitsett J A, Short B L
Department of Neonatology, George Washington University School of Medicine and Health Sciences, Washington, D.C.
J Pediatr. 1993 Feb;122(2):261-8. doi: 10.1016/s0022-3476(06)80131-9.
A blinded, randomized, controlled study was designed to test whether multiple-dose surfactant therapy would improve pulmonary outcome in term infants with respiratory failure, resulting in a shortened period of extracorporeal membrane oxygenation (ECMO). Infants > or = 34 weeks of gestational age in severe respiratory failure and receiving ECMO were stratified by diagnosis and then randomly assigned to the treatment or the control group. Four doses of modified bovine lung surfactant extract (beractant) were administered to the surfactant group (n = 28), and an equal volume of air was administered to the control group (n = 28). Lung compliance was initially low in both groups; after treatment, values were higher with time in the surfactant group (F = 5.40, p = 0.026). The ECMO treatment period was significantly shorter in the surfactant group (mean +/- SD: 107 +/- 33 hours vs 139 +/- 54 hours for the control group; U = 232, p = 0.023). Tracheal aspirate concentrations of surfactant protein A were low in both groups, and then increased steadily to a higher level in the surfactant group (F = 2.58, p = 0.04). The overall incidence of complications after ECMO was decreased in the surfactant group (18% vs 46% for the control group; chi-square value = 5.004, p = 0.025). Radiographic scores, echocardiographic findings, incidence of intracranial or pulmonary hemorrhage and bronchopulmonary dysplasia, time to extubation, duration of oxygen therapy, and duration of hospitalization did not differ between the two groups. Beractant in this population improved pulmonary mechanics, increased surfactant protein A content in tracheal aspirate, decreased time on ECMO duration, and reduced disease complications.
一项设盲、随机、对照研究旨在测试多剂量表面活性剂疗法是否能改善足月呼吸衰竭婴儿的肺部预后，从而缩短体外膜肺氧合（ECMO）治疗时间。孕周≥34周且患有严重呼吸衰竭并接受ECMO治疗的婴儿按诊断进行分层，然后随机分为治疗组或对照组。给表面活性剂组（n = 28）给予四剂改良牛肺表面活性剂提取物（固尔苏），给对照组（n = 28）给予等量空气。两组最初肺顺应性均较低；治疗后，表面活性剂组的值随时间升高（F = 5.40，p = 0.026）。表面活性剂组的ECMO治疗时间显著缩短（均值±标准差：107±33小时，对照组为139±54小时；U = 232，p = 0.023）。两组气管吸出物中表面活性蛋白A的浓度均较低，随后表面活性剂组稳步升高至更高水平（F = 2.58，p = 0.04）。表面活性剂组ECMO后并发症的总体发生率降低（18%，对照组为46%；卡方值 = 5.004，p = 0.025）。两组间的影像学评分、超声心动图结果、颅内或肺出血及支气管肺发育不良的发生率、拔管时间、氧疗持续时间和住院时间无差异。固尔苏在该人群中改善了肺力学，增加了气管吸出物中表面活性蛋白A的含量，缩短了ECMO持续时间，并减少了疾病并发症。
