In a randomized multicenter trial, involving the collaboration of eight European neonatal intensive care units, the efficacy of replacement therapy with a new surfactant preparation (Curosurf) was tested in 146 patients with severe neonatal respiratory distress syndrome. Criteria for entry included birth weight 700 to 2,000 g, age when treated two to 15 hours, and requirement of artificial ventilation with Fio2 ≥ 0.6. The babies were treated with a single large dose of surfactant (200 mg/kg) at a median age of nine hours (range two to 15 hours). Average Fio2 before treatment was the same (0.80) for both surfactant-treated patients and control patients. Babies receiving surfactant showed, within five minutes, a dramatic improvement of oxygenation as reflected by a nearly threefold increase of the Pao2/Fio2 ratio. Six hours after randomization, the Pao2/Fio2 ratio still showed a 98% improvement in surfactant-treated patients compared with controls ( P .001), and statistically significant differences in favor of the treated babies persisted until 48 hours after randomization, when surviving control infants began to recover. Treatment with surfactant decreased neonatal (≤28 days) mortality from 51% to 31% ( P .05). Compared with control babies, the surfactant-treated group also had a decreased incidence of pulmonary interstitial emphysema (23% v 39%; P .05) and pneumothorax (18% v 35%; P .05). The percentage of survivors without bronchopulmonary dysplasia in the treated group was more than twice that of the control group (55% v 26%; P .001). Treatment with this surfactant appears to effectively improve lung function and short-term outcome in infants with severe respiratory distress syndrome.
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机译：在一项涉及八个欧洲新生儿重症监护病房的合作的随机多中心试验中，在146例严重的新生儿呼吸窘迫综合征患者中测试了用新型表面活性剂制剂（Curosurf）替代治疗的疗效。进入标准包括出生体重700至2,000 g，治疗2至15小时的年龄以及Fio2≥0.6的人工通气的要求。在中位年龄为9个小时（2到15个小时）的情况下，用一次大剂量的表面活性剂（200 mg / kg）对婴儿进行了治疗。对于表面活性剂治疗的患者和对照组，治疗前的平均Fio2相同（0.80）。接受表面活性剂的婴儿在五分钟内显示出氧合的显着改善，这表现为Pao2 / Fio2比值增加了近三倍。随机分组后六个小时，经表面活性剂治疗的患者与对照组相比，Pao2 / Fio2的比例仍显示出98％的改善（P <.001），在随机分组后的48小时内，存活的存活婴儿的统计学意义上的显着差异持续存在对照婴儿开始康复。用表面活性剂治疗将新生儿（≤28天）死亡率从51％降低到31％（P <.05）。与对照组婴儿相比，表面活性剂治疗组的肺间质性肺气肿（23％v 39％; P <.05）和气胸（18％v 35％; P <.05）的发生率也降低。治疗组中没有支气管肺发育不良的幸存者的百分比是对照组的两倍以上（55％对26％; P <.001）。用这种表面活性剂治疗似乎可以有效改善患有严重呼吸窘迫综合征的婴儿的肺功能和短期预后。
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