Berry D D, Pramanik A K, Philips J B, Buchter D S, Kanarek K S, Easa D, Kopelman A E, Edwards K, Long W
Department of Pediatrics, Bowman Gray School of Medicine, Winston-Salem, NC 27157.
J Pediatr. 1994 Feb;124(2):294-301. doi: 10.1016/s0022-3476(94)70323-x.
The effect of a 50% increment or decrement in the recommended 5 ml/kg dose of a commercially available surfactant (Exosurf Neonatal) on the alveolar-arterial oxygen gradient was investigated in a multicenter, double-blind, placebo-controlled rescue trial conducted at 15 hospitals in the United States. Two doses of three different volumes (2.5, 5.0, and 7.5 ml/kg) were compared with two 5.0 ml/kg doses of air in 281 infants weighing > or = 1250 gm who had respiratory distress syndrome requiring mechanical ventilation and an arterial/alveolar oxygen ratio < 0.22. The first dose was given between 2 and 24 hours of age, and the second dose was given 12 hours later to all infants who still required mechanical ventilation. Infants were stratified at entry by gender and the magnitude of the arterial/alveolar oxygen ratio. The air placebo arm of the study was terminated early when reductions in mortality rates were proved in another rescue trial of this surfactant in infants with the same birth weights. For the first 48 hours, administration of a 2.5 ml/kg dose of surfactant provided less improvement in the alveolar-arterial oxygen gradient than doses of 5.0 and 7.5 ml/kg, which were equivalent. Similar results were observed in mean airway pressure (p < 0.05). There were no significant differences among the three dosage groups in mortality rate, air leak, bronchopulmonary dysplasia, and other complications of prematurity. There were no pulmonary hemorrhages in any group. Reflux of surfactant occurred more frequently in the 5.0 and 7.5 ml/kg groups. These results indicate that more sustained improvements in oxygenation are provided, with equal safety, by the standard two 5.0 ml/kg rescue doses of this surfactant than by the 2.5 ml/kg dose. No further benefit is gained from two larger doses given 12 hours apart.
在美国15家医院进行的一项多中心、双盲、安慰剂对照的挽救性试验中，研究了将市售表面活性剂（固尔苏）推荐剂量5 ml/kg增加或减少50%对肺泡-动脉氧梯度的影响。将三种不同体积（2.5、5.0和7.5 ml/kg）的两种剂量与281名体重≥1250克、患有呼吸窘迫综合征需要机械通气且动脉/肺泡氧比值<0.22的婴儿的两种5.0 ml/kg空气剂量进行比较。第一剂在出生后2至24小时内给予，第二剂在12小时后给予所有仍需要机械通气的婴儿。婴儿在入组时按性别和动脉/肺泡氧比值大小分层。当在另一项针对相同出生体重婴儿的该表面活性剂挽救性试验中证明死亡率降低时，该研究的空气安慰剂组提前终止。在最初的48小时内，给予2.5 ml/kg剂量的表面活性剂在肺泡-动脉氧梯度方面的改善不如5.0和7.5 ml/kg剂量，后两者效果相当。平均气道压力也观察到类似结果（p<0.05）。三个剂量组在死亡率、气漏、支气管肺发育不良和其他早产并发症方面无显著差异。任何组均未发生肺出血。表面活性剂反流在5.0和7.5 ml/kg组中更频繁发生。这些结果表明，与2.5 ml/kg剂量相比，该表面活性剂标准的两剂5.0 ml/kg挽救剂量能提供更持续的氧合改善，且安全性相同。间隔12小时给予两剂更大剂量并无进一步益处。
