Smyth J, Allen A, MacMurray B, Peliowski A, Sankaran K, Volberg F, Shukla A, Long W
British Columbia's Children's Hospital, Vancouver, Canada.
J Pediatr. 1995 May;126(5 Pt 2):S81-9. doi: 10.1016/s0022-3476(95)70012-9.
In a multicenter, double-masked, placebo-controlled rescue trial conducted at 12 Canadian hospitals, two 5 ml/kg doses of a synthetic surfactant or air placebo were administered to 224 infants with birth weights of 500 to 749 gm who had established respiratory distress syndrome and an arterial/alveolar oxygen tension ratio of less than 0.22. The first dose was given between 2 and 24 hours of age; the second dose was given 12 hours later to the infants continuing to receive mechanical ventilation. Infants were stratified at study entry by birth weight and gender. Infants receiving synthetic surfactant showed significant improvements in alveolar-arterial oxygen tension gradient, arterial/alveolar oxygen tension ratio, and oxygen and ventilator requirements through day 7. In the group randomized to synthetic surfactant, significant improvements were seen in oxygen requirements at the first time point measured (2 hours; p = 0.02), in the alveolar-arterial oxygen tension gradient by the second time point measured (6 hours; p = 0.03), and in mean airway pressure after 6 hours. Overall mortality at 28 days was not significantly different in the two groups (50% vs 46%, air placebo group vs synthetic surfactant group; p = 0.586). Similarly, neither the incidence of bronchopulmonary dysplasia (37% vs 30%, air placebo group vs synthetic surfactant group; p = 0.089) nor the incidence of survival without BPD through 28 days (17% vs 26%, respectively; p = 0.070) was significantly different in the two groups. No significant differences in the incidence of safety-related outcomes or in adverse effects such as apnea or pulmonary hemorrhage were noted. These findings indicate that rescue therapy with synthetic surfactant results in physiologic improvements in very tiny premature infants, but improvements in overall mortality or other complications of respiratory distress syndrome were not documented in the sample evaluated.
在加拿大12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，对224名出生体重为500至749克、已确诊为呼吸窘迫综合征且动脉/肺泡氧分压比小于0.22的婴儿，给予两剂5毫升/千克的合成表面活性剂或空气安慰剂。第一剂在出生后2至24小时内给予；12小时后，继续接受机械通气的婴儿给予第二剂。婴儿在研究入组时按出生体重和性别分层。接受合成表面活性剂的婴儿在第7天时，肺泡 - 动脉氧分压梯度、动脉/肺泡氧分压比以及氧气和呼吸机需求方面有显著改善。在随机接受合成表面活性剂的组中，在首次测量时间点（2小时；p = 0.02）氧气需求有显著改善，在第二个测量时间点（6小时；p = 0.03）肺泡 - 动脉氧分压梯度有显著改善，6小时后平均气道压有显著改善。两组28天的总体死亡率无显著差异（空气安慰剂组为50%，合成表面活性剂组为46%；p = 0.586）。同样，两组支气管肺发育不良的发生率（空气安慰剂组为37%，合成表面活性剂组为30%；p = 0.089）以及28天无支气管肺发育不良存活的发生率（分别为17%和26%；p = 0.070）均无显著差异。未观察到与安全性相关结局的发生率或呼吸暂停、肺出血等不良反应有显著差异。这些发现表明，用合成表面活性剂进行挽救性治疗可使极小的早产儿在生理上得到改善，但在所评估的样本中，未记录到呼吸窘迫综合征总体死亡率或其他并发症的改善情况。
