Zola E M, Gunkel J H, Chan R K, Lim M O, Knox I, Feldman B H, Denson S E, Stonestreet B S, Mitchell B R, Wyza M M
Ross Laboratories Division of Abbott Laboratories, Columbus, Ohio 43215.
J Pediatr. 1993 Mar;122(3):453-9. doi: 10.1016/s0022-3476(05)83440-7.
A multicenter, randomized, double-blind, controlled trial compared three beractant (Survanta) administration procedures in the treatment of neonatal respiratory distress syndrome. Infants weighing > or = 600 gm with respiratory distress syndrome who required assisted ventilation were treated within 8 hours of birth with beractant administered intratracheally. Procedure A required administration in two fractional doses after removal of the infant from the ventilator. Procedure B required administration in two fractional doses through a neonatal suction valve and did not require removal of the infant from the ventilator, and procedure C required administration in four fractional doses during removal from the ventilator. Procedure C is the method used in all previous beractant studies. Of the 299 infants enrolled, 103 were randomly assigned to procedure A, 100 to procedure B, and 96 to procedure C. The results indicate no significant differences among the treatment groups in the clinical outcome measures of fractional inspired oxygen, mean airway pressure, and arterial-alveolar ratio of partial pressure of oxygen at 72 hours of life, or in the incidences of air leaks, pulmonary interstitial emphysema, or death through 72 hours of life. There were no significant differences in the lowest heart rates recorded during administration of doses, but there was less oxygen desaturation during administration of dose 1 with procedure B than with procedure A (p = 0.001), and more reflux of beractant after procedure B than after procedure C (p = 0.007). We conclude that the three procedures are equally effective and can be used to administer beractant safely and effectively. Procedure B has the advantage of allowing administration without interrupting mechanical ventilation.
一项多中心、随机、双盲、对照试验比较了三种贝拉克坦（固尔苏）给药程序在治疗新生儿呼吸窘迫综合征中的效果。体重≥600克且患有呼吸窘迫综合征、需要辅助通气的婴儿在出生后8小时内接受经气管内给予的贝拉克坦治疗。程序A要求在将婴儿从呼吸机上移除后分两次给予药物。程序B要求通过新生儿吸引阀分两次给予药物，且不需要将婴儿从呼吸机上移除，程序C要求在从呼吸机上移除过程中分四次给予药物。程序C是之前所有贝拉克坦研究中使用的方法。在纳入的299名婴儿中，103名被随机分配至程序A，100名至程序B，96名至程序C。结果表明，在出生后72小时时，各治疗组在吸入氧分数、平均气道压力以及动脉血氧分压与肺泡氧分压比值等临床结局指标方面，或在72小时内的气胸、肺间质气肿或死亡发生率方面，均无显著差异。给药期间记录的最低心率无显著差异，但程序B在给予第1剂药物时的氧饱和度下降情况比程序A少（p = 0.001），且程序B给药后的贝拉克坦反流比程序C多（p = 0.007）。我们得出结论，这三种程序同样有效，可安全有效地用于给予贝拉克坦。程序B的优点是无需中断机械通气即可给药。
