Double-blind, randomized trial of a calf lung surfactant extract administered at birth to very premature infants for prevention of respiratory distress syndrome.
Double-blind, randomized trial of a calf lung surfactant extract administered at birth to very premature infants for prevention of respiratory distress syndrome.
复制标题
对早产儿出生时给予小牛肺表面活性剂提取物预防呼吸窘迫综合征的双盲、随机试验。
作者：
D. L. Shapiro;Robert H. Notter;Frederick C Morin;K. S. Deluga;Leonard M. Golub;R. Sinkin;Kerry Weiss;Christopher Cox
小牛肺灌洗获得的表面活性剂的有机溶剂萃取产生高度表面活性的材料。1983年12月，在罗切斯特大学的新生儿重症监护室开始了一项双盲、随机临床试验，以确定该材料对早产儿呼吸窘迫综合征的影响。胎龄25 - 29周的婴儿有资格进入试验。在进行中期分析时，随机选择了32名患者进入试验，其中16名接受表面活性剂治疗，16名为对照组，仅接受生理盐水治疗。出生时，在插管后和通气前，立即在产房内将小牛肺表面活性物质提取物分散在盐水或盐水中进行肺内滴注;然后对婴儿进行通气并照常治疗。在出生后6、12、24、48和72小时，根据氧气和平均气道压力要求，将呼吸窘迫的严重程度分类为轻微、中度或重度。在出生后6小时观察到的差异具有边缘意义，但在12和24小时，与对照组相比，表面活性剂治疗组的严重呼吸窘迫明显减轻（P <0.01）。在出生后48和72小时，治疗组和对照组婴儿之间的差异无统计学意义。在4名接受表面活性剂治疗的婴儿中，呼吸窘迫的严重程度在出生后24至48小时之间恶化，这表明出生时一剂表面活性剂对某些婴儿可能不够。
Organic solvent extraction of surfactant obtained by lavage of calf lungs yields a highly surface-active material. A double blind, randomized clinical trial to determine the effect of this material on respiratory distress syndrome in premature infants was initiated in the Neonatal Intensive Care Unit at the University of Rochester in December 1983. Infants 25 to 29 weeks gestational age were eligible for entry into the trial. At the time of this interim analysis 32 patients had been randomly selected and entered into the trial, 16 surfactant-treated patients and 16 in a control group who received only saline. At birth, intrapulmonary instillation of the calf lung surfactant extract dispersed in saline or saline alone occurred in the delivery room immediately after intubation and prior to ventilation; infants were then ventilated and treated as usual. At 6, 12, 24, 48, and 72 hours after birth, the severity of respiratory distress was categorized as either minimal, intermediate, or severe based on oxygen and mean airway pressure requirements. Differences observed at six hours after birth were of marginal significance, but at 12 and 24 hours the surfactant-treated group had significantly (P less than .01) less severe respiratory distress compared with the control group. Differences between treated and control infants were not statistically significant at 48 and 72 hours after birth. In four surfactant-treated infants the severity of respiratory distress worsened between 24 and 48 hours after birth, suggesting that one dose of surfactant at birth may not be sufficient for some infants.