Pediatrics. 1996 Jan;97(1):1-6.
To compare the efficacy of a synthetic surfactant (Exosurf Neonatal, Burroughs-Wellcome Co) and a modified bovine surfactant extract (Survanta, Ross Laboratories) in the treatment of neonatal respiratory distress syndrome (RDS).
Multicenter, randomized trial.
Thirty-eight neonatal intensive care units participating in the Vermont-Oxford Neonatal Network.
Premature infants (n = 1296) weighing 501 to 1500 g with RDS requiring assisted ventilation with 30% oxygen or more were enrolled within 6 hours of birth.
Infants were randomly assigned to receive up to four intratracheal doses of the synthetic surfactant (Exosurf Neonatal, n = 644) or the modified bovine surfactant extract (Survanta, n = 652).
The primary outcome measure was the occurrence of death or chronic lung disease 28 days after birth.
Death or chronic lung disease occurred in 57% of the infants treated with Exosurf Neonatal and in 54% of those infants treated with Survanta (relative risk [RR], 0.95; 95% confidence interval [CI], 0.86 to 1.04). Infants with birth weights of 1001 to 1500 g who received Survanta had a significantly lower risk of chronic lung disease or death at 28 days (Survanta, 27% vs Exosurf, 34%; RR, 0.78; 95% CI, 0.60 to 0.99). Treatment with Survanta led to significant improvement in several secondary outcome measures. Survanta-treated infants received less supplemental oxygen and had lower mean airway pressure 6 and 72 hours after treatment. Survanta-treated infants had significantly fewer pneumothoraces (Survanta, 9% vs Exosurf, 15%; RR, 0.60; 95% CI, 0.44 to 0.81). There were no differences between the groups in the incidence of other neonatal complications.
Although no differences were noted between Survanta- and Exosurf-treated infants regarding the primary outcome of death or chronic lung disease at 28 days of age, the significant improvement in secondary clinical outcomes suggests that Survanta is more effective than Exosurf Neonatal in the treatment of established RDS.
比较合成表面活性剂（固尔苏，百时美施贵宝公司）和改良牛肺表面活性剂提取物（珂立苏，罗斯实验室）治疗新生儿呼吸窘迫综合征（RDS）的疗效。
多中心随机试验。
38个参与佛蒙特-牛津新生儿网络的新生儿重症监护病房。
出生体重501至1500克、患有RDS且需要30%或更高浓度氧气辅助通气的早产儿（n = 1296）在出生后6小时内入组。
婴儿被随机分配接受最多4次气管内剂量的合成表面活性剂（固尔苏，n = 644）或改良牛肺表面活性剂提取物（珂立苏，n = 652）。
主要观察指标为出生后28天死亡或慢性肺病的发生情况。
接受固尔苏治疗的婴儿中有57%发生死亡或慢性肺病，接受珂立苏治疗的婴儿中有54%发生死亡或慢性肺病（相对危险度[RR]，0.95；95%可信区间[CI]，0.86至1.04）。出生体重1001至1500克且接受珂立苏治疗的婴儿在28天时患慢性肺病或死亡的风险显著较低（珂立苏组为27%，固尔苏组为34%；RR，0.78；95%CI，0.60至0.99）。珂立苏治疗使多项次要观察指标有显著改善。接受珂立苏治疗的婴儿补充氧气较少，治疗后6小时和72小时平均气道压力较低。接受珂立苏治疗的婴儿气胸明显较少（珂立苏组为9%，固尔苏组为15%；RR，0.60；95%CI，0.44至0.81）。两组在其他新生儿并发症发生率方面无差异。
虽然在28日龄时，接受珂立苏和固尔苏治疗的婴儿在死亡或慢性肺病这一主要观察指标上未发现差异，但次要临床指标的显著改善表明，在治疗已确诊的RDS方面，珂立苏比固尔苏更有效。
