Horbar J D, Wright E C, Onstad L
Dept of Pediatrics, University of Vermont College of Medicine, Burlington 05405.
Pediatrics. 1993 Aug;92(2):191-6.
To determine whether the introduction of surfactant therapy was associated with decreased mortality for high-risk preterm neonates weighing 601 to 1300 g at birth.
Before-after observational study.
Eight tertiary care neonatal intensive care units participating in the National Institute of Child Health and Human Development Neonatal Research Network.
The outcomes for neonates with birth weight 601 to 1300 g admitted in the 2 years before surfactants became available (n = 2780) were compared with those of neonates admitted in the year beginning 2 months after surfactants became available (n = 1413).
The primary outcome measure was in-hospital mortality; secondary outcome measures included durations of assisted ventilation, length of hospitalization, and neonatal morbidity.
Forty percent of neonates in the postsurfactant group received surfactant (range 28% to 69% at the centers). Mortality decreased from 27.8% before to 19.9% after surfactant therapy was introduced (Mantel-Haenszel chi 2 = 31.4, P = .001). The adjusted odds ratio for mortality after surfactants became available was 0.73 (95% confidence interval 0.55 to 0.95). The duration of assisted ventilation and length of hospitalization increased after surfactants were introduced (P = .0001 for both outcomes).
Mortality for neonates weighing 601 to 1300 g decreased after surfactant therapy was introduced, suggesting that the efficacy of surfactants demonstrated in randomized controlled trials will translate into effectiveness in routine clinical care.
确定表面活性剂疗法的引入是否与出生体重601至1300克的高危早产儿死亡率降低相关。
前后观察性研究。
八个参与美国国立儿童健康与人类发展研究所新生儿研究网络的三级医疗新生儿重症监护病房。
将表面活性剂可用前2年入院的出生体重601至1300克的新生儿(n = 2780)的结局与表面活性剂可用后2个月开始的那一年入院的新生儿(n = 1413)的结局进行比较。
主要结局指标是住院死亡率;次要结局指标包括辅助通气时间、住院时间和新生儿发病率。
表面活性剂治疗组中40%的新生儿接受了表面活性剂治疗(各中心范围为28%至69%)。引入表面活性剂疗法后,死亡率从之前的27.8%降至19.9%(Mantel-Haenszel卡方检验= 31.4,P = .001)。表面活性剂可用后死亡率的调整优势比为0.73(95%置信区间0.55至0.95)。引入表面活性剂后,辅助通气时间和住院时间增加(两个结局的P值均为.0001)。
引入表面活性剂疗法后,出生体重601至1300克的新生儿死亡率降低,这表明随机对照试验中证明的表面活性剂疗效将转化为常规临床护理中的有效性。