A multicenter, randomized, masked, comparison trial of lucinactant, colfosceril palmitate, and beractant for the prevention of respiratory distress syndrome among very preterm infants
A multicenter, randomized, masked, comparison trial of lucinactant, colfosceril palmitate, and beractant for the prevention of respiratory distress syndrome among very preterm infants
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DOI：
10.1542/peds.2004-2183
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发表时间：
2005-04-01
期刊：
影响因子：
8
通讯作者：
d'Agostino, R
中科院分区：
文献类型：
--
作者：
Moya, FR;Gadzinowski, J;d'Agostino, R
背景和目标。有证据表明，合成的表面活性剂组成的磷脂，可以通过添加肽，如辛纳屈肽，模仿人类表面活性蛋白-B（SP-B）的作用得到改善。含有SP-B模拟物的合成表面活性剂也可以降低与使用动物源性产品相关的潜在风险。我们的目的是比较含有功能性SP-B模拟物的新型合成表面活性剂的有效性和安全性（lucinactant; Discovery Laboratories，多尔斯敦，PA）与不含蛋白质的合成表面活性剂的那些混合（棕榈酸秋磷酯; GlaxoSmithKline，Brentford，United Kingdom）和牛源表面活性剂（beractant; Abbott Laboratories，Abbott Park，IL）在预防新生儿呼吸窘迫综合征（RDS）和RDS相关死亡中的作用。我们随机（双盲）分配了1294名体重600 - 1250 g的极早产儿，
Background and Objective. Evidence suggests that synthetic surfactants consisting solely of phospholipids can be improved through the addition of peptides, such as sinapultide, that mimic the action of human surfactant protein-B (SP-B). A synthetic surfactant containing a mimic of SP-B may also reduce the potential risks associated with the use of animal-derived products. Our objective was to compare the efficacy and safety of a novel synthetic surfactant containing a functional SP-B mimic (lucinactant; Discovery Laboratories, Doylestown, PA) with those of a non-protein-containing synthetic surfactant (colfosceril palmitate; GlaxoSmithKline, Brentford, United Kingdom) and a bovine-derived surfactant (beractant; Abbott Laboratories, Abbott Park, IL) in the prevention of neonatal respiratory distress syndrome (RDS) and RDS-related death.Methods. We assigned randomly (double-masked) 1294 very preterm infants, weighing 600 to 1250 g and of