Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25-29 weeks' gestation: a randomised trial
Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25-29 weeks' gestation: a randomised trial
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DOI：
10.1016/s0140-6736(00)02136-x
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发表时间：
2000-04-22
期刊：
影响因子：
168.9
通讯作者：
Platt, MPW
中科院分区：
文献类型：
--
作者：
Ainsworth, SB;Beresford, MW;Platt, MPW
背景外源性表面活性剂制剂的组成和生物物理性质各不相同。与对照组相比，合成和动物源性制剂降低了死亡率。在随机试验中，它们之间的死亡率或重要的长期临床结局没有显着差异。我们进行了一项随机对照试验，比较了合成表面活性剂普马可坦与动物源性表面活性剂poractant alfa，方法我们招募了212名出生于孕25周至29周、孕6天的新生儿，我们将105名新生儿随机分配为阿伐他汀组和107名普伐他汀组。主要结局是高度依赖性护理的持续时间，死亡率是次要结局。分析的意图treat.Findings结果数据进行了分析，为199名婴儿。根据数据和安全性监测委员会的建议，试验停止，因为死亡率比主要结局更重要，两组之间的出院前死亡率差异显著，有利于poractant alfa（14.1 vs 31.0%，p=0.006;比值比0.37 [95% CI 0.18-0.76）。在校正了研究中心、妊娠期、出生体重、性别、多胎和产前类固醇使用情况后，这种差异仍然存在。解释：接受poractant alfa治疗的新生儿的死亡率出乎意料地低于接受pumactant治疗的新生儿，并且与我们研究的所有变量无关。提前停止试验可能扩大了治疗组之间的差异。
Background Exogenous surfactant preparations vary in their constitution and biophysical properties. Synthetic and animal-derived preparations lower the rate of death compared with controls. No significant differences in mortality or important long-term clinical outcomes have been shown between them in randomised trials, We did a randomised controlled trial to compare pumactant, a synthetic surfactant, with poractant alfa, an animal-derived surfactant, both of which are widely used in the UK.Methods We enrolled 212 neonates born between 25 weeks' and 29 weeks and 6 days' gestation who were intubated for presumed surfactant deficiency and were free from life-threatening malformations, We randomly assigned 105 neonates poractant alfa, and 107 pumactant. The primary outcome was duration of high-dependency care and mortality was a secondary outcome. Analysis was by intention to treat.Findings Outcome data were analysed for 199 babies. The trial was stopped on the recommendation of the data and safety monitoring committee because mortality assumed a greater importance than the primary outcome, Predischarge mortality differed significantly between groups, in favour of poractant alfa (14.1 vs 31.0%, p=0.006; odds ratio 0.37 [95% CI 0.18-0.76). This difference was sustained after adjustment for centre, gestation, birthweight, sex, plurality, and use of antenatal steroids,Interpretation Mortality was unexpectedly lower among neonates who received poractant alfa than among those who received pumactant, and was independent of all the variables we investigated. Stopping the trial early may have widened the difference between the treatment groups.