一年随访的早产儿接受lucinactant呼吸窘迫综合征的预防:结果从2多中心的随机对照试验。
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莫亚F, Sinha年代,Gadzinowski J R,达西格尔R,‘C,刘Mazela J, G
一年随访的早产儿接受lucinactant呼吸窘迫综合征的预防:结果从2多中心的随机对照试验。
儿科。2007年6月,119 (6):e1361 - 70。2007年5月28日Epub。
- PubMed ID
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17533176 (在PubMed]
- 文摘
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背景:外源性表面活性剂的好处对于预防或治疗呼吸窘迫综合征已经很成熟,但缺乏长期随访surfactant-comparison试验的数据。目的:我们试图确定和比较生存和肺和神经发育的结果在1年岁纠正早产儿接受lucinactant和其他表面活性剂的选择(lucinactant与Exosurf的安全性和有效性的临床试验)和明星(Surfaxin疗法对呼吸窘迫综合征)试验分别,其次,从使用组合这两个试验的数据分析。来自两种试验方法:所有婴儿被随机分配到lucinactant管理局(175毫克/公斤),colfosceril棕榈酸酯(67.5毫克/公斤),beractant(100毫克/公斤),或poractant阿尔法(175毫克/公斤)通过1年前瞻性跟踪纠正年龄,这时蒙面的评估结果进行了幸存的婴儿。为期一年的生存是一个重要的结果。其他参数评估包括利率再入院治疗和呼吸道发病率和严重神经功能状态。数据分析通过比较不同的表面活性剂在每一个试验,在二级分析,结合两种试验的数据比较lucinactant与动物表面活性剂(beractant和poractant)用于这些试验。存活率随着时间的比较通过使用Wilcoxon测试为生存1年校正年龄和逻辑回归的比较固定的时间点。后者分析通过使用指定的方法,追踪损失或撤回同意估算是死亡,并使用原始数据。其他结果分析利用Cochran-Mantel-Haenszel测试或逻辑回归对分类数据,排名和方差分析是用于连续数据。结果:很少例失访的审判(29 1546参加试验[1.9%])。 In the primary analysis of the SELECT trial comparing lucinactant to either colfosceril or beractant, there were no significant differences in the proportion of infants who were alive through 1 year corrected age. Fixed-time-point estimates of mortality at 1 year corrected age imputing loss to follow-up as a death were 28.1% for lucinactant, 31.0% for colfosceril, and 31.0% for beractant. By using raw data without imputing loss to follow-up as a death, mortality estimates at 1 year corrected age were computed to be 26.6%, 29.1%, and 28.3%, respectively. In the primary analysis of the STAR trial, significantly more infants treated with lucinactant were alive through 1 year corrected age compared with those who received poractant alfa. Fixed time estimates of mortality at 1 year corrected age imputing loss to follow-up as a death were 19.4% for lucinactant and 24.2% for poractant. These estimates using raw data that did not impute loss to follow-up as a death were 18.6% and 21.9%, respectively. In the combined analysis, survival through 1 year corrected age was higher for infants in the lucinactant group versus that of the infants in the animal-derived surfactants (beractant and poractant) group. The fixed-time-point estimates of mortality at 1 year corrected age imputing loss to follow-up as a death for lucinactant and animal-derived surfactants were 26.0% and 29.4%, respectively. However, the 1-year-corrected-age estimates using combined raw data were 24.6% for the lucinactant group and 26.7% for the animal-derived surfactant group. The incidence of postdischarge rehospitalizations, total number of rehospitalizations, incidence of respiratory illnesses, and total number of respiratory illnesses were generally similar among those in the treatment groups. Neurologic status at 1 year corrected age was essentially similar between infants who received lucinactant and those who received all other surfactants used in these 2 trials. CONCLUSIONS: Findings from this 1-year follow-up of both lucinactant trials indicate that this new peptide-based synthetic surfactant is at least as good, if not superior, to animal-derived surfactants for prevention of respiratory distress syndrome and may be a viable alternative to animal-derived products.
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