Department of Pediatrics, Boston University School of Medicine, Boston, MA 02118, USA.
J Perinatol. 2010 Oct;30(10):665-70. doi: 10.1038/jp.2010.20. Epub 2010 Mar 25.
Comparison of the differences between availability of animal-derived surfactant preparations used to treat premature infants is incomplete. The objective of this study was to assess the short-term treatment efficacy of the two most commonly used surfactant preparations in the United States, beractant (100 mg kg(-1) initial and subsequent doses) and poractant alfa (200 mg kg(-1) initial and 100 mg kg(-1) subsequent doses), in very premature, mechanically ventilated infants <30 weeks gestation with respiratory distress syndrome (RDS).
Inborn infants at two institutions, open label, 1:1, randomized controlled trial. Level of respiratory support for first 72 h of life. Morbidities of prematurity observed during the neonatal intensive care unit hospitalization.
We studied 52 infants 24 0/7 to 29 6/7 weeks gestation; 25 received poractant alfa (27.1±1.6 weeks, birth weight of 930±231 g) and 27 received beractant (26.7±1.7 weeks, P=0.343 and birth weight 900±271 g, P=0.668). Respiratory support for the first 72 h of life was lower in the poractant alfa than beractant group for mean airway pressure (MAP, P=0.003) and respiratory index (MAP × FiO(2), P=0.032). Infants in the poractant alfa group had a greater number of infants extubated at 48 (13/25 vs 6/27, P=0.027) and 72 h (15/25 vs 8/27, P=0.029) than the beractant group. Although the study was not powered to detect morbidities of prematurity, the prevalence of PDA and air leaks was less in the infants treated with poractant alfa than in those treated with beractant. Rates of bronchopulmonary dysplasia (8/23 vs 11/22, P=0.303) or death (2/25 [corrected] vs 5/27, P=0.272) were similar in the infants treated with poractant alfa and beractant, respectively.
This study suggests significant short-term benefits to the use of the larger initial dose of poractant alfa than beractant in very premature infants with RDS. Further studies involving a larger number of preterm infants are needed to assess long-term effects.
比较用于治疗早产儿的动物来源表面活性剂制剂的可获得性差异不完整。本研究的目的是评估美国最常用的两种表面活性剂制剂——猪肺磷脂（100mg/kg 初始剂量和随后的剂量）和牛肺表面活性剂（200mg/kg 初始剂量和 100mg/kg 随后剂量）在胎龄<30 周、有呼吸窘迫综合征（RDS）的机械通气的极早产儿中的短期治疗效果。
在两个机构中，采用开放性标签、1:1、随机对照试验。研究出生后 72 小时内的呼吸支持水平。观察新生儿重症监护病房住院期间早产儿的并发症。
我们研究了 52 名胎龄 24 0/7 至 29 6/7 周的婴儿；25 名婴儿接受了牛肺表面活性剂（27.1±1.6 周，出生体重 930±231g），27 名婴儿接受了猪肺磷脂（26.7±1.7 周，P=0.343，出生体重 900±271g，P=0.668）。在第一个 72 小时的生命中，猪肺磷脂组的平均气道压力（MAP，P=0.003）和呼吸指数（MAP×FiO2，P=0.032）均低于牛肺表面活性剂组。牛肺表面活性剂组中，有更多的婴儿在 48 小时（13/25 比 6/27，P=0.027）和 72 小时（15/25 比 8/27，P=0.029）时拔管，而猪肺磷脂组的婴儿则更少。尽管该研究没有足够的统计学效力来检测早产儿的并发症，但接受牛肺表面活性剂治疗的婴儿的 PDA 和空气泄漏的发生率低于接受猪肺磷脂治疗的婴儿。接受牛肺表面活性剂和猪肺磷脂治疗的婴儿的支气管肺发育不良发生率（8/23 比 11/22，P=0.303）或死亡率（2/25 比 5/27，P=0.272）相似。
本研究表明，在有 RDS 的极早产儿中，使用较大初始剂量的牛肺表面活性剂比猪肺磷脂有显著的短期益处。需要进一步进行涉及更多早产儿的研究来评估长期影响。
