Bevilacqua G, Parmigiani S, Robertson B
Institute of Child Health and Neonatal Medicine, University of Parma, Italy.
J Perinat Med. 1996;24(6):609-20. doi: 10.1515/jpme.1996.24.6.609.
The objective of this prospective, multicentre trial, carried out at 18 third level hospitals in Italy, was to evaluate efficacy of modified porcine surfactant (Curosurf), administered at birth to prevent the development of respiratory distress syndrome (RDS) in premature infants. 287 babies with a gestational age of 24-30 weeks were randomized to prophylactic treatment with Curosurf (80 mg/ml; dose 20 mg/kg) or to a control group receiving no surfactant treatment in the delivery-room. Babies in both groups were eligible for rescue treatment with surfactant (200 mg/kg) if they developed clinical symptoms of RDS and required mechanical ventilation. The main end-point was to obtain, in the prophylaxis group, a 30% reduction in the incidence of grade 3-4 RDS. Median gestational age was 28 weeks in both groups and mean birth weight 1010 and 1002 g, respectively for prophylaxis and control babies. There was a 32% reduction in the incidence of grade 3-4 RDS in the prophylaxis group (p < 0.05). This was associated with a significant reduction in mean maximum fraction of inspired oxygen (0.57 vs 0.66%; p < 0.01), a decreased incidence of pulmonary interstitial emphysema (7 vs 14%; p < 0.05) and a lowered mortality (21 vs 35%; p < 0.01). Combined unfavourable outcome (mortality + bronchopulmonary dysplasia and/or grade 3-4 intraventricular hemorrhage and/or grade 2-4 retinopathy of prematurity) was significantly lower in the prophylaxis than in the second group (41 vs 58%; p < 0.01). The favourable effects of prophylactic treatment were equally recorded in all the age groups, including the babies with the lowest gestational age (24-25 weeks). Multiple and logistic regression analysis confirmed that high gestational age and surfactant prophylaxis were, independently, associated with a lower degree of RDS (p = 0.0001 and p = 0.0008, respectively) and a lower mortality (p = 0.0001 and p = 0.0045, respectively). We conclude that prophylaxis with modified natural surfactant effectively prevents RDS in newborn babies between 24 and 30 weeks' gestation.
这项前瞻性多中心试验在意大利的18家三级医院开展，目的是评估出生时给予改良猪肺表面活性物质（珂立苏）预防早产儿呼吸窘迫综合征（RDS）的疗效。287名孕周为24 - 30周的婴儿被随机分为两组，一组接受珂立苏预防性治疗（80 mg/ml；剂量20 mg/kg），另一组为对照组，在产房不接受表面活性物质治疗。两组婴儿若出现RDS临床症状并需要机械通气，均有资格接受挽救性表面活性物质治疗（200 mg/kg）。主要终点是在预防组中使3 - 4级RDS的发生率降低30%。两组的中位孕周均为28周，预防组和对照组婴儿的平均出生体重分别为1010 g和1002 g。预防组3 - 4级RDS的发生率降低了32%（p < 0.05）。这与平均最大吸入氧分数显著降低相关（0.57%对0.66%；p < 0.01），肺间质气肿的发生率降低（7%对14%；p < 0.05），死亡率降低（21%对35%；p < 0.01）。预防组的联合不良结局（死亡率 + 支气管肺发育不良和/或3 - 4级脑室内出血和/或2 - 4级早产儿视网膜病变）显著低于第二组（41%对58%；p < 0.01）。预防性治疗的有益效果在所有年龄组中均有记录，包括孕周最小的婴儿（24 - 25周）。多元和逻辑回归分析证实，高孕周和表面活性物质预防分别独立地与较低程度的RDS（p分别为0.0001和0.0008）以及较低的死亡率（p分别为0.0001和0.0045）相关。我们得出结论，用改良天然表面活性物质进行预防可有效预防孕周在24至30周的新生儿患RDS。
