Kattwinkel J, Bloom B T, Delmore P, Davis C L, Farrell E, Friss H, Jung A L, King K, Mueller D
Dept of Pediatrics, University of Virginia Health Science Center, Charlottesville, VA 22908.
Pediatrics. 1993 Jul;92(1):90-8.
Although numerous trials have demonstrated the efficacy of exogenous surfactant for prophylaxis or treatment of neonatal respiratory distress syndrome (RDS), optimum timing of administration remains controversial. One previous study showed that administration of calf lung surfactant extract immediately following birth, to neonates born before 30 weeks postconceptional age, was preferable to delaying administration until after development of RDS. The current study was designed to test a similar hypothesis for babies born between 29 and 32 weeks gestational age.
One thousand three hundred ninety-eight neonates with obstetric estimates of 29 through 32 weeks' gestation were randomized to receive CLSE at birth or to wait until development of mild RDS. After exclusions for malformations and other factors, data from 1248 were analyzed.
Prophylaxis was associated with less development of moderate RDS (7% vs 12%), less need for retreatment (5% vs 9%), less need for mechanical ventilation or supplemental oxygen during the first 4 days, and fewer deaths or less requirement for supplemental oxygen at 28 days (5% vs 9%). Although 1-minute Apgar scores were significantly lower in the prophylaxis group, the difference disappeared by the 5-minute score and there was no difference in the incidence of asphyxia-related complications. Sixty percent of the neonates assigned to early treatment received endotracheal intubation and 43% received calf lung surfactant extract at a median age of 1.5 hours. When data were analyzed by gestational age and birth weight subgroups, most of the differences could be attributable to babies born at 30 weeks or less or weighing less than 1500 g, probably because of the higher incidence of surfactant deficiency in this more immature subgroup.
尽管众多试验已证明外源性表面活性剂对预防或治疗新生儿呼吸窘迫综合征(RDS)有效,但最佳给药时机仍存在争议。此前一项研究表明,对于孕龄小于30周出生的新生儿,出生后立即给予小牛肺表面活性剂提取物比延迟至RDS发生后给药更为可取。本研究旨在针对孕龄在29至32周之间出生的婴儿验证类似假说。
1398例产科估计孕龄为29至32周的新生儿被随机分为两组,一组在出生时接受小牛肺表面活性剂提取物(CLSE),另一组等待至轻度RDS发生。在排除畸形和其他因素后,对1248例的数据进行了分析。
预防性给药组中、重度RDS的发生率较低(7%对12%),再次治疗的需求较少(5%对9%),出生后前4天对机械通气或补充氧气的需求较少,28天时死亡或补充氧气需求较少(5%对9%)。尽管预防性给药组1分钟阿氏评分显著较低,但5分钟评分时差异消失,且窒息相关并发症的发生率无差异。分配至早期治疗组的新生儿中有60%接受了气管插管,43%在中位年龄1.5小时时接受了小牛肺表面活性剂提取物。当按孕龄和出生体重亚组分析数据时,大多数差异可能归因于孕龄30周及以下或体重小于1500 g的婴儿,这可能是因为该更不成熟亚组中表面活性剂缺乏的发生率较高。