Kendig J W, Notter R H, Cox C, Reubens L J, Davis J M, Maniscalco W M, Sinkin R A, Bartoletti A, Dweck H S, Horgan M J
Department of Pediatrics (Neonatology), University of Rochester School of Medicine, NY 14642.
N Engl J Med. 1991 Mar 28;324(13):865-71. doi: 10.1056/NEJM199103283241301.
Exogenous pulmonary surfactants are administered into the trachea either to prevent respiratory distress syndrome in premature infants or to treat it. In a randomized, multicenter trial, we compared the results of surfactant therapy initiated as prophylaxis with the results of rescue therapy with surfactant.
Before birth, 479 infants with an estimated gestational age of less than 30 weeks were randomly assigned to receive surfactant as prophylaxis (n = 235) or rescue therapy (n = 244). The infants in the prophylaxis group received a 90-mg intratracheal dose of an exogenous calf-lung surfactant extract at the time of delivery, whereas the infants in the rescue-therapy group received 90 mg of the surfactant several hours after delivery if the fractional inspiratory oxygen concentration was at least 0.40 or if the mean airway pressure was at least 0.686 kPa (7 cm of water), or both. Infants in both groups received additional doses of surfactant at intervals of 12 to 24 hours if these criteria were met.
The proportion of infants surviving until discharge to their homes was significantly higher in the prophylaxis group than in the rescue-therapy group (88 vs. 80 percent, P = 0.028). This difference was due primarily to the longer survival of very premature infants (less than or equal to 26 weeks' gestation) in the prophylaxis group than in the rescue-therapy group (75 vs. 54 percent, P = 0.006). According to proportional-hazards regression analysis, the distribution of survival times was better for all infants in the prophylaxis group (P = 0.007) and for the subgroup of infants in the prophylaxis group who were delivered at 26 weeks' gestation or earlier (P = 0.0048). Infants in the prophylaxis group who were delivered at 26 weeks' gestation or earlier had a lower incidence of pneumothorax than similar infants in the rescue-therapy group (7 vs. 18 percent, P = 0.03).
We found a significant advantage to the administration of the initial dose of surfactant as prophylaxis rather than as rescue therapy in very premature infants.
外源性肺表面活性物质经气管给药，用于预防或治疗早产儿呼吸窘迫综合征。在一项随机、多中心试验中，我们比较了预防性使用表面活性物质治疗的结果与使用表面活性物质进行挽救性治疗的结果。
在出生前，将479名估计孕周小于30周的婴儿随机分为两组，分别接受预防性表面活性物质治疗（n = 235）或挽救性治疗（n = 244）。预防性治疗组的婴儿在分娩时接受90毫克气管内注射的外源性小牛肺表面活性物质提取物，而挽救性治疗组的婴儿在分娩后数小时，当吸入氧分数浓度至少为0.40或平均气道压至少为0.686千帕（7厘米水柱），或两者均满足时，接受90毫克表面活性物质治疗。如果满足这些标准，两组婴儿每隔12至24小时接受额外剂量的表面活性物质治疗。
预防性治疗组婴儿存活至出院回家的比例显著高于挽救性治疗组（88%对80%，P = 0.028）。这种差异主要是由于极早产儿（孕周小于或等于26周）在预防性治疗组中的存活时间长于挽救性治疗组（75%对54%，P = 0.006）。根据比例风险回归分析，预防性治疗组所有婴儿的生存时间分布更好（P = 0.007），对于孕周为26周或更早分娩的预防性治疗组婴儿亚组也是如此（P = 0.0048）。孕周为26周或更早分娩的预防性治疗组婴儿气胸发生率低于挽救性治疗组中的类似婴儿（7%对18%，P = 0.03）。
我们发现，对于极早产儿，预防性给予初始剂量的表面活性物质而非进行挽救性治疗具有显著优势。
