Hudak M L, Farrell E E, Rosenberg A A, Jung A L, Auten R L, Durand D J, Horgan M J, Buckwald S, Belcastro M R, Donohue P K, Carrion V, Maniscalco W W, Balsan M J, Torres B A, Miller R R, Jansen R D, Graeber J E, Laskay K M, Matteson E J, Egan E A, Brody A S, Martin D J, Riddlesberger M M, Montgomery P
Department of Pediatrics, Children's Hospital of Buffalo, State University of New York, USA.
J Pediatr. 1996 Mar;128(3):396-406. doi: 10.1016/s0022-3476(96)70291-3.
To compare the efficacy and safety of two surfactant preparations in the treatment of respiratory distress syndrome (RDS).
We conducted a randomized, masked comparison trial at 21 centers. Infants with RDS who were undergoing mechanical ventilation were eligible for treatment with two doses of either a synthetic (Exosurf) or natural (Infasurf) surfactant if the ratio of arterial to alveolar partial pressure of oxygen was less than or equal to 0.22. Crossover treatment was allowed within 96 hours of age if severe respiratory failure (defined as two consecutive arterial/alveolar oxygen tension ratios < or = 0.10) persisted after two doses of the randomly assigned surfactant. Four primary outcome measures of efficacy (the incidence of pulmonary air leak (< or = 7 days); the severity of RDS; the incidence of death from RDS; and the incidence of survival without bronchopulmonary dysplasia (BPD) at 28 days after birth) were compared by means of linear regression techniques.
The primary analysis of efficacy was performed in 1033 eligible infants and an analysis of safety outcomes in the 1126 infants who received study surfactant. Preentry demographic characteristics and respiratory status were similar for the two treatment groups, except for a small but significant difference in mean gestational age (0.5 week) that favored the infasurf treatment group. Pulmonary air leak (< or = 7 days) occurred in 21% of Exosurf- and 11% of infasurf-treated infants (adjusted relative risk, 0.53; 95% confidence interval, 0.40 to 0.71; p < or = 0.0001). During the 72 hours after the initial surfactant treatment, the average fraction of inspired oxygen (+/-SEM) was 0.47 +/- 0.01 for Exosurf- and 0.39 +/- 0.01 for infasurf-treated infants (difference, 0.08; 95% confidence interval, 0.06 to 0.10; p < 0.0001); the average mean airway pressure (+/-SEM) was 8.6 +/- 0.1 cm H2O; for Exosurf- and 7.2 +/- 0.1 cm H2O for Infasurf-treated infants (difference, 1.4 cm H2O; 95% confidence interval, 1.0 to 1.8 cm H2O; p < 0.0001). The incidences of RDS-related death, total respiratory death, death to discharge, and survival without bronchopulmonary dysplasia at 28 days after birth did not differ. The number of days of more than 30% inspired oxygen and of assisted ventilation, but not the duration of hospitalization, were significantly lower in Infasurf-treated infants.
Compared with Exosurf, Infasurf provided more effective therapy for RDS as assessed by significant reductions in the severity of respiratory disease and in the incidence of air leak complications.
比较两种表面活性剂制剂治疗呼吸窘迫综合征（RDS）的疗效和安全性。
我们在21个中心进行了一项随机、盲法对照试验。患有RDS且正在接受机械通气的婴儿，如果动脉血氧分压与肺泡血氧分压之比小于或等于0.22，则有资格接受两剂合成表面活性剂（Exosurf）或天然表面活性剂（Infasurf）治疗。如果在给予两剂随机分配的表面活性剂后仍存在严重呼吸衰竭（定义为连续两个动脉/肺泡氧分压比<或=0.10），则允许在96小时龄内进行交叉治疗。通过线性回归技术比较了四项主要疗效指标（肺漏气发生率（<或=7天）；RDS严重程度；RDS死亡发生率；出生后28天无支气管肺发育不良（BPD）存活的发生率）。
对1033名符合条件的婴儿进行了疗效的初步分析，并对接受研究表面活性剂的1126名婴儿进行了安全性结果分析。两个治疗组的入院前人口统计学特征和呼吸状况相似，但平均胎龄存在微小但显著的差异（0.5周），Infasurf治疗组更具优势。接受Exosurf治疗的婴儿中有21%发生肺漏气（<或=7天），接受Infasurf治疗的婴儿中有11%发生肺漏气（调整后的相对风险为0.53；95%置信区间为0.40至0.71；p<或=0.0001）。在初始表面活性剂治疗后的72小时内，接受Exosurf治疗的婴儿吸入氧分数（+/-SEM）平均为0.47+/-0.01，接受Infasurf治疗的婴儿为0.39+/-0.01（差异为0.08；95%置信区间为0.06至0.10；p<0.0001）；平均气道压（+/-SEM）在接受Exosurf治疗的婴儿中为8.6+/-0.1 cm H2O，在接受Infasurf治疗的婴儿中为7.2+/-0.1 cm H2O（差异为1.4 cm H2O；95%置信区间为1.0至1.8 cm H2O；p<0.0001）。出生后28天，RDS相关死亡、总呼吸死亡、出院时死亡以及无支气管肺发育不良存活的发生率没有差异。接受Infasurf治疗的婴儿吸入氧超过30%的天数和辅助通气天数显著减少，但住院时间没有差异。
与Exosurf相比，Infasurf对RDS的治疗更有效，这体现在呼吸疾病严重程度和漏气并发症发生率的显著降低。
