A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome
A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome
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DOI：
10.1016/s0022-3476(96)70291-3
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发表时间：
1996-03-01
影响因子：
5.1
通讯作者：
Montgomery, P
中科院分区：
文献类型：
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作者：
Hudak, ML;Farrell, EE;Montgomery, P
目的：比较两种表面活性剂制剂的有效性和安全性。方法：我们在21个中心进行了一项随机、盲法比较试验。如果动脉与肺泡氧分压的比值小于或等于0.22，则接受机械通气的RDS婴儿有资格接受两种剂量的合成（Exosurf）或天然（Infasurf）表面活性剂治疗。如果出现严重呼吸衰竭，允许在96小时内交叉治疗（定义为连续两次动脉/肺泡氧分压比小于或等于0.10）在两次随机分配的表面活性剂给药后持续存在，（肺漏气发生率（≤ 7天）、RDS严重程度、RDS死亡率;和生后28天无支气管肺发育不良（BPD）的生存率）进行线性回归分析。在1033名合格婴儿中进行了疗效的主要分析，并在1126名接受研究表面活性剂的婴儿中进行了安全性结局分析，两个治疗组的入组前人口统计学特征和呼吸状态相似，但平均胎龄（0.5周）存在较小但显著的差异，有利于Infasurf治疗组。肺漏气Exosurf治疗组和Infasurf治疗组中分别有21%和11%的婴儿发生（小于或等于7天）（校正相对危险度，0.53; 95%置信区间，0.40 - 0.71; p小于或等于0.0001），在初始表面活性剂处理后的72小时期间，Exosurf治疗组和Infasurf治疗组婴儿的平均吸入氧分数（+/- SEM）分别为0.47 +/- 0.01和0.39 +/- 0.01（差异，0.08; 95%置信区间，0.06至0.10; p < 0.0001）; Exosurf治疗婴儿的平均气道压（+/- SEM）为8.6 +/- 0.1 cm H2O，Infasurf治疗婴儿为7.2 +/- 0.1 cm H2O（差异，1.4 cm H2O; 95%置信区间，1.0至1.8 cm H2O; p < 0.0001）。RDS相关死亡、总呼吸道死亡、出院前死亡和出生后28天无支气管肺发育不良的存活率无差异。天数超过30%的吸入氧气和辅助通气，但不住院的持续时间，显着降低Infasurf治疗infants.Conclusion：与Exosurf相比，Infasurf提供了更有效的治疗RDS评估的呼吸系统疾病的严重程度和漏气并发症的发生率显着降低。
Objective: To compare the efficacy and safety of two surfactant preparations iMethods: 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 less than or equal to 0.10) persisted after two doses of the randomly assigned surfactant, Four primary outcome measures of efficacy (the incidence of pulmonary air leak (less than or equal to 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.Results: 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 fdr 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 (less than or equal to 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 less than or equal to 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 H-2o; 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.Conclusion: 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.