Dunn M S, Shennan A T, Zayack D, Possmayer F
Regional Perinatal Unit, Women's College Hospital, Toronto, Ontario, Canada.
Pediatrics. 1991 Mar;87(3):377-86.
The influence of the timing of surfactant replacement therapy for the treatment of neonatal respiratory distress syndrome was evaluated in a study of 182 neonates of less than 30 weeks' gestation who were randomly assigned prior to delivery to one of three study groups: control (dummy instillation of air given at birth), early surfactant (surfactant given at birth), or late surfactant (surfactant given at less than 6 hours of age). Subjects in the late surfactant group could avoid treatment if they had a clear chest roentgenogram and required no supplemental oxygen at a mean airway pressure of less than 7 cm of water. All treated neonates were eligible to receive up to three additional doses during the first 5 days of life. The three groups were comparable with respect to birth weight, gestational age, and other perinatal parameters with the exception of a lower cord arterial pH and 1-minute Apgar score in the early surfactant group. Of the 60 neonates randomly assigned to late treatment, 29 (48%) were deemed surfactant sufficient and thereby avoided treatment; the other 31 received their first dose at a mean age of 2.9 hours. There was a significant improvement in gas exchange during the first week of life in both surfactant groups compared with the control group, reflected by differences in fraction of inspired oxygen, arterial/alveolar PO2, and ventilation index (peak pressure x rate on the ventilator) (P less than .001). Surfactant therapy also resulted in a lower incidence of pulmonary air leak and severe chronic lung disease (defined as requirement for respiratory support beyond 36 weeks post-conceptional age). There were no differences between early and late surfactant groups in any of these parameters. The only statistically significant difference between the surfactant groups was that the early group had a higher incidence of mild chronic lung disease (respiratory support beyond 28 days of age) than the late treatment group (P less than .005). Neonates in the late treatment group were extubated earlier and had a shorter neonatal intensive care unit stay than control neonates (P less than .05), whereas those in the early group were not significantly different from control neonates in these parameters. It is concluded that replacement therapy with bovine lung surfactant extract in neonates of less than 30 weeks' gestation results in decreased oxygen and ventilatory requirements during the first week of life and a lower incidence of pulmonary air leak and severe chronic lung disease.(ABSTRACT TRUNCATED AT 400 WORDS)
在一项针对182例孕周小于30周的新生儿的研究中，评估了表面活性剂替代疗法的治疗时机对新生儿呼吸窘迫综合征治疗的影响。这些新生儿在分娩前被随机分配到三个研究组之一：对照组（出生时给予空气假滴注）、早期表面活性剂组（出生时给予表面活性剂）或晚期表面活性剂组（出生后6小时内给予表面活性剂）。晚期表面活性剂组的受试者如果胸部X线片清晰且在平均气道压力小于7厘米水柱时不需要补充氧气，则可避免治疗。所有接受治疗的新生儿在出生后的前5天内有资格额外接受最多三剂治疗。除早期表面活性剂组的脐动脉pH值和1分钟阿氏评分较低外，三组在出生体重、孕周和其他围产期参数方面具有可比性。在随机分配到晚期治疗的60例新生儿中，29例（48%）被认为表面活性剂充足，从而避免了治疗；另外31例在平均年龄2.9小时时接受了第一剂治疗。与对照组相比，两个表面活性剂组在出生后第一周的气体交换均有显著改善，表现为吸入氧分数、动脉/肺泡氧分压和通气指数（呼吸机上的峰值压力×频率）的差异（P<0.001）。表面活性剂治疗还导致肺空气泄漏和严重慢性肺病（定义为孕龄36周后仍需要呼吸支持）的发生率降低。在这些参数中，早期和晚期表面活性剂组之间没有差异。表面活性剂组之间唯一具有统计学意义的差异是，早期组轻度慢性肺病（出生后28天以上仍需要呼吸支持）的发生率高于晚期治疗组（P<0.005）。晚期治疗组的新生儿拔管更早，新生儿重症监护病房住院时间比对照组新生儿短（P<0.05），而早期组在这些参数方面与对照组新生儿无显著差异。得出结论，孕周小于30周的新生儿使用牛肺表面活性剂提取物进行替代治疗可降低出生后第一周的氧气和通气需求，并降低肺空气泄漏和严重慢性肺病的发生率。（摘要截短至400字）
