Bovine surfactant replacement therapy in neonates of less than 30 weeks' gestation: a randomized controlled trial of prophylaxis versus treatment.
Bovine surfactant replacement therapy in neonates of less than 30 weeks' gestation: a randomized controlled trial of prophylaxis versus treatment.
复制标题
妊娠 30 周以下新生儿的牛表面活性剂替代疗法：预防与治疗的随机对照试验。
DOI：
10.1542/peds.87.3.377
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发表时间：
1991
期刊：
影响因子：
8
通讯作者：
F. Possmayer
中科院分区：
文献类型：
--
作者：
Michael S. Dunn;Andrew T. Shennan;Denise Zayack;F. Possmayer
在一项对182名孕龄小于30周的新生儿进行的研究中，评价了表面活性物质替代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：控制（出生时给予空气的模拟滴注）、早期表面活性剂（出生时给予表面活性剂）或晚期表面活性剂（小于6小时龄时给予表面活性剂）。晚期表面活性物质组的受试者如果胸部X线片清晰，并且在平均气道压低于7 cm水柱时不需要补充氧气，则可以避免治疗。所有接受治疗的新生儿在出生后的前5天内都有资格接受最多3次额外剂量。除了早期表面活性物质组的脐带动脉pH值较低和1分钟Apgar评分外，三组在出生体重、胎龄和其他围产期参数方面具有可比性。在随机分配至晚期治疗的60例新生儿中，29例（48%）被认为表面活性剂充足，因此避免了治疗;其他31例在平均年龄2.9小时时接受首次给药。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有显著改善，这反映在吸入氧分数、动脉/肺泡PO 2和通气指数（呼吸机上的峰值压力x速率）的差异上（P <0.001）。表面活性剂治疗还导致肺漏气和严重慢性肺病（定义为受孕后36周以上需要呼吸支持）的发生率降低。早期和晚期表面活性剂组在任何这些参数中没有差异。表面活性剂组之间唯一的统计学显著差异是早期组的轻度慢性肺病（28天以上的呼吸支持）发生率高于晚期治疗组（P <0.005）。晚期治疗组的新生儿拔管时间较早，新生儿重症监护室停留时间较短（P <0.05），而早期治疗组的新生儿在这些参数方面与对照组新生儿无显著差异。它的结论是，补充治疗与牛肺表面活性物质提取物在小于30周的妊娠新生儿的结果，在生命的第一周内减少氧气和呼吸的需求和较低的发生率肺漏气和严重的慢性肺部疾病。（400字处截断摘要）
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)