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表面活性剂用于预防自主呼吸的新生儿呼吸窘迫综合征。一项随机多中心临床试点研究。

Use of surfactant for prevention of respiratory distress syndrome in newborn infants in spontaneous breathing. A randomized multicentre clinical pilot-study.

作者信息

Dambeanu J M, Parmigiani S, Marinescu B, Bevilacqua G

机构信息

Department of Obstetrics, P. Sârbu Hospital, Bucharest, Romania.

出版信息

Acta Biomed Ateneo Parmense. 1997;68 Suppl 1:39-45.

PMID:10021716
Abstract

OBJECTIVE

To evaluate the impact of administration of surfactant to premature infants in the delivery-room on respiratory distress syndrome (RDS) and short-term (28 days) mortality and outcome in a developing country where mechanical ventilators for infants were not available at the time of the study and neonatal mortality rate is extremely high.

DESIGN

Babies with gestational age 28-33 wks were randomly assigned to receive porcine surfactant prophylaxis (200 mg/kg endotracheally) in the delivery-room or routine assistance in 4 hospitals in Romania. After randomization, supplemental oxygen and continuous airway positive pressure were allowed if available. No rescue treatment was allowed. Diagnosis of RDS was done by means of Silverman score > or = 3 within 24 hrs + requirement of supplemental oxygen > or = 40%. Other examinations were performed depending on local availability.

RESULTS

53 babies were analyzed, and 28 were given prophylaxis while 25 resulted controls. The two groups did not differ for gestational age and birth weight (mean values for prophylaxis and control infants respectively: 30.6 +/- 1.6 vs 30.2 +/- 1.7 wks and 1457 +/- 258 vs 1397 +/- 388 g.), nor for sex, type of delivery and Apgar score. Mortality 0-28 days was 42.8 vs 48% in the prophylaxis vs control group (p = ns), due prevalently to intracerebral haemorrhage in both groups. Babies given surfactant tended to die later than controls. The Silverman score resulted significantly reduced in the first 24 hours in the babies given prophylaxis vs the controls (p < 0.05) and values of PaO2/FiO2 ratio were almost constantly higher in the babies that received surfactant compared to the control infants during the first three days of life, even if the differences were not significant.

CONCLUSION

Our data confirm that prophylaxis of RDS with surfactant in the delivery-room is able to improve the clinical conditions of the babies, however without the complete support of neonatal intensive care it does not resolve the problem of survival and unfavourable outcome in the babies with the lowest gestational ages. This kind of approach might anyhow facilitate the transport of the baby from a peripheral delivery-room to few equipped neonatal intensive care units to be created.

摘要

目的

在一个研究时婴儿机械通气设备短缺且新生儿死亡率极高的发展中国家,评估在产房给早产儿使用表面活性剂对呼吸窘迫综合征(RDS)、短期(28天)死亡率及转归的影响。

设计

将罗马尼亚4家医院中孕龄28 - 33周的婴儿随机分为两组,一组在产房接受猪肺表面活性剂预防治疗(气管内给予200mg/kg),另一组接受常规辅助治疗。随机分组后,如有条件可给予补充氧气和持续气道正压通气。不允许进行抢救治疗。RDS的诊断依据是24小时内Silverman评分≥3分且补充氧气需求≥40%。其他检查根据当地实际情况进行。

结果

分析了53例婴儿,28例接受预防治疗,25例作为对照。两组在孕龄、出生体重(预防治疗组和对照组婴儿的平均值分别为:30.6±1.6周对30.2±1.7周,1457±258g对1397±388g)、性别、分娩方式及阿氏评分方面无差异。预防治疗组和对照组0 - 28天的死亡率分别为42.8%和48%(p = 无统计学意义),两组主要死亡原因均为颅内出血。接受表面活性剂治疗的婴儿死亡时间倾向于比对照组晚。与对照组相比,接受预防治疗的婴儿在最初24小时内Silverman评分显著降低(p < 0.05),且在出生后前三天,接受表面活性剂治疗的婴儿的PaO2/FiO2比值几乎持续高于对照组婴儿,尽管差异不显著。

结论

我们的数据证实,在产房用表面活性剂预防RDS能够改善婴儿的临床状况,然而,在没有新生儿重症监护充分支持的情况下,它并不能解决最低孕龄婴儿的生存问题及不良转归。不过,这种方法无论如何可能有助于将婴儿从周边产房转运至为数不多的配备完善的新生儿重症监护病房。

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Update of minimally invasive surfactant therapy.微创表面活性剂治疗的最新进展。
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Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD003063. doi: 10.1002/14651858.CD003063.pub3.