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产前地塞米松治疗联合人表面活性剂挽救治疗:一项随机安慰剂对照多中心研究。

Prenatal dexamethasone treatment in conjunction with rescue therapy of human surfactant: a randomized placebo-controlled multicenter study.

作者信息

Kari M A, Hallman M, Eronen M, Teramo K, Virtanen M, Koivisto M, Ikonen R S

机构信息

Children's Hospital, University of Helsinki, Finland.

出版信息

Pediatrics. 1994 May;93(5):730-6.

PMID:8165070
Abstract

OBJECTIVES

A placebo-controlled, randomized, double-blind study was performed to determine whether prenatal dexamethasone (DEX) treatment improves the outcome of the preterm infant when exogenous surfactant is available.

METHODS

157 pregnant women at five hospitals with threatened preterm delivery and with lengths of gestation < 32 weeks received either DEX (dose 6 mg four times at 12-hour intervals) or placebo (PL). Prenatal treatment was not repeated. Preterm infants received rescue therapy of human surfactant (maximum four doses) if they required ventilatory support and at least 40% oxygen for the treatment of respiratory distress syndrome (RDS).

RESULTS

Enrolled pregnant women delivered 188 live-born neonates, of whom 79 (DEX 41 and PL 38 neonates) were born 1 to 14 days after the prenatal treatment. Neonates born within 1 to 14 days after the initial DEX treatment had a lower incidence of RDS (DEX, 44%; PL, 79%; P < .01), lower requirements of surfactant (DEX, 22%; PL, 53%; P < .01), shorter duration of ventilatory support (DEX, 2.0 days; PL, 5.3 days; P < .05) and oxygen therapy (DEX, 2.0 days; PL, 7.0 days; P < .01), and a higher neonatal survival without ventilatory support (P < .05) than PL-treated neonates. DEX-treated neonates had higher mean blood pressure than PL-treated neonates during the first 3 days after birth. Among all neonates treated with DEX, there was a lower incidence of intraventricular hemorrhage or periventricular leucomalacia (DEX, 13%; PL, 33%; P < .01). Reduction in the incidence of intraventricular hemorrhage or periventricular leucomalacia in DEX-treated neonates was particularly associated with exogenous human surfactant therapy (DEX+surfactant 10%; PL+surfactant 48%; P < .01).

CONCLUSIONS

Prenatal DEX treatment combined with exogenous human surfactant therapy in preterm infants decreases pulmonary morbidity and cerebral complications, and increases survival without severe morbidity.

摘要

目的

进行一项安慰剂对照、随机、双盲研究,以确定在有外源性表面活性剂的情况下,产前地塞米松(DEX)治疗是否能改善早产婴儿的预后。

方法

五家医院的157名有早产风险且孕周<32周的孕妇,接受了DEX(剂量6mg,每12小时一次,共四次)或安慰剂(PL)治疗。产前治疗未重复进行。早产婴儿如果需要通气支持且至少40%氧气用于治疗呼吸窘迫综合征(RDS),则接受人表面活性剂的抢救治疗(最大四剂)。

结果

入组孕妇分娩了188名活产新生儿,其中79名(DEX组41名,PL组38名新生儿)在产前治疗后1至14天出生。在初次DEX治疗后1至14天内出生的新生儿,RDS发生率较低(DEX组44%;PL组79%;P<.01),表面活性剂需求量较低(DEX组22%;PL组53%;P<.01),通气支持持续时间较短(DEX组2.0天;PL组5.3天;P<.05)和氧疗时间较短(DEX组2.0天;PL组7.0天;P<.01),且无通气支持的新生儿存活率较高(P<.05)。DEX治疗的新生儿在出生后的头3天平均血压高于PL治疗的新生儿。在所有接受DEX治疗的新生儿中,脑室内出血或脑室周围白质软化的发生率较低(DEX组13%;PL组33%;P<.01)。DEX治疗的新生儿脑室内出血或脑室周围白质软化发生率的降低尤其与外源性人表面活性剂治疗相关(DEX+表面活性剂组10%;PL+表面活性剂组48%;P<.01)。

结论

早产婴儿产前DEX治疗联合外源性人表面活性剂治疗可降低肺部发病率和脑部并发症,并提高无严重疾病的存活率。

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