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出生时的表面活性剂替代疗法:一项临床试验的最终分析及与类似试验的比较

Surfactant replacement therapy at birth: final analysis of a clinical trial and comparisons with similar trials.

作者信息

Kendig J W, Notter R H, Cox C, Aschner J L, Benn S, Bernstein R M, Hendricks-Munoz K, Maniscalco W M, Metlay L A, Phelps D L

机构信息

Department of Pediatrics (Neonatology), University of Rochester School of Medicine, New York.

出版信息

Pediatrics. 1988 Nov;82(5):756-62.

PMID:3054783
Abstract

A randomized trial of surfactant replacement therapy at birth was conducted at the University of Rochester between June 1983 and November 1985. Thirty-four premature infants, 25 to 29 weeks' gestational age, received a preventilatory dose of a calf lung surfactant extract in saline prepared at the University of Rochester. A control group of 31 infants received a preventilatory dose of saline alone. The major finding of this trial is that a single preventilatory dose of calf lung surfactant extract reduces the severity of the respiratory distress syndrome during the first 24 hours of life. The beneficial effects, however, are not sustained in many infants and diminish after 24 hours of life. The survival rate was 71% in both the control and surfactant-treated groups. There was a lower incidence of pneumothorax in the surfactant-treated group. There were no differences in the incidence of bronchopulmonary dysplasia, patent ductus arteriosus, and intraventricular hemorrhage. No adverse effects of surfactant replacement therapy were identified. Results of this study suggest that multiple postventilatory doses of surfactant will be required for optimal therapy.

摘要

1983年6月至1985年11月期间,罗切斯特大学进行了一项关于出生时表面活性剂替代疗法的随机试验。34名孕周为25至29周的早产儿接受了罗切斯特大学制备的小牛肺表面活性剂提取物生理盐水预防性剂量。31名婴儿的对照组仅接受了生理盐水预防性剂量。该试验的主要发现是,单次预防性剂量的小牛肺表面活性剂提取物可降低出生后24小时内呼吸窘迫综合征的严重程度。然而,许多婴儿的有益效果并未持续,且在出生24小时后减弱。对照组和表面活性剂治疗组的存活率均为71%。表面活性剂治疗组气胸的发生率较低。支气管肺发育不良、动脉导管未闭和脑室内出血的发生率没有差异。未发现表面活性剂替代疗法的不良反应。这项研究的结果表明,最佳治疗需要多次通气后剂量的表面活性剂。

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