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动物来源的表面活性剂治疗和预防新生儿呼吸窘迫综合征:临床试验总结。

Animal-derived surfactants for the treatment and prevention of neonatal respiratory distress syndrome: summary of clinical trials.

机构信息

Department of Neonatology, Southeast Area Health Educational Center, New Hanover Regional Medical Center, Wilmington, NC, USA.

出版信息

Ther Clin Risk Manag. 2009 Feb;5(1):251-60. doi: 10.2147/tcrm.s4029. Epub 2009 Mar 26.

Abstract

INTRODUCTION

Available literature suggests that the advantage of animal-derived surfactants over first-generation synthetic agents derives from the presence of surface-active proteins and their phospholipid content. Here we summarize the results of clinical trials comparing animal-derived surfactant preparations with other animal-derived surfactants and with both first-and second-generation synthetic surfactants.

METHODS

Published clinical trials of comparisons of animal-derived surfactants were summarized and compared. Comparisons emphasized differences in (1) key surfactant components attributed with efficacy and (2) differences in published outcomes.

RESULTS

For the most important outcomes, mortality and chronic lung disease, currently available natural surfactants are essentially similar in efficacy. When examining secondary outcomes (pneumothorax, ventilator weaning, and need for supplemental oxygen), it appears that both calfactant and poractant have an advantage over beractant. The weight of the evidence, especially for study design and secondary outcomes, favors the use of calfactant. However, the superiority of poractant over beractant, when the higher initial dose of poractant is used, strengthens the case for use of poractant as well.

CONCLUSIONS

Clinical trials suggest that the higher surfactant protein-B content in calfactant, and perhaps the higher phospholipid content in poractant (at higher initial dose), are the factors that most likely confer the observed advantage over other surfactant preparations.

摘要

简介

现有文献表明,动物源性表面活性剂相对于第一代合成制剂的优势源自表面活性蛋白及其磷脂含量。本文总结了比较动物源性表面活性剂制剂与其他动物源性表面活性剂以及第一代和第二代合成表面活性剂的临床试验结果。

方法

总结并比较了已发表的比较动物源性表面活性剂的临床试验。比较强调了(1)与疗效相关的关键表面活性剂成分和(2)已发表结果的差异。

结果

对于最重要的结局(死亡率和慢性肺病),目前可用的天然表面活性剂在疗效上基本相似。当检查次要结局(气胸、呼吸机撤机和需要补充氧气)时,似乎 calfactant 和 poractant 都优于 beractant。证据的权重,特别是在研究设计和次要结局方面,支持使用 calfactant。然而,当使用较高的 poractant 初始剂量时,poractant 优于 beractant,这也加强了使用 poractant 的理由。

结论

临床试验表明,calfactant 中较高的表面活性蛋白-B 含量,以及 poractant(在较高初始剂量时)中较高的磷脂含量,很可能是赋予其相对于其他表面活性剂制剂的观察到的优势的因素。

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