Intervention Review

Animal derived surfactant extract for treatment of respiratory distress syndrome

  1. Nadine Seger1,*,
  2. Roger Soll2

Editorial Group: Cochrane Neonatal Group

Published Online: 15 APR 2009

Assessed as up-to-date: 13 FEB 2009

DOI: 10.1002/14651858.CD007836


How to Cite

Seger N, Soll R. Animal derived surfactant extract for treatment of respiratory distress syndrome. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD007836. DOI: 10.1002/14651858.CD007836.

Author Information

  1. 1

    University of Vermont College of Medicine, Department of Pediatrics, Burlington, Vermont, USA

  2. 2

    University of Vermont, Division of Neonatal-Perinatal Medicine, Burlington, Vermont, USA

*Nadine Seger, Department of Pediatrics, University of Vermont College of Medicine, McClure 7, Fletcher Allen Health Care, 111 Colchester Avenue, Burlington, Vermont, 05401, USA. nadineseger@yahoo.com.

Publication History

  1. Publication Status: New
  2. Published Online: 15 APR 2009

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Respiratory distress syndrome (RDS) is caused by a deficiency or dysfunction of pulmonary surfactant. A wide variety of surfactant products have been formulated and studied in clinical trials. These include synthetic surfactants and animal derived surfactant extracts. Trials of surfactant replacement have either tried to prevent the development of respiratory distress in high-risk premature infants or treat established respiratory distress in premature infants.

Objectives

To assess the effect of administration of animal derived surfactant extract on mortality, chronic lung disease and other morbidities associated with prematurity in preterm infants with established respiratory distress syndrome. Subgroup analysis were planned according to the specific surfactant product, the degree of prematurity, and the severity of disease.

Search methods

Searches were made of the Oxford Database of Perinatal Trials, MEDLINE, EMBASE, and CINAHL from 1975 through December 2008. In addition, searches were made of previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants and journal hand searching in the English language.

Selection criteria

Randomized or quazi-randomized controlled trials that compared the effect of animal derived surfactant extract treatment administered to infants with established respiratory distress syndrome in order to prevent complications of prematurity and mortality.

Data collection and analysis

Data regarding clinical outcomes were excerpted from the reports of the clinical trials by the review authors. Data analysis was done in accordance with the standards of the Cochrane Neonatal Review Group.

Main results

Thirteen randomized controlled trials were included in the analysis. The studies demonstrated an initial improvement in respiratory status (improved oxygenation and decreased need for ventilator support). The meta-analysis supports a significant decrease in the risk of any air leak (typical relative risk 0.47, 95% CI 0.39, 0.58; typical risk difference -0.16, 95% CI -0.21, -0.12), pneumothorax (typical relative risk 0.42, 95% CI 0.34, 0.52; typical risk difference -0.17, 95% CI -0.21, -0.13), and a significant decrease in the risk of pulmonary interstitial emphysema (typical relative risk 0.45, 95% CI 0.37, 0.55; typical risk difference -0.20, 95% CI -0.25, -0.15). There is a significant decrease in the risk of neonatal mortality (typical relative risk 0.68, 95% CI 0.57, 0.82; typical risk difference -0.09, 95% CI -0.13, -0.05), a significant decrease in the risk of mortality prior to hospital discharge (typical relative risk 0.63, 95% CI 0.44, 0.90; typical risk difference -0.10, 95% CI -0.18, -0.03) and a significant decrease in the risk of bronchopulmonary dysplasia (BPD) or death at 28 days of age (typical relative risk 0.83, 95% CI 0.77, 0.90; typical risk difference -0.11, 95 CI -0.16, -0.06). No differences are reported in the risk of patent ductus arteriosus, necrotizing enterocolitis, intraventricular hemorrhage, BPD or retinopathy of prematurity.

Authors' conclusions

Infants with established respiratory distress syndrome who receive animal derived surfactant extract treatment have a decreased risk of pneumothorax, a decreased risk of pulmonary interstitial emphysema, a decreased risk of mortality, and a decreased risk of bronchopulmonary dysplasia or death.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Animal derived surfactant extract treatment for respiratory distress syndrome

Respiratory distress syndrome (RDS) is caused by a deficiency or dysfunction of the lining chemicals of the lung known as pulmonary surfactant. A wide variety of surfactant products have been formulated and studied in clinical trials. These include synthetic surfactants and animal derived surfactant extracts. Animal derived surfactant extracts are obtained from animal or human sources. Trials of surfactant replacement have either tried to prevent the development of respiratory distress in high-risk premature infants or treat established respiratory distress in premature infants. Infants with established respiratory distress syndrome who receive animal derived surfactant extract treatment have a decreased risk of lung rupture (pneumothorax), a decreased risk of lung injury (pulmonary interstitial emphysema), a decreased risk of dying, and a decreased risk of chronic lung injury (bronchopulmonary dysplasia) or death.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

取自動物的表面張力素萃取物在呼吸窘迫症的治療

呼吸窘迫症是由於肺部的表面張力素缺乏或功能不佳造成。多種的表面張力素產品被製造並試驗過,這些包含合成性的表面張力素和來自動物的表面張力素萃取物。表面張力素替換物的試驗已被用在預防高風險早產兒產生或治療已有呼吸窘迫的早產兒。

目標

評估給予取自動物的表面張力素萃取物對早產兒在死亡率、慢性肺疾病和其他有關的疾病的效果。另針對特定表面張力素製品、早產程度和疾病嚴重度做次族群分析。

搜尋策略

我們搜索自1975至2008年12月Oxford Database of Perinatal Trials, MEDLINE, EMBASE,與CINAHL。另外我們也搜尋 先前回顧 (包括交叉引用參考文獻、摘要、會議與學術討論會會報),專家報導與手工搜尋英文期刊。

選擇標準

隨機或類隨機對照試驗,對呼吸窘迫症嬰兒比較給予動物萃取的表面張力素,來預防早產的併發症和死亡。

資料收集與分析

關於臨床結果的數據被作者從臨床試驗報告中節錄,並依據Cochrane Neonatal Review Group的標準分析數據。

主要結論

共納入13個隨機對照試驗。它們顯示對呼吸狀態初期有改善(氧合能力和減少呼吸器需求)。統合分析顯示下列結果都顯著風險降低:任何氣體滲漏(典型相對風險0.47, 95%信賴區間 0.39, 0.58;典型風險差 −0.16, 95% CI −0.21, −0.12),氣胸(典型相對風險0.42, 95%信賴區間0.34, 0.52; 典型風險差−0.17, 95%信賴區間−0.21, −0.13),肺間質氣腫(典型相對風險0.45, 95%信賴區間0.37, 0.55; 典型風險差−0.20, 95%信賴區間−0.25, −0.15),新生兒死亡率(典型相對風險0.68, 95%信賴區間0.57, 0.82; 典型風險差−0.09, 95%信賴區間−0.13, −0.05),出院後死亡(典型相對風險0.63, 95%信賴區間0.44, 0.90; 典型風險差−0.10, 95%信賴區間−0.18, −0.03),28天死亡率(典型相對風險0.83, 95%信賴區間0.77, 0.90; 典型風險差−0.11, 95信賴區間 −0.16, −0.06)。以下是沒有顯著差異的:動脈導管未閉、壞死性腸炎、腦室內出血、肺支氣管生長不全或早產兒視網膜病變。

作者結論

呼吸窘迫症的嬰兒接受取自動物表面張力素萃取物後可減少氣胸、肺間質氣腫、肺支氣管發育或死亡的風險。

翻譯人

本摘要由臺中榮民總醫院薛榮華翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

呼吸窘迫症是由於肺部表面張力素不足或功能不佳。多種表面張力素產品被製造並試驗過,包含合成表面張力素和來自動物的表面張力素萃取物。動物性表面張力素萃取物是來自於人類或動物。表面張力素替換物試驗已被用在預防或治療早產兒呼吸窘迫。呼吸窘迫症的嬰兒在接受動物表面張力素萃取物後可減少肺部破裂(氣胸)、肺部受傷(肺間質氣腫)、慢性肺傷害(肺支氣管發育不全) 和死亡的風險。