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Protein-containing synthetic surfactant versus protein-free synthetic surfactant for the prevention and treatment of respiratory distress syndrome

  • Review
  • Intervention

Authors


Abstract

Background

Respiratory distress syndrome (RDS) is a significant cause of morbidity and mortality in preterm infants. RDS is caused by a deficiency, dysfunction, or inactivation of pulmonary surfactant. Numerous surfactants of either animal extract or synthetic design have been shown to improve outcomes. New surfactant preparations that include peptides or whole proteins that mimic endogenous surfactant protein have recently been developed and tested.

Objectives

To assess the effect of administration of synthetic surfactant containing surfactant protein mimics compared to protein free synthetic surfactant on the risk of mortality, chronic lung disease, and other morbidities associated with prematurity in preterm infants at risk for or having RDS.

Search methods

Standard search methods of the Cochrane Neonatal Review Group were used. The search included MEDLINE (1966 - March 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) in all languages.

Selection criteria

Randomized and quasi-randomized controlled clinical trials were considered for this review. Studies that enrolled preterm infants or low birth weight infants at risk for or having RDS who were treated with either a synthetic surfactant containing surfactant protein mimics or a protein free synthetic surfactant were included for this review. Studies of treatment or prevention of respiratory distress syndrome were included.

Data collection and analysis

Data regarding mortality, chronic lung disease and multiple secondary outcome measures were abstracted by the review authors. Statistical analysis was performed using Review Manager software. Categorical data were analyzed using relative risk, risk difference, and number needed to treat. 95% confidence intervals reported. A fixed effects model was used for the meta-analysis. Heterogeneity was assessed using the I2 statistic.

Main results

One study was identified that compared protein containing synthetic surfactants (PCSS) to protein free synthetic surfactants. Infants who received protein containing synthetic surfactant compared to protein free synthetic surfactant did not demonstrate significantly different risks of prespecified primary outcomes: mortality at 36 weeks postmenstrual age (PMA) [RR 0.89 (95% CI 0.71, 1.11)], chronic lung disease at 36 weeks PMA [RR 0.89 (95% CI 0.78, 1.03)], or the combined outcome of mortality or chronic lung disease at 36 weeks PMA [RR 0.88 (95% CI 0.77, 1.01)]. Among the secondary outcomes, a decrease in the incidence of respiratory distress syndrome at 24 hours of age was demonstrated in the group that received PCSS [RR 0.83 (95% CI 0.72, 0.95).

Authors' conclusions

In the one trial comparing protein containing synthetic surfactants compared to protein free synthetic surfactant for the prevention of RDS, no statistically different clinical differences in death and chronic lung disease were noted. Clinical outcomes between the two groups were generally similar although the group receiving protein containing synthetic surfactants did have decreased incidence of respiratory distress syndrome. Further well designed studies comparing protein containing synthetic surfactant to the more widely used animal derived surfactant extracts are indicated.

摘要

背景

含有蛋白質或不含蛋白質的表面張力素對呼吸窘迫症預防及治療之比較

呼吸窘迫症 (RDS) 是一種常見引起早產兒疾病和死亡的原因。RDS是由於肺部表面張力素缺乏、功能不佳或不活化所引起。多種從動物萃取或合成的表面張力素對於疾病的預後改善都有幫助。近來有新的 (包括為胜?或含有完整蛋白質) 表面張力素被發展出並進行測試中。

目標

為了評估含有類似表面張力素蛋白質成分和不含蛋白質成分這兩種合成的表面張力素對於有RDS的早產兒在死亡率、慢性肺疾病和其他疾病的效果。

搜尋策略

採用Cochrane Neonatal Review Group的標準搜尋方法。搜尋的範圍包括MEDLINE (1966  March 2009) 和the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) 上各種語言的試驗。

選擇標準

採用隨機或近隨機且有限制的臨床試驗會被考慮納入評估。被納入評估的試驗是對象為有RDS危險或有RDS的早產或低體重兒,接受了含有類似表面張力素蛋白質成分或不含蛋白質成分這兩種合成的表面張力素治療。包括研究RDS的治療或預防之試驗皆納入。

資料收集與分析

作者評估和死亡、慢性肺疾病及多種繼發結果相關的資料。採用Review Manager軟體來做統計分析。分類資料以相關危險性、危險差異和需要治療的人數來統計分析,以95% 信賴區間來報告。使用固定效果模型來做綜合分析。我們用了12 static來評估變異性。

主要結論

其中一個研究比較接受含有蛋白質成分或不含蛋白質成分這兩種合成的表面張力素的嬰兒,在未特定主要的預後項目:受孕36週大時的死亡率[RR 0.89 (95% CI 0.71, 1.11)]、慢性肺疾病的發生率[RR 0.89 (95% CI 0.78, 1.03)]、或兩者的合併結果上,並無顯著差異。在次發的預後項目中,接受含有蛋白質成分表面張力素的嬰兒在出生24小時大時發生RDS的機率較低[RR 0.83 (95% CI 0.72, 0.95)]。

作者結論

在另一個研究中,含蛋白質成分或不含蛋白質成分這兩種合成的表面張力素對於RDS在死亡和慢性肺疾病這兩項因子上並無統計上顯著的差異。這兩組在臨床上的結果大致上是相似的,雖然接受含蛋白表面張力素的嬰兒在出生24小時大時發生RDS的機率是比較低的。應再設計研究來比較合成和由動物萃取的表面張力素之差異。

翻譯人

本摘要由馬偕醫院林千裕翻譯。

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

總結

比較含蛋白與不含蛋白兩種合成的表面張力素在對呼吸窘迫症的預防及治療效果: 呼吸窘迫症 (RDS) 在早產兒的疾病中是很重要的一個原因。RDS是由於肺部的一種化學物質即肺部表面張力素缺乏或功能不佳所引起。有多種從動物萃取或合成的表面張力素被發展出並進行測試以用來治療或預防呼吸窘迫症。普遍來說,這些表面張力素的產品能減少肺部破裂 (氣胸) 和死亡的機率,並使肺部沒有受傷的生存者人數增加。根據之前的研究,從動物萃取的表面張力素似乎比合成的表面張力素來得有效。這可能是因為以往的表面張力素中並沒有動物性表面張力素中含有的蛋白質。近來被發展出來的合成表面張力素包括含有完整蛋白質或部分蛋白質 (稱為胜?) 兩種,他們的表現就像自然的表面張力素蛋白一樣。這些製品最近有被拿來和不含蛋白質的表面張力素作比較。最近一個這樣的試驗提出含蛋白質的表面張力素能幫忙預防呼吸窘迫症,也或許或不能減少肺部的傷害 (慢性肺疾病) 。其他試驗的結果也大同小異。還有更近一步的研究能幫助定義含蛋白的表面張力素在使用上的建議。

Plain language summary

Protein-containing synthetic surfactant versus protein-free synthetic surfactant for the prevention and treatment of respiratory distress syndrome

Respiratory distress syndrome (RDS) is a significant cause of illness in preterm infants. RDS is caused by a deficiency or a dysfunction of the chemicals that line the lung, called pulmonary surfactant. Numerous preparations that contain surfactants of either animal origin or synthetic design have been developed and tested to treat or prevent RDS. In general, these surfactant preparations have decreased lung rupture (pneumothorax), decreased the risk of dying, and increased the number of survivors without lung damage. From previous research, the surfactants that are obtained from animal lungs seem to have a better effect than the synthetic surfactants. This might be due to the surfactant proteins contained in animal surfactant that are absent in the previously available synthetic surfactants. 

Recently developed synthetic surfactant preparations include whole surfactant proteins or parts of the proteins (called peptides) that act like naturally occurring surfactant protein. These preparations have been recently tested in comparison to the protein free synthetic surfactant preparations. 

A recent trial of protein containing synthetic surfactant compared to protein free synthetic surfactant suggests that these protein containing synthetic surfactants help prevent respiratory distress syndrome and may or may not lead to a decrease in lung injury (chronic lung disease). Other clinical outcomes were similar. Further studies will help refine recommendations concerning use of protein containing synthetic surfactants.

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