Synthetic surfactant for respiratory distress syndrome in preterm infants

  • Review
  • Intervention

Authors

  • Roger Soll

    Corresponding author
    1. University of Vermont, Division of Neonatal-Perinatal Medicine, Burlington, Vermont, USA
    • Roger Soll, Division of Neonatal-Perinatal Medicine, University of Vermont, Fletcher Allen Health Care, Smith 552A, 111 Colchester Avenue, Burlington, Vermont, 05401, USA. Roger.Soll@vtmednet.org.

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Abstract

Background

This section is under preparation and will be included in the next issue.

Objectives

To assess the effect of intratracheal administration of synthetic surfactant in premature newborns with established respiratory distress syndrome (RDS).

Search methods

Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactants; limits: age groups, newborn infant; publication types, clinical trial), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language.

Selection criteria

Randomized controlled trials which compared the effect of synthetic surfactant treatment to routine management in the treatment of preterm infants with respiratory distress syndrome.

Data collection and analysis

Data regarding clinical outcome including the incidence of pneumothorax, pulmonary interstitial emphysema, pulmonary hemorrhage, patent ductus arteriosus, necrotizing enterocolitis, apnea of prematurity, intraventricular hemorrhage (any grade, and severe intraventricular hemorrhage), bronchopulmonary dysplasia, neonatal mortality, bronchopulmonary dysplasia or death, retinopathy of prematurity (any retinopathy, and retinopathy greater than Stage 3), mortality at hospital discharge, mortality to one year of age, and cerebral palsy (any, and moderate/severe cerebral palsy) was excerpted from the report of the clinical trials by the reviewer. Data were analyzed according to the standards of the Cochrane Neonatal Review Group.

Main results

Six randomized controlled trials of synthetic surfactant treatment of established respiratory distress syndrome were identified. Five of the studies used Exosurf Neonatal (a synthetic surfactant composed of dipalmitoylphosphatidylcholine, hexadecanol and tyloxapol); one small study utilized a mixture of dipalmitoylphosphatidylcholine (DPPC) and phosphatidylglycerol (PG). Treatment with intratracheal Exosurf Neonatal in premature infants with established respiratory distress syndrome improves pulmonary gas exchange and decreases the requirement for ventilatory support. In individual trials, the use of Exosurf Neonatal resulted in a statistically significant reduction in pneumothorax, patent ductus arteriosus, bronchopulmonary dysplasia (BPD), BPD or death at 28 days, and mortality. Similar results are seen when these large trials of Exosurf Neonatal are analyzed in conjunction with the smaller trial of dry powdered DPPC and phosphatidylglycerol (PG). The meta-analysis supports a decrease in the risk of pneumothorax (typical relative risk 0.64, 95% CI 0.55, 0.76, typical risk difference -0.09, 95% CI -0.12,-0.06), a decrease in the risk of pulmonary interstitial emphysema (typical relative risk 0.62, 95% CI 0.54, 0.71, typical risk difference -0.12, 95% CI -0.16, -0.09), a decrease in the risk of patent ductus arteriosus (typical relative risk 0.90, 95% CI 0.84, 0.97; typical risk difference -0.06 95% CI -0.10, -0.02), a decrease in the risk of intraventricular hemorrhage (typical relative risk 0.88, 95% CI 0.77, 0.99; typical risk difference -0.04, 95% CI -0.08, -0.00), a decrease in the risk of bronchopulmonary dysplasia (typical relative risk 0.75, 95% CI 0.61, 0.92; typical risk difference -0.04, 95% CI -0.06, -0.01), a decrease in the risk of neonatal mortality (typical relative risk 0.73, 95% CI 0.61, 0.88; typical risk difference -0.05, 95% CI -0.07, -0.02), a decrease in the risk of bronchopulmonary dysplasia or death at 28 days (typical relative risk 0.73, 95% CI 0.65, 0.83; typical risk difference -0.06, 95% CI -0.11, -0.05), a decrease in the risk of mortality prior to hospital discharge (typical relative risk 0.79, 95% CI 0.68, 0.92; typical risk difference -0.05, 95% CI -0.07, -0.02) and a decrease in the risk of mortality during the first year of life (typical relative risk 0.80, 95% CI 0.69, 0.94; typical risk difference -0.04, 95% CI -0.07, -0.01). Treatment with synthetic surfactant increases the risk of apnea of prematurity (typical relative risk 1.20, 95% CI 1.09, 1.31; typical risk difference 0.08, 95% CI 0.04, 0.12).

Authors' conclusions

Intratracheal administration of synthetic surfactant to infants with established respiratory distress syndrome has been demonstrated to improve clinical outcome. Infants who are treated with synthetic surfactant have a decreased risk of pneumothorax, a decreased risk of pulmonary interstitial emphysema, a decreased risk of intraventricular hemorrhage, a decreased risk of bronchopulmonary dysplasia, a decreased risk of neonatal mortality, a decreased risk of mortality prior to hospital discharge and at 1 year of age. Infants who receive synthetic surfactant treatment for established RDS have an increased risk of apnea of prematurity.

摘要

背景

以合成性表面張力素治療早產兒呼吸窘迫症候群(respiratory distress syndrome)

本節正在準備之中,將列入下一個議題。

目標

為了評估經氣管內給予早產兒合成性表面張力素以治療新生兒呼吸窘迫症候群的功效。

搜尋策略

檢索了牛津周產期試驗數據庫,Medline(醫學標題表:肺表面張力素; 限制:年齡組,新生兒; 出版物類型,臨床試驗),前幾次檢閱包括交叉引用、摘要、會議和研討會論文集,專家信息和英語的手工檢索。

選擇標準

隨機對照試驗以比較使用合成性表面張力素在常規治療新生兒呼吸窘迫症候群的效果

資料收集與分析

和臨床預後有關的數據,包括氣胸、肺間質氣腫、肺出血、開放性動脈導管、壞死性小腸結腸炎、早產兒呼吸暫停、腦室內出血(任何級別和嚴重腦室內出血)、支氣管肺發育不良或死亡、早產兒視網膜病變(任何視網膜病變,和視網膜病變等級大於3)等的發生率、出院時之死亡率、至一歲時之死亡率及腦性麻痺 任何嚴重度和中/重度腦性麻痺)是由審閱者摘自臨床試驗的報告內容。數據分析是根據Cochrane新生兒評估組的標準來作。

主要結論

找到6個隨機對照試驗為合成性表面張力素治療已確立之新生兒呼吸窘迫症候群的研究。其中的5個研究是使用Exosurf Neoatal(一種合成性表面張力素其中包含dipalmitoylphosphatidylcholine、hexadecanol及tyloxapol),另一個小型研究則是利用混合dipalmitoylphosphatidylcholine(DPPC)和 hosphatidylglycerol (PG)。在已確立有新生兒呼吸窘迫症候群的早產兒給予氣管內Exosurf Neonatal可改善肺部氣體交換及降低使用呼吸器的需求。在個別試驗中,使用Exosurf Neonatal的新生兒,統計上顯著可減少氣胸,開放性動脈導管,支氣管肺發育不良(BPD),BPD或28天內死亡及死亡率。當將使用Exosurf Neonatal的大型試驗以及使用粉狀DPP 和 PG 的小型試驗作聯合分析後,也出現類似的結果。該統合分析(metaanalysis)顯示可減少氣胸風險(典型的相對危險度0.64,95%CI為0.55,0.76,典型的風險差−0.09,95%CI為−0.12,−0.06),降低肺間質氣腫的風險(典型的相對危險度0.62,95%CI為0.54,0.71,典型的風險差−0.12,95%CI為−0.16,−0.09),降低開放性動脈導管的風險(典型的相對危險度0.90,95%CI為0.84,0.9 典型的風險差−0.06 95%CI為−0.10,−0.02),降低腦室內出血的風險(典型的相對危險度0.88,95%CI為0.77,0.99;典型的風險差−0.04,95%CI為−0.08, 0.00),降低支氣管肺發育不良的風險(典型的相對危險度0.75,95%CI為0.61,0.92;典型的風險差−0.04,95%CI為−0.06,−0.01),降低新生兒死亡率(典型相對危險度0.73,95%CI為0.61,0.88,典型的風險差−0.05,95%CI為−0.07,−0.02),降低支氣管肺發育不良或28天內死亡的風險(典型的相對危險度0.73,95%CI為0.6 ,0.83;典型的風險差−0.06,95%CI為−0.11,−0.05),降低出院前死亡率(典型的相對危險度為0.79,95%CI為0.68,0.92;典型的風險差−0.05,9 %CI為−0.07,−0.02)和減少一歲期間死亡的風險,(典型的相對危險度0.80,95%CI為0.69,0.94,典型的風險差−0.04,95%CI為−0.07,−0.01) 。使用合成表面張力素會增加早產兒呼吸暫停的風險(典型的相對危險度1.20,95%CI為1.09,1.31,典型的風險差0.08,95%CI為0.04,0.12)。

作者結論

給予合成性表面張力素在已確立具有新生兒呼吸窘迫症候群的嬰兒,已被証實可改善臨床預後。以合成表面張力素治療的嬰兒可減少氣胸發生的風險、降低間質性肺氣腫發生的風險、降低腦室內出血發生的風險、降低支氣管肺發育不良發生的風險,並降低新生兒死亡率和降低出院前及一歲期間死亡的風險。而已確立具有新生兒呼吸窘迫症候群的嬰兒接受合成表面張力素治療,則會增加早產兒呼吸暫停的風險。

翻譯人

本摘要由高雄醫學大學附設醫院楊詠甯翻譯。

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

總結

合成表面張力素可有效地減少早產兒呼吸窘迫症。肺表面張力素是一種能減少表面張力而可防止肺內氣囊塌陷的物質。有時不成熟的肺部缺乏表面張力素便會發生呼吸窘迫症。合成表面張力素已發展可使用於有呼吸窘迫症高危險群的早產嬰兒(34週前)。此臨床報告的回顧發現合成表面張力素能有效治療發生呼吸窘迫症的嬰兒。合成表面張力素能降低發生氣胸(在胸腔中的空氣)和死亡的風險。不管是使用天然或合成性的表面張力素,其惟一之副作用是會使肺出血的(肺內有出血)機會增加。

Plain language summary

Synthetic surfactant for respiratory distress syndrome in preterm infants

Synthetic surfactant is effective in reducing respiratory distress syndrome in preterm babies. Pulmonary surfactant is a substance that prevents the air sacs of the lungs from collapsing by reducing surface tension. Sometimes it is absent in immature lungs and respiratory distress syndrome (RDS) can develop. Synthetic surfactants have been developed and can be used for babies born prematurely (before 34 weeks) who have RDS. The review of trials found evidence that synthetic surfactant for babies with RDS is effective. Synthetic surfactant reduced the risk of pneumothorax (air in the lung cavity) and death. The only adverse effect is the increased risk of pulmonary hemorrhage (bleeding in the lungs), seen with the use of either synthetic or natural surfactant.

Ringkasan bahasa mudah

Surfaktan sintetik untuk 'respiratory distress syndrome' di kalangan bayi pramatang.

Surfaktan sintetik adalah berkesan dalam mengurangkan 'respiratory distress syndrome' di kalangan bayi pramatang. Surfaktan pulmonari adalah bahan yang mencegah pundi-pundi udara dalam paru-paru daripada 'runtuh' dengan mengurangkan ketegangan permukaan. Kekadang bahan ini tidak didapati dalam paru-paru yang belum matang dan menyebabkan 'respiratory distress syndrome' (RDS). Surfaktan sintetik telah dihasilkan dan boleh digunakan untuk bayi yang dilahirkan pramatang (sebelum 34 minggu) dengan RDS. Ulasan kajian-kajian mendapati bukti yang sufaktan sintetik berkesan untuk bayi dengan RDS. Surfaktan sintetik mengurangkan risiko pneumothorax (udara dalam kaviti paru-paru) dan kematian. Saru-satunya kesan buruk yang didapati ialah peningkatan risiko hemoraj paru-paru (perdarahan dalam paru-paru), yang kelihatan samada dengan penggunaan surfaktan sintetik atau asli.

Catatan terjemahan

Diterjemahkan oleh Foo Sook Lee (Penang Medical College). Disunting oleh Tan May Loong (Penang Medical College). Untuk sebarang pertanyaan mengenai terjemahan ini sila hubungi fslee@pmc.edu.my. 

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