Abdel-Latif Mohamed E, Osborn David A
Department of Neonatology, Australian National University Medical School, Woden, Australia.
Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD008310. doi: 10.1002/14651858.CD008310.pub2.
Nebulised surfactant has the potential to deliver surfactant to the infant lung with the goal of avoiding endotracheal intubation and ventilation, ventilator-induced lung injury and bronchopulmonary dysplasia (BPD).
To determine the effect of nebulised surfactant administration either as prophylaxis or treatment compared to placebo, no treatment or intratracheal surfactant administration on morbidity and mortality in preterm infants with, or at risk of, respiratory distress syndrome (RDS).
Searches were performed of CENTRAL (The Cochrane Library, January 2012), MEDLINE and PREMEDLINE (1950 to January 2012), EMBASE (1980 to January 2012) and CINAHL (1982 to January 2012), as well as proceedings of scientific meetings, clinical trial registries, Google Scholar and reference lists of identified studies. Expert informants and surfactant manufacturers were contacted.
Randomised, cluster-randomised or quasi-randomised controlled trials of nebulised surfactant administration compared to placebo, no treatment, or other routes of administration (laryngeal, pharyngeal instillation of surfactant before the first breath, thin endotracheal catheter surfactant administration or intratracheal surfactant instillation) on morbidity and mortality in preterm infants at risk of RDS. We considered published, unpublished and ongoing trials.
Two review authors independently assessed studies for eligibility and quality, and extracted data.
No studies of prophylactic or early nebulised surfactant administration were found. A single small study of late rescue nebulised surfactant was included. The study is of moderate risk of bias. The study enrolled 32 preterm infants born < 36 weeks' gestation with RDS on nasal continuous positive airway pressure (nCPAP). The study reported no significant difference between nebulised surfactant administration compared to no treatment groups in chronic lung disease (risk ratio (RR) 5.00; 95% confidence interval (CI) 0.26 to 96.59) or other outcomes (oxygenation 1 to 12 hours after randomisation, need for mechanical ventilation, days of mechanical ventilation or continuous positive airways pressure (CPAP) or days of supplemental oxygen). No side effects of the nebulised surfactant therapy or aerosol inhalation were reported.
AUTHORS' CONCLUSIONS: There are insufficient data to support or refute the use of nebulised surfactant in clinical practice. Adequately powered trials are required to determine the effect of nebulised surfactant administration for prevention or early treatment of RDS in preterm infants. Nebulised surfactant administration should be limited to clinical trials.
雾化表面活性物质有将其输送至婴儿肺部的潜力，目的是避免气管插管和机械通气、呼吸机相关性肺损伤及支气管肺发育不良（BPD）。
确定与安慰剂、不治疗或气管内注入表面活性物质相比，雾化吸入表面活性物质作为预防或治疗措施对患有或有呼吸窘迫综合征（RDS）风险的早产儿发病率和死亡率的影响。
检索了Cochrane系统评价数据库（CENTRAL，2012年1月）、医学文献数据库（MEDLINE）和医学预印本数据库（PREMEDLINE，1950年至2012年1月）、荷兰医学文摘数据库（EMBASE，1980年至2012年1月）和护理学与健康领域数据库（CINAHL，1982年至2012年1月），以及科学会议论文集、临床试验注册库、谷歌学术和纳入研究的参考文献列表。联系了专家线人和表面活性物质制造商。
将雾化吸入表面活性物质与安慰剂、不治疗或其他给药途径（首次呼吸前经喉、咽注入表面活性物质、细气管内导管注入表面活性物质或气管内注入表面活性物质）进行比较的随机、整群随机或半随机对照试验，观察对象为有RDS风险的早产儿的发病率和死亡率。我们考虑了已发表、未发表及正在进行的试验。
两位综述作者独立评估研究的合格性和质量，并提取数据。
未找到关于预防性或早期雾化吸入表面活性物质的研究。纳入了一项关于晚期挽救性雾化吸入表面活性物质的小型研究。该研究存在中度偏倚风险。该研究纳入了32例孕周<36周、患有RDS且接受鼻持续气道正压通气（nCPAP）的早产儿。该研究报告称，与未治疗组相比，雾化吸入表面活性物质组在慢性肺病（风险比（RR）5.00；95%置信区间（CI）0.26至96.59）或其他结局（随机分组后1至12小时的氧合、机械通气需求、机械通气天数或持续气道正压通气（CPAP）天数或补充氧气天数）方面无显著差异。未报告雾化表面活性物质治疗或雾化吸入的副作用。
目前尚无足够数据支持或反驳在临床实践中使用雾化表面活性物质。需要开展有足够效力的试验来确定雾化吸入表面活性物质对预防或早期治疗早产儿RDS的效果。雾化吸入表面活性物质应仅限于临床试验。
