Aziz Abdul, Ohlsson Arne
William Osler Health Centre, Department of Pediatrics, 20 Lynch Street, Brampton, ON, Canada, L6W 2Z8.
University of Toronto, Departments of Paediatrics, Obstetrics and Gynaecology and Institute of Health Policy, Management and Evaluation, Toronto, Canada.
Cochrane Database Syst Rev. 2020 Feb 3;2(2):CD005254. doi: 10.1002/14651858.CD005254.pub4.
In the 1960s and 1970s, pulmonary haemorrhage (PH) occurred mainly in full-term infants with pre-existing illness with an incidence of 1.3 per 1000 live births. Risk factors for PH included severity of illness, intrauterine growth restriction, patent ductus arteriosus (PDA), coagulopathy and the need for assisted ventilation. Presently, PH occurs in 3% to 5% of preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. The cause of PH is thought to be due to rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a PDA and an increase in pulmonary blood flow. Retrospective case reports and one prospective uncontrolled study have shown promising results for surfactant in treating PH.
To evaluate the effect of surfactant treatment compared to placebo or no intervention on mortality and morbidities in neonates with PH.
For this update The Cochrane Library, Issue 2, 2012; MEDLINE; EMBASE; CINAHL; Clinicaltrials.gov; Controlled-trials.com; proceedings (2000 to 2011) of the Annual Meetings of the Pediatric Academic Societies (Abstracts2View) and Web of Science were searched on 8 February 2012.
Randomised or quasi-randomised controlled trials that evaluated the effect of surfactant in the treatment of PH in intubated term or preterm (< 37 weeks) neonates with PH. Infants were included up to 44 weeks' postmenstrual age. The interventions studied were intratracheal instillation of surfactant (natural or synthetic, regardless of dose) versus placebo or no intervention.
If studies were identified by the literature search, the planned analyses included risk ratio, risk difference, number needed to treat to benefit or to harm for dichotomous outcomes, and mean difference for continuous outcomes, with their 95% confidence intervals. A fixed-effect model would be used for meta-analyses. The risk of bias for included trials would be assessed. Heterogeneity tests, including the I statistic, would be performed to assess the appropriateness of pooling the data and the results would be reported.
No trials were identified.
AUTHORS' CONCLUSIONS: No randomised or quasi-randomised trials that evaluated the effect of surfactant in PH were identified. Therefore, no conclusions from such trials can be drawn. In view of the promising results from studies with less strict study designs than a randomised controlled trial, there is reason to conduct further trials of surfactant for the treatment of PH in neonates.
在20世纪60年代和70年代，肺出血（PH）主要发生在患有基础疾病的足月儿中，活产儿发病率为每1000例中有1.3例。PH的危险因素包括疾病严重程度、宫内生长受限、动脉导管未闭（PDA）、凝血功能障碍以及辅助通气需求。目前，PH发生在3%至5%的患有严重呼吸窘迫综合征（RDS）的早产通气婴儿中，这些婴儿通常患有PDA并接受过表面活性剂治疗。PH的病因被认为是由于肺内压迅速降低，这促进了通过PDA的左向右分流以及肺血流量增加。回顾性病例报告和一项前瞻性非对照研究显示表面活性剂在治疗PH方面取得了有前景的结果。
评估与安慰剂或不干预相比，表面活性剂治疗对患有PH的新生儿死亡率和发病率的影响。
为进行此次更新，于2012年2月8日检索了Cochrane图书馆2012年第2期；MEDLINE；EMBASE；CINAHL；Clinicaltrials.gov；Controlled-trials.com；儿科学术协会年会（摘要2视图）2000年至2011年的会议记录以及科学网。
评估表面活性剂对气管插管的足月儿或早产儿（<37周）PH治疗效果的随机或半随机对照试验。纳入的婴儿为月经后年龄达44周。所研究的干预措施为气管内滴注表面活性剂（天然或合成，无论剂量）与安慰剂或不干预。
如果通过文献检索确定了研究，计划分析包括风险比、风险差异、二分结局的受益或伤害所需治疗人数，以及连续结局的均值差异及其95%置信区间。将使用固定效应模型进行荟萃分析。将评估纳入试验的偏倚风险。将进行异质性检验，包括I统计量，以评估合并数据的适宜性并报告结果。
未发现相关试验。
未发现评估表面活性剂对PH治疗效果的随机或半随机试验。因此，无法得出此类试验的结论。鉴于比随机对照试验设计不太严格的研究取得了有前景的结果，有理由进一步开展表面活性剂治疗新生儿PH的试验。
