Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA 94304-1510, USA.
J Perinatol. 2010 Apr;30(4):241-52. doi: 10.1038/jp.2010.3. Epub 2010 Feb 25.
Medical and surgical interventions are widely used to close a persistently patent ductus arteriosus in preterm infants. Objective evidence to support these practices is lacking, causing some to question their usage. Emerging evidence suggests that treatments that close the patent ductus may be detrimental. This review examines the history of and evidence underlying these treatments. Neither individual trials, pooled data from groups of randomized-controlled trials, nor critical examination of the immediate consequences of treatment provide evidence that medical or surgical closure of the ductus is beneficial in preterm infants. These conclusions are supported by sufficient evidence. Neither continued routine use of these treatments nor additional clinical trials using similar designs seems to be justified. A definitive trial, comparing current standard management with novel strategies not primarily intended to achieve ductal closure, may be necessary to resolve doubts regarding the quality or conduct of prior studies.
医疗和手术干预广泛用于关闭早产儿持续开放的动脉导管。缺乏支持这些做法的客观证据,这引起了一些人对其使用的质疑。新出现的证据表明,关闭动脉导管的治疗可能是有害的。本综述考察了这些治疗方法的历史和证据基础。无论是单独的试验、随机对照试验组的汇总数据,还是对治疗即时后果的批判性检查,都没有提供证据表明,在早产儿中,药物或手术关闭动脉导管是有益的。这些结论有充分的证据支持。继续常规使用这些治疗方法或使用类似设计的额外临床试验似乎都没有道理。可能需要进行一项确定性试验,将当前的标准治疗方法与并非主要旨在实现导管闭合的新策略进行比较,以消除对先前研究的质量或实施的疑虑。