NPEU Clinical Trials Unit, National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Department of Paediatrics and Neonatology, University Hospital of North Tees, Stockton-on-Tees, UK; Durham University, Stockton-on-Tees, UK.
Semin Fetal Neonatal Med. 2018 Aug;23(4):267-272. doi: 10.1016/j.siny.2018.03.004. Epub 2018 Mar 7.
Despite several decades of research into treatments for patent ductus arteriosus (PDA), there is continued uncertainty regarding whether, when, and how best to treat PDA and the long-term consequences. There are almost 5000 babies enrolled into clinical trials, but the questions remain largely unanswered. Many of the trials performed over the period were well designed and addressed important clinical questions, but the results are not necessarily directly applicable to the clinical management dilemmas of today since perinatal care has improved over time per se, the patient population is typically more premature, and there have been technological advances in diagnosis. This article examines some of the approaches taken, how trial designs evolved over time, especially in terms of the patient population and outcomes evaluated, and it offers points to consider when planning future research.
尽管已经对动脉导管未闭（PDA）的治疗方法进行了几十年的研究，但对于是否、何时以及如何最好地治疗 PDA 以及长期后果仍存在持续的不确定性。已经有将近 5000 名婴儿参与了临床试验，但这些问题仍然很大程度上没有得到回答。在此期间进行的许多试验设计良好，解决了重要的临床问题，但由于围产期护理本身随着时间的推移得到了改善，患者人群通常更早产，以及在诊断方面取得了技术进步，因此结果不一定直接适用于当今的临床管理难题。本文探讨了一些已采取的方法，以及试验设计随时间的演变，特别是在患者人群和评估的结果方面，并提供了在规划未来研究时需要考虑的要点。
