Noori Shahab, Seri Istvan
Division of Neonatology and the Center for Fetal and Neonatal Medicine, Department of Pediatrics, Children's Hospital Los Angeles and the LAC+USC Medical Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Sidra Medical and Research Center, Doha, Qatar.
Semin Fetal Neonatal Med. 2015 Aug;20(4):238-45. doi: 10.1016/j.siny.2015.03.005. Epub 2015 Mar 29.
With the advances in biomedical research and neonatal intensive care, our understanding of cardiovascular developmental physiology and pathophysiology has significantly improved during the last few decades. Despite this progress, the current management of circulatory compromise depends primarily on experts' opinions rather than high level of evidence. The lack of reliable, accurate, continuous and preferably non-invasive monitoring techniques has further limited our ability to collect the information needed for the design and execution of more sophisticated clinical trials with a better chance to provide the evidence we need. Given the lack of randomized, placebo-controlled trials investigating clinically relevant outcomes of novel treatments of neonatal cardiovascular compromise, we must now use the available lower level of evidence and our present understanding of developmental physiology and pathophysiology when providing cardiovascular supportive care to critically ill neonates. However, with recent advances in cardiovascular monitoring capabilities, direct and more objective assessment of the changes in cardiovascular function, organ blood flow, and tissue oxygenation have become possible. These advances have helped in our clinical assessment and enabled us to start designing more sophisticated interventional clinical trials using clinically relevant endpoints.
随着生物医学研究和新生儿重症监护技术的进步,在过去几十年里,我们对心血管发育生理学和病理生理学的理解有了显著提高。尽管取得了这一进展,但目前对循环功能不全的管理主要依赖专家意见,而非高水平的证据。缺乏可靠、准确、连续且最好是非侵入性的监测技术,进一步限制了我们收集设计和开展更复杂临床试验所需信息的能力,而这类试验更有可能提供我们所需的证据。鉴于缺乏针对新生儿心血管功能不全新疗法临床相关结局的随机、安慰剂对照试验,在为危重新生儿提供心血管支持治疗时,我们现在必须利用现有的较低水平证据以及我们目前对发育生理学和病理生理学的理解。然而,随着心血管监测能力的最新进展,对心血管功能、器官血流和组织氧合变化进行直接且更客观的评估已成为可能。这些进展有助于我们进行临床评估,并使我们能够开始使用临床相关终点设计更复杂的介入性临床试验。