Department of Nephrology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Nephrology and Dialysis Unit, ASL CN1, Cuneo, Italy.
Blood Purif. 2022;51(11):943-952. doi: 10.1159/000522038. Epub 2022 Mar 1.
Impact assessment of new technologies in chronic hemodialysis (HD) is challenging due to HD patient frailty, the complexity of HD clinical trials and practice variability among countries. Among the most recent HD innovations, medium cut-off (MCO) dialyzers present an optimized membrane geometry that provides enhanced clearances for middle and large molecular weight uremic toxins (UT). These toxins are poorly cleared by available HD techniques and largely contribute to patient morbidity and mortality. The aim of this paper is to assess the available clinical evidence about MCO membranes and to identify the next steps needed to generate conclusive data on their use in HD.
With this purpose, we first reviewed and compared the current HD technologies aimed to improve the clearance of middle and large UT; subsequently, we used a Delphi questionnaire to identify and discuss the consensus about MCO efficacy within a large sample of the Italian Nephrology community.
Our investigation gathered a significant degree of consensus on the beneficial role of MCO membrane and expanded HD. Finally, we used our results to propose future trial designs and clinical investigations aimed to improve evidence quality about the use of these membranes in the present clinical scenario of dialysis units.
由于慢性血液透析(HD)患者身体虚弱、HD 临床试验复杂以及各国之间的实践差异,新技术对 HD 的影响评估具有挑战性。在最近的 HD 创新中,中分子截留(MCO)透析器具有优化的膜几何形状,可为中大分子尿毒症毒素(UT)提供更好的清除率。这些毒素不能被现有的 HD 技术有效清除,是导致患者发病率和死亡率高的主要原因。本文旨在评估 MCO 膜的现有临床证据,并确定下一步需要采取哪些措施来生成关于其在 HD 中应用的明确数据。
为此,我们首先回顾和比较了目前旨在提高中大分子 UT 清除率的 HD 技术;随后,我们使用 Delphi 问卷在意大利肾脏病学社区的大量样本中确定并讨论了对 MCO 疗效的共识。
我们的研究在 MCO 膜和扩展 HD 的有益作用方面达成了很高的共识。最后,我们利用研究结果提出了未来的试验设计和临床研究,旨在提高这些膜在当前透析单位临床环境下使用的证据质量。