Catapano Gerardo, Morrone Giuseppe, Hu Lilio, Fragomeni Gionata, Buscaroli Andrea
Department of Mechanical, Energy and Management Engineering, University of Calabria, via P. Bucci, 87030 Rende, Italy.
Department of Medical and Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, 40138 Bologna, Italy.
Membranes (Basel). 2025 Feb 5;15(2):51. doi: 10.3390/membranes15020051.
Poor water treatments and concentrates to prepare dialysis fluids favor bacterial growth-producing pyrogens (e.g., endotoxins) that may cross hemodialysis, particularly high-flux, membranes. This puts hemodialysis patients at risk of acute bacteremia, pyrogenic reactions, long-term complications, loss of residual renal function, and poor nutritional status. Consequently, regulatory bodies worldwide recommend using ultrapure dialysis fluid for routine hemodialysis. Requests are also growing for the online production of sterile non-pyrogenic substitution fluid from ultrapure dialysis fluid. This way, large volumes of infusion solution may be safely and economically produced, enabling more end-stage kidney disease patients to benefit from the greater capacity of hemodiafiltration to remove toxins than purely diffusive hemodialysis treatment. Ultrapure dialysis and substitution fluids are often produced upstream from hemodialyzers by online filtration of standard dialysis fluid through cascades of bacteria- and endotoxin-retentive filters (ETRFs). Commercial ETRFs differ for membranes, operation, performance, duration and maintenance protocols, connection to a dialysis machine, disinfection procedures, and replacement schedule. Although suboptimal ETRF choice may increase treatment costs, the difficulty in gathering comparative information on commercial ETRFs complicates their selection. To aid dialysis centers in selecting the most convenient and suitable ETRF for their needs, herein, relevant characteristics of commercial ETRFs are reported and critically reviewed for a quick yet effective comparison.
用于制备透析液的水处理不当和浓缩液有利于细菌生长，产生热原（如内毒素），这些热原可能会透过血液透析膜，尤其是高通量膜。这使血液透析患者面临急性菌血症、热原反应、长期并发症、残余肾功能丧失和营养状况不佳的风险。因此，全球监管机构建议在常规血液透析中使用超纯透析液。对从超纯透析液在线生产无菌无热原替代液的需求也在增加。通过这种方式，可以安全、经济地生产大量输液溶液，使更多终末期肾病患者能够受益于血液透析滤过比单纯扩散性血液透析治疗更强的毒素清除能力。超纯透析液和替代液通常在血液透析器的上游生产，通过一系列细菌和内毒素保留过滤器（ETRF）对标准透析液进行在线过滤。商业ETRF在膜、操作、性能、使用期限和维护方案、与透析机的连接、消毒程序以及更换时间表等方面存在差异。尽管选择次优的ETRF可能会增加治疗成本，但收集商业ETRF的比较信息存在困难，这使得它们的选择变得复杂。为了帮助透析中心选择最方便、最适合其需求的ETRF，本文报告并严格审查了商业ETRF的相关特性，以便进行快速而有效的比较。
