复用中通量透析器对尿毒症毒素和细胞因子清除的比较疗效：一项随机对照试验。

Comparative Efficacy of Reused Medium Cut-Off Dialyzers on Uremic Toxin and Cytokine Clearance: A Randomized Controlled Trial.

作者信息

Lukkanalikitkul Eakalak, Jirayuphat Nichnan, Anutrakulchai Sirirat

机构信息

Center of Excellence in Kidney Diseases, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.

Division of Nephrology, Department of Internal Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.

出版信息

Life (Basel). 2025 Sep 18;15(9):1468. doi: 10.3390/life15091468.

DOI:10.3390/life15091468

PMID:41010409

Abstract

INTRODUCTION

Expanded hemodialysis using medium cut-off (MCO) dialyzers effectively removes middle-molecule uremic toxins, comparable to hemodiafiltration, but their single-use designation increases the dialysis costs. This study evaluated the efficacy and safety of reusing two MCO dialyzers available in Thailand.

METHODS

In this randomized controlled trial, hemodialysis patients were assigned to receive treatment with either Theranova 500 or Elisio 21HX dialyzers. Each dialyzer was reprocessed using peracetic acid and reused for up to 15 sessions. Dialyzer performance was assessed by the reduction ratios (RRs) of solutes, including β2-microglobulin (β2-MG), kappa and lambda free light chains (κ-FLC, λ-FLC), and interleukin-6 (IL-6), at baseline and the 2nd, 5th, 10th, and 15th sessions.

RESULTS

Forty-eight patients were enrolled (mean age 63.6 ± 13.7 years; 62.5% male) and randomized into 2 groups with comparable baseline characteristics. RRs for β2-MG, κ-FLC, and λ-FLC were similar between the groups and declined modestly over time after dialyzer reused (β2-MG: 78.2% to 72.5% vs. 77.2% to 74.5%, κ-FLC: 64.6% to 51.3% vs. 58.9% to 49.5%, and λ-FLC: 51.2% to 46.4% vs. 49.4% to 39.2% in the Theranova 500 and Elisio 21HX groups, respectively). Theranova 500 demonstrated significantly higher IL-6 clearance in the 2nd (29.9% vs. 16.0%; = 0.018) and 5th (23.8% vs. 7.7%, = 0.031) sessions. It also showed a non-significant trend toward lower dialyzer survival (HR 3.98; = 0.085) and higher, though clinically acceptable, albumin loss (mean difference 0.56 g/session; < 0.001), which decreased with reuse.

CONCLUSIONS

Both MCO dialyzers demonstrated comparable overall performance during reuse. Theranova 500 provided better IL-6 clearance with manageable albumin loss. Implementation of high-quality dialyzer reuse protocols may optimize clinical efficacy and patient outcomes while balancing cost, accessibility, and environmental considerations.

摘要

引言

使用中截留量（MCO）透析器进行的扩展血液透析可有效清除中分子尿毒症毒素，其效果与血液透析滤过相当，但因其一次性使用的特性增加了透析成本。本研究评估了泰国现有的两种MCO透析器重复使用的有效性和安全性。

方法

在这项随机对照试验中，血液透析患者被分配接受使用Theranova 500或Elisio 21HX透析器进行治疗。每个透析器使用过氧乙酸进行再处理，并重复使用多达15次。在基线以及第2、5、10和15次透析时，通过溶质清除率（RRs）评估透析器性能，溶质包括β2-微球蛋白（β2-MG）、κ和λ游离轻链（κ-FLC、λ-FLC）以及白细胞介素-6（IL-6）。

结果

48名患者入组（平均年龄63.6±13.7岁；62.5%为男性），并随机分为两组，两组基线特征相当。两组间β2-MG、κ-FLC和λ-FLC的清除率相似，且在透析器重复使用后随时间略有下降（Theranova 500组β2-MG：从78.2%降至72.5%，而Elisio 21HX组从77.2%降至74.5%；κ-FLC：分别从64.6%降至51.3%和从58.9%降至49.5%；λ-FLC：分别从51.2%降至46.4%和从49.4%降至39.2%）。Theranova 500在第（29.9%对16.0%；P = 0.018）和第5次（23.8%对7.7%，P = 0.031）透析时显示出显著更高的IL-6清除率。它还显示出透析器存活时间缩短的非显著趋势（风险比3.98；P = 0.085）以及白蛋白损失更高（尽管在临床可接受范围内）（平均差异0.56 g/次；P < 0.001），且随着重复使用而降低。