超高通量维生素E涂层和中截留量透析器对尿毒症毒素清除及生物相容性的影响：E-FLUX随机对照研究

Effects of super high-flux vitamin E-coated and medium cut-off dialyzers on uremic toxins removal and biocompatibility: the E-FLUX randomized controlled study.

作者信息

Belmouaz Mohamed, Cogne Etienne, Joly Florent, Duthe Fabien, Desport Estelle, Martin Cecile, Hauet Thierry, Giraud Sebastien, Lemarie Estelle, Durocher Lisa, Bridoux Frank

机构信息

Department of Nephrology, Poitiers University Hospital, Poitiers, France.

Department of Pharmacology, Poitiers University Hospital, Poitiers, France.

出版信息

Clin Kidney J. 2025 Apr 11;18(5):sfaf106. doi: 10.1093/ckj/sfaf106. eCollection 2025 May.

DOI:10.1093/ckj/sfaf106

PMID:40342620

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12059640/

Abstract

BACKGROUND

Medium cut-off hemodialysis (MCO-HD) improves removal of middle molecules (MM) uremic toxins. The effects of the novel super high-flux vitamin E-coated (SHFVE) dialyzer on MM removal and biocompatibility parameters including inflammation and oxidative stress remain to be investigated.

METHODS

This non-inferiority cross-over prospective randomized study included 36 patients randomly assigned to receive either 3 months of MCO-HD followed by 3 months of SHFVE-HD, or vice versa. The primary endpoint was beta2-microglobulin reduction ratio (RR) after 3 months. Secondary endpoints were other MM RR and biocompatibility parameters.

RESULTS

SHFVE-HD provided non-inferior beta2-microglobulin RR as compared with MCO-HD {74.2% [95% confidence interval (CI) 71; 77] vs 73.3% (95% CI 71; 76) with a difference of 0.9% (95% CI -1.9%; 3.6), respectively}, with similar mean RR of prolactin, alpha1-microglobulin, vascular endothelial growth factor, and kappa and lambda free light chains. SHFVE-HD induced lower mean myoglobin RR compared with MCO-HD (55.5 ± 7.3 vs 60.2 ± 6.6%, = 0.022). Myoglobin pre-dialysis levels were not significantly different [160 (118-199) vs 167 (167-240) µg/L, = .08].Median pre-dialysis levels of interleukin-6 [0.8 (0-4.4) vs 1.7 (0.2-7.2) pg/mL, = .032], asymmetric dimethylarginine (ADMA) [163 (122-260) vs 167 (133-270) ng/mL, = .01), mean pre-dialysis serum soluble tumor necrosis factor receptor 1 (sTNFR1) levels (12.7 ± 3.5 vs 13.6 ± 3.6 ng/mL, = .039) and mean post-dialysis oxidized low-density lipoprotein levels (54 ± 18 vs 63 ± 22 ng/mL, = .01) decreased significantly with SHFVE-HD. SHFVE-HD induced a significantly lower median relative variation in blood leucocyte count 15 min after dialysis initiation [-3.5 (-6.8 to 1.6) vs -6.2 (-12.9 to -1.5) %, = .009], encompassing both polymorphonuclear neutrophils and monocytes.

CONCLUSION

Compared with MCO-HD, SHFVE-HD appears to provide similar MM RR and may be associated with improved biocompatibility parameters.

TRIAL REGISTRATION CLINICALTRIALSGOV

NCT05610683. Data deposited at Centre de la recherche clinique CHU Poitiers.

摘要

背景

中截留量血液透析（MCO-HD）可改善中分子（MM）尿毒症毒素的清除。新型超高通量维生素E涂层（SHFVE）透析器对MM清除及包括炎症和氧化应激在内的生物相容性参数的影响仍有待研究。

方法

这项非劣效性交叉前瞻性随机研究纳入36例患者，随机分配接受3个月的MCO-HD，随后接受3个月的SHFVE-HD，或反之。主要终点是3个月后的β2-微球蛋白降低率（RR）。次要终点是其他MM RR和生物相容性参数。

结果

与MCO-HD相比，SHFVE-HD的β2-微球蛋白RR不劣（分别为74.2%[95%置信区间（CI）71；77]和73.3%（95%CI 71；76），差异为0.9%（95%CI -1.9%；3.6%）），催乳素、α1-微球蛋白、血管内皮生长因子以及κ和λ游离轻链的平均RR相似。与MCO-HD相比，SHFVE-HD诱导的平均肌红蛋白RR较低（55.5±7.3对60.2±6.6%，P = 0.022）。透析前肌红蛋白水平无显著差异[160（118-199）对167（167-240）μg/L，P = 0.08]。透析前白细胞介素-6的中位数水平[0.8（0-4.4）对1.7（0.2-7.2）pg/mL，P = 0.032]、不对称二甲基精氨酸（ADMA）[163（122-260）对167（133-270）ng/mL，P = 0.01]、透析前血清可溶性肿瘤坏死因子受体1（sTNFR1）的平均水平（12.7±3.5对13.6±3.6 ng/mL，P = 0.039）以及透析后氧化型低密度脂蛋白的平均水平（54±18对63±22 ng/mL，P = 0.01）在SHFVE-HD时显著降低。SHFVE-HD在透析开始后15分钟诱导的血液白细胞计数中位数相对变化显著更低[-3.5（-6.8至1.6）对-6.2（-12.9至-1.5）%，P = 0.009]，包括多形核中性粒细胞和单核细胞。