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.
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引用次数: 0
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%, P = 0.022). Myoglobin pre-dialysis levels were not significantly different [160 (118-199) vs 167 (167-240) µg/L, P = .08].Median pre-dialysis levels of interleukin-6 [0.8 (0-4.4) vs 1.7 (0.2-7.2) pg/mL, P = .032], asymmetric dimethylarginine (ADMA) [163 (122-260) vs 167 (133-270) ng/mL, P = .01), mean pre-dialysis serum soluble tumor necrosis factor receptor 1 (sTNFR1) levels (12.7 ± 3.5 vs 13.6 ± 3.6 ng/mL, P = .039) and mean post-dialysis oxidized low-density lipoprotein levels (54 ± 18 vs 63 ± 22 ng/mL, P = .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) %, P = .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.
背景：中切断血液透析（MCO-HD）可改善中间分子（MM）尿毒症毒素的去除。新型超高通量维生素e包被（SHFVE）透析器对MM去除和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包括36名患者，随机分配接受3个月的MCO-HD治疗和3个月的SHFVE-HD治疗，反之亦然。主要终点是3个月后β -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提供的β -微球蛋白RR为74.2%[95%可信区间（CI） 71；[77] vs . 73.3% (95% CI 71；76)，差异为0.9% (95% CI -1.9%；3.6)}，泌乳素、α 1微球蛋白、血管内皮生长因子、游离轻链kappa和lambda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 vs 60.2±6.6%,P = 0.022）。透析前肌红蛋白水平无显著差异[160 (118-199)vs 167（167-240）µg/L, P = .08]。SHFVE-HD患者透析前平均白介素-6水平[0.8 (0-4.4)vs 1.7 (0.2-7.2) pg/mL, P = 0.032]、不对称二甲基精氨酸（ADMA） [163 （122-260) vs 167 (133-270) ng/mL, P = 0.01）、透析前平均血清可溶性肿瘤坏死因子受体1 （sTNFR1）水平（12.7±3.5 vs 13.6±3.6 ng/mL, P = 0.039）和透析后平均氧化低密度脂蛋白水平（54±18 vs 63±22 ng/mL, P = 0.01）显著降低。SHFVE-HD在透析开始后15分钟诱导血液白细胞计数的中位相对变异显著降低[-3.5(-6.8至1.6)vs -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。结论：与MCO-HD相比，SHFVE-HD似乎提供了相似的MM RR，并可能与改善的生物相容性参数有关。临床试验注册：NCT05610683。数据存放在普瓦捷临床研究中心。
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Clinical Kidney Journal: Clinical and Translational Nephrology (ckj), an official journal of the ERA-EDTA (European Renal Association-European Dialysis and Transplant Association), is a fully open access, online only journal publishing bimonthly. The journal is an essential educational and training resource integrating clinical, translational and educational research into clinical practice. ckj aims to contribute to a translational research culture among nephrologists and kidney pathologists that helps close the gap between basic researchers and practicing clinicians and promote sorely needed innovation in the Nephrology field. All research articles in this journal have undergone peer review.
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