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pHA130血液吸附联合血液透析与在线血液透析滤过清除蛋白结合及中分子量尿毒症毒素的疗效比较:一项随机对照试验

Comparative Efficacy of pHA130 Haemoadsorption Combined with Haemodialysis Versus Online Haemodiafiltration in Removing Protein-Bound and Middle-Molecular-Weight Uraemic Toxins: A Randomized Controlled Trial.

作者信息

Yu Shaobin, Yuan Huaihong, Xiong Xiaohong, Zhu Yalin, Fu Ping

机构信息

Department of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu 610041, China.

出版信息

Toxins (Basel). 2025 Aug 5;17(8):392. doi: 10.3390/toxins17080392.

DOI:10.3390/toxins17080392
PMID:40864068
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12390373/
Abstract

Protein-bound uraemic toxins (PBUTs), such as indoxyl sulphate (IS) and p-cresyl sulphate (PCS), are poorly cleared by conventional haemodialysis (HD) or haemodiafiltration (HDF). Haemoadsorption combined with HD (HAHD) using the novel pHA130 cartridge may increase PBUT removal, and this trial aimed to compare its efficacy and safety with HDF in patients with end-stage renal disease (ESRD). In this single-centre, open-label trial, 30 maintenance HD patients were randomized (1:1:1) to HDF once every two weeks (HDF-q2w), HAHD once every two weeks (HAHD-q2w), or HAHD once weekly (HAHD-q1w) for 8 weeks, with the primary endpoint being the single-session reduction ratio (RR) of IS. The combined HAHD group (n = 20) demonstrated a significantly greater IS reduction than the HDF-q2w group (n = 10) (46.9% vs. 31.8%; = 0.044) and superior PCS clearance (44.6% vs. 31.4%; = 0.003). Both HAHD regimens significantly reduced predialysis IS levels at Week 8. Compared with HDF, weekly HAHD provided greater relief from pruritus and improved sleep quality, with comparable adverse events among groups. In conclusion, HAHD with the pHA130 cartridge is more effective than HDF for enhancing single-session PBUT removal and alleviating uraemic symptoms in patients with ESRD, with weekly application showing optimal symptomatic benefits.

摘要

蛋白结合型尿毒症毒素(PBUTs),如硫酸吲哚酚(IS)和对甲酚硫酸盐(PCS),通过传统血液透析(HD)或血液透析滤过(HDF)难以清除。使用新型pHA130滤器的血液吸附联合HD(HAHD)可能会增加PBUT的清除,本试验旨在比较其与HDF在终末期肾病(ESRD)患者中的疗效和安全性。在这项单中心、开放标签试验中,30例维持性HD患者被随机分为三组(1:1:1),分别接受每两周一次的HDF(HDF-q2w)、每两周一次的HAHD(HAHD-q2w)或每周一次的HAHD(HAHD-q1w),为期8周,主要终点是IS的单次治疗降低率(RR)。联合HAHD组(n = 20)的IS降低幅度显著大于HDF-q2w组(n = 10)(46.9%对31.8%;P = 0.044),PCS清除率更高(44.6%对31.4%;P = 0.003)。两种HAHD方案在第8周时均显著降低了透析前IS水平。与HDF相比,每周一次的HAHD能更有效地缓解瘙痒并改善睡眠质量,各组不良事件发生率相当。总之,使用pHA130滤器的HAHD在增强ESRD患者单次治疗PBUT清除和缓解尿毒症症状方面比HDF更有效,每周应用显示出最佳的症状改善效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0b1/12390373/f033b41826c8/toxins-17-00392-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0b1/12390373/f033b41826c8/toxins-17-00392-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0b1/12390373/f033b41826c8/toxins-17-00392-g001.jpg

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本文引用的文献

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From Physicochemical Classification to Multidimensional Insights: A Comprehensive Review of Uremic Toxin Research.从物理化学分类到多维洞察:尿毒症毒素研究综述
Toxins (Basel). 2025 Jun 10;17(6):295. doi: 10.3390/toxins17060295.
2
Long-Term Safety of "4-Hour" Hemoadsorption Combined with Hemodialysis in Maintenance Hemodialysis Patients: A Multicenter Prospective Cohort Study.“4小时”血液吸附联合血液透析在维持性血液透析患者中的长期安全性:一项多中心前瞻性队列研究
Blood Purif. 2025;54(7):413-423. doi: 10.1159/000545988. Epub 2025 Apr 21.
3
Efficacy of HA130 Hemoadsorption in Removing Advanced Glycation End Products in Maintenance Hemodialysis Patients.
HA130血液吸附对维持性血液透析患者清除晚期糖基化终末产物的疗效
Artif Organs. 2025 May;49(5):900-906. doi: 10.1111/aor.14954. Epub 2025 Jan 21.
4
Hemoadsorption: consensus report of the 30th Acute Disease Quality Initiative workgroup.血液吸附:第 30 届急性疾病质量倡议工作组的共识报告。
Nephrol Dial Transplant. 2024 Nov 27;39(12):1945-1964. doi: 10.1093/ndt/gfae089.
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Extracorporeal Techniques in Kidney Failure.肾衰竭的体外技术。
Blood Purif. 2024;53(5):343-357. doi: 10.1159/000533258. Epub 2023 Sep 12.
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Combined Hemoperfusion-Hemodialysis in End-Stage Renal Disease Patients.终末期肾病患者的血液灌流-血液透析联合治疗。
Contrib Nephrol. 2023;200:118-122. doi: 10.1159/000527953. Epub 2023 Jun 1.
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Expanding the potential therapeutic options of hemoperfusion in the era of improved sorbent biocompatibility.在吸附剂生物相容性改善的时代拓展血液灌流的潜在治疗选择。
Kidney Res Clin Pract. 2023 May;42(3):298-311. doi: 10.23876/j.krcp.22.223. Epub 2023 Mar 29.
8
The Effect of Combination Use of Hemodialysis and Hemoperfusion on Microinflammation in Elderly Patients with Maintenance Hemodialysis.血液透析与血液灌流联合应用对老年维持性血液透析患者微炎症状态的影响。
Blood Purif. 2022;51(9):739-746. doi: 10.1159/000518857. Epub 2022 Jan 14.
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Randomized Control Study on Hemoperfusion Combined with Hemodialysis versus Standard Hemodialysis: Effects on Middle-Molecular-Weight Toxins and Uremic Pruritus.血液灌流联合血液透析与标准血液透析的随机对照研究:对中分子毒素和尿毒症瘙痒的影响
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Effect of different hemodialysis modalities on hepcidin clearance in patients undergoing maintenance hemodialysis.不同血液透析方式对维持性血液透析患者铁调素清除的影响。
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