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

Randomized Control Study on Hemoperfusion Combined with Hemodialysis versus Standard Hemodialysis: Effects on Middle-Molecular-Weight Toxins and Uremic Pruritus.

作者信息

Zhao Delong, Wang Yuanda, Wang Yong, Jiang Aili, Cao Ning, He Yani, Wang Junxia, Guo Zhiyong, Liu Wenhu, Shi Wei, Hao Lirong, Li Jinyu, Li Wenge, Wang Caili, Wang Jianqin, Lin Hongli, Shi Wei, Wang Lihua, Jiang Hongli, Ding Guohua, Li Yun, Hu Wenbo, Yue Hua, Liu Jian, Yang Xiaoping, Yang Yibin, Liu Guohui, Li Hong, Xiao Yuefei, Wang Niansong, Jiang Gengru, Ma Guoying, Wang Jie, Li Ying, Li Rongshan, Li Qian, Sun Shiren, Jiao Jundong, Xi Chunsheng, Cai Guangyan, Sun Xuefeng, Chen Xiangmei

机构信息

Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing, China,

出版信息

Blood Purif. 2022 Aug 11:1-11. doi: 10.1159/000525225.

DOI:10.1159/000525225

PMID:35952629

Abstract

INTRODUCTION

Classic hemodialysis schedules present inadequate middle-molecular-weight toxin clearance due to limitations of membrane-based separation processes. Accumulation of uremic retention solutes may result in specific symptoms (e.g., pruritus) and may affect clinical outcome and patient's quality of life. Hemoperfusion (HP) is a blood purification modality based on adsorption that can overcome such limitations, and thus, it may be interesting to test the efficacy of at least one session per week of HP combined with hemodialysis. This is a randomized, open-label trial, controlled, multicenter clinical study to investigate the effect of long-term HP combined with hemodialysis on middle-molecular-weight toxins and uremic pruritus in maintenance hemodialysis (MHD) patients.

METHODS

438 MHD patients from 37 HD centers in China with end-stage kidney disease (63.9% males, mean age 51 years) suffering from chronic intractable pruritus were enrolled in the study. Eligible patients were randomized into four groups: low-flux hemodialysis (LFHD), high-flux hemodialysis (HFHD), HP + LFHD, and HP + HFHD at a 1:1:1:1 ratio. Beta-2 microglobulin (β2M) and parathyroid hormone (PTH) were measured at baseline, 3-6, and 12 months. At the same time points, the pruritus score was evaluated. The primary outcome was the reduction of β2M and PTH, while the secondary outcome was the reduction of the pruritus score.

RESULTS

In the two groups HP + LFHD and HP + HFHD, there was a significant decrease of β2M and PTH levels after 12 months compared to the control groups. No significant differences were noted between HP + LFHD and HP + HFHD. Pruritus score reduction was 63% in the HP + LFHD group and 51% in the HP + HFHD group, respectively.

CONCLUSION

The long-term HP + HD can reduce β2M and PTH levels and improve pruritus in MHD patients independently on the use of high- or low-flux dialyzers, showing that the results are linked to the effect of adsorption.

摘要

引言

由于基于膜的分离过程存在局限性，传统的血液透析方案对中分子量毒素的清除不足。尿毒症潴留溶质的蓄积可能导致特定症状（如瘙痒），并可能影响临床结局和患者的生活质量。血液灌流（HP）是一种基于吸附的血液净化方式，可克服此类局限性，因此，每周至少进行一次HP联合血液透析的疗效测试可能会很有意思。这是一项随机、开放标签、对照、多中心临床研究，旨在调查长期HP联合血液透析对维持性血液透析（MHD）患者中分子量毒素和尿毒症瘙痒的影响。

方法

来自中国37个血液透析中心的438例患有终末期肾病（男性占63.9%，平均年龄51岁）且患有慢性顽固性瘙痒的MHD患者被纳入研究。符合条件的患者按1:1:1:1的比例随机分为四组：低通量血液透析（LFHD）、高通量血液透析（HFHD）、HP+LFHD和HP+HFHD。在基线、3至6个月和12个月时测量β2微球蛋白（β2M）和甲状旁腺激素（PTH）。在相同时间点评估瘙痒评分。主要结局是β2M和PTH的降低，次要结局是瘙痒评分的降低。