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在线血液透析滤过(OL-HDF)与高通量透析相比的死亡率和心血管事件:来自土耳其 OL-HDF 研究的结果。

Mortality and cardiovascular events in online haemodiafiltration (OL-HDF) compared with high-flux dialysis: results from the Turkish OL-HDF Study.

机构信息

Division of Nephrology, Ege University School of Medicine, Izmir, Turkey.

出版信息

Nephrol Dial Transplant. 2013 Jan;28(1):192-202. doi: 10.1093/ndt/gfs407. Epub 2012 Dec 9.

Abstract

BACKGROUND

Online haemodiafiltration (OL-HDF) is considered to confer clinical benefits over haemodialysis (HD) in terms of solute removal in patients undergoing maintenance HD. The aim of this study was to compare postdilution OL-HDF and high-flux HD in terms of morbidity and mortality.

METHODS

In this prospective, randomized, controlled trial, we enrolled 782 patients undergoing thrice-weekly HD and randomly assigned them in a 1:1 ratio to either postdilution OL-HDF or high-flux HD. The mean age of patients was 56.5 ± 13.9 years, time on HD 57.9 ± 44.6 months with a diabetes incidence of 34.7%. The follow-up period was 2 years, with the mean follow-up of 22.7 ± 10.9 months. The primary outcome was a composite of death from any cause and nonfatal cardiovascular events. The major secondary outcomes were cardiovascular and overall mortality, intradialytic complications, hospitalization rate, changes in several laboratory parameters and medications used.

RESULTS

The filtration volume in OL-HDF was 17.2 ± 1.3 L. Primary outcome was not different between the groups (event-free survival of 77.6% in OL-HDF versus 74.8% in the high-flux group, P = 0.28), as well as cardiovascular and overall survival, hospitalization rate and number of hypotensive episodes. In a post hoc analysis, the subgroup of OL-HDF patients treated with a median substitution volume >17.4 L per session (high-efficiency OL-HDF, n = 195) had better cardiovascular (P = 0.002) and overall survival (P = 0.03) compared with the high-flux HD group. In adjusted Cox-regression analysis, treatment with high-efficiency OL-HDF was associated with a 46% risk reduction for overall mortality {RR = 0.54 [95% confidence interval (95% CI) 0.31-0.93], P = 0.02} and a 71% risk reduction for cardiovascular mortality [RR = 0.29 (95% CI 0.12-0.65), P = 0.003] compared with high-flux HD.

CONCLUSIONS

The composite of all-cause mortality and nonfatal cardiovascular event rate was not different in the OL-HDF and in the high-flux HD groups. In a post hoc analysis, OL-HDF treatment with substitution volumes over 17.4 L was associated with better cardiovascular and overall survival.

摘要

背景

在线血液透析滤过(OL-HDF)被认为在溶质清除方面优于血液透析(HD),可改善维持性 HD 患者的临床预后。本研究旨在比较后稀释 OL-HDF 与高通量 HD 在发病率和死亡率方面的差异。

方法

这是一项前瞻性、随机、对照临床试验,纳入了 782 名每周接受 3 次 HD 的患者,并将其随机以 1:1 的比例分配至后稀释 OL-HDF 或高通量 HD 组。患者的平均年龄为 56.5±13.9 岁,HD 时间为 57.9±44.6 个月,糖尿病发病率为 34.7%。随访时间为 2 年,平均随访时间为 22.7±10.9 个月。主要终点为全因死亡和非致死性心血管事件的复合终点。主要次要终点为心血管和总死亡率、透析中并发症、住院率、实验室参数和用药变化。

结果

OL-HDF 的超滤量为 17.2±1.3 L。两组间主要终点无差异(OL-HDF 组无事件生存率为 77.6%,高通量组为 74.8%,P=0.28),心血管和总生存率、住院率和低血压发作次数也无差异。在事后分析中,OL-HDF 组中接受中位置换液量>17.4 L/次的患者(高效 OL-HDF,n=195)的心血管(P=0.002)和总体生存(P=0.03)情况优于高通量 HD 组。在调整后的 Cox 回归分析中,与高通量 HD 相比,高效 OL-HDF 治疗与全因死亡率降低 46%相关[RR=0.54(95%CI 0.31-0.93),P=0.02]和心血管死亡率降低 71%相关[RR=0.29(95%CI 0.12-0.65),P=0.003]。

结论

OL-HDF 组和高通量 HD 组的全因死亡率和非致死性心血管事件发生率无差异。在事后分析中,置换液量超过 17.4 L 的 OL-HDF 治疗与更好的心血管和总体生存相关。

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