新型含氟聚氨基甲酸酯表面修饰大分子透析器在终末期肾病患者中的安全性。

Safety of a Novel Dialyzer Containing a Fluorinated Polyurethane Surface-Modifying Macromolecule in Patients with End-Stage Kidney Disease.

机构信息

California Institute of Renal Research, Chula Vista, California, USA.

California Institute of Renal Research, San Diego, California, USA.

出版信息

Blood Purif. 2021;50(6):959-967. doi: 10.1159/000514937. Epub 2021 Mar 31.

DOI:10.1159/000514937

PMID:33789265

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8491509/

Abstract

BACKGROUND

By inhibiting the adsorption of protein and platelets, surface-modifying macromolecules (SMMs) may improve the hemocompatibility of hemodialyzers. This trial aims to assess the performance and safety of a novel dialyzer with a fluorinated polyurethane SMM, Endexo™.

METHODS

This prospective, sequential, multicenter, open-label study (NCT03536663) was designed to meet regulatory requirements for clinical testing of new hemodialyzers, including assessment of the in vivo ultrafiltration coefficient (Kuf). Adults prescribed thrice-weekly hemodialysis were eligible for enrollment. After completing 12 hemodialysis sessions with an Optiflux® F160NR dialyzer, patients received 38 sessions with the dialyzer with Endexo. Evaluated parameters included the in vivo Kuf of the dialyzer with Endexo extent of removal of urea, albumin, and β2-microglobulin (β2M), as well as complement activation.

RESULTS

Twenty-three patients received 268 hemodialysis treatments during the Optiflux period, and 18 patients received 664 hemodialysis treatments during the Endexo period. Three serious adverse events were reported, and none of them were considered device related. No overt complement activation was observed with either dialyzer. Both dialyzers were associated with comparable mean increases in serum albumin levels from pre- to posthemodialysis (Optiflux: 7.9%; Endexo: 8.0%). These increases can be viewed in the context of a mean increase in hemoglobin of approximately 5% and a mean ultrafiltration volume removed of approximately 2.2 L. The corrected mean β2M removal rate was 47% higher during the Endexo period (67.73%). Mean treatment times (208 vs. 205 min), blood flow rates (447.7 vs. 447.5 mL/min), dialysate flow rates (698.5 vs. 698.0 mL/min), urea reduction ratio (82 vs. 81%), and spKt/V (2.1 vs. 1.9) were comparable for the Endexo and Optiflux periods, respectively. The mean (SD) Kuf was 15.85 (10.33) mL/h/mm Hg during the first use of the dialyzer with Endexo (primary endpoint) and 16.36 (9.92) mL/h/mm Hg across the Endexo period.

CONCLUSIONS

The safety of the novel dialyzer with Endexo was generally comparable to the Optiflux dialyzer, while exhibiting a higher β2M removal rate.

摘要

背景

通过抑制蛋白质和血小板的吸附，表面修饰的大分子（SMM）可以改善血液透析器的血液相容性。本试验旨在评估一种新型透析器的性能和安全性，该透析器具有氟代聚氨酯 SMM，Endexo™。

方法

这项前瞻性、序贯、多中心、开放标签研究（NCT03536663）旨在满足新血液透析器临床测试的监管要求，包括评估体内超滤系数（Kuf）。接受每周三次血液透析治疗的成年人有资格入组。在使用 Optiflux®F160NR 透析器完成 12 次血液透析后，患者接受了 38 次 Endexo 透析器的透析。评估的参数包括体内 Endexo 透析器的超滤系数、尿素、白蛋白和β2-微球蛋白（β2M）的清除率以及补体激活。

结果

23 名患者在 Optiflux 期间接受了 268 次血液透析治疗，18 名患者在 Endexo 期间接受了 664 次血液透析治疗。报告了 3 例严重不良事件，均与器械无关。两种透析器均未观察到明显的补体激活。两种透析器均与血液透析前后血清白蛋白水平的平均升高相关（Optiflux：7.9%；Endexo：8.0%）。在血红蛋白平均升高约 5%和平均超滤量去除约 2.2L 的情况下可以看到这些升高。Endexo 期间校正的平均β2M 清除率提高了 47%（67.73%）。平均治疗时间（208 分钟与 205 分钟）、血流速度（447.7 毫升/分钟与 447.5 毫升/分钟）、透析液流速（698.5 毫升/分钟与 698.0 毫升/分钟）、尿素清除率（82%与 81%）和 spKt/V（2.1 与 1.9）在 Endexo 和 Optiflux 期间分别相当。首次使用 Endexo 透析器时的平均（SD）Kuf 为 15.85（10.33）mL/h/mm Hg（主要终点），Endexo 期间的平均 Kuf 为 16.36（9.92）mL/h/mm Hg。