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使用Physidia S系统进行每日短时血液透析的安全性和有效性:培训期间的临床性能评估

Safety and Efficacy of Short Daily Hemodialysis with Physidia S System: Clinical Performance Assessment during the Training Period.

作者信息

Fessi Hafedh, Szelag Jean-Christophe, Courivaud Cécile, Nicoud Philippe, Aguilera Didier, Gilbert Olivia, Morena Marion, Thomas Michel, Canaud Bernard, Cristol Jean-Paul

机构信息

Nephrology Department, Tenon Hospital, 75020 Paris, France.

Dialysis Department, Aural Dialysis Center, 69008 Lyon, France.

出版信息

J Clin Med. 2022 Apr 11;11(8):2123. doi: 10.3390/jcm11082123.

Abstract

BACKGROUND

A growing body of scientific evidence indicates that clinical outcomes of hemodialysis patients can be improved with short daily dialysis treatment. Current in-center hemodialysis machines do not fulfill the requirements needed for self-care home hemodialysis (HHD) treatment. In line with the reviviscence of home therapy, several hemodialysis devices have been developed and deployed for treatment. Physidia S is one of these new dialysis delivery systems featuring an appealing design and functionalities intended for daily HHD treatment.

METHODS

In this French multicenter proof-of-concept study enrolling 13 training centers, we report our preliminary experience with a special focus on quantifying clinical performances in short daily HHD treatment performed during the training period of the patients.

RESULTS

Among the 80 patients included in this study, a total of 249 sessions could be analyzed. Dialysis dose, estimated from weekly standardized Kt/V, was maintained at 2.22 [1.95-2.61] with a normalized protein catabolic rate of 0.93 [0.73-1.18] g/kg/24 h. Furthermore, anemia and nutritional status were adequately controlled as indicated by 11.6 ± 1.4 g/dL of hemoglobin level and 39.4 ± 5.7 g/L of serum albumin as well as electrolyte disorders.

CONCLUSIONS

The safety and efficacy of the S therapy concept relying on a short daily hemodialysis treatment using a bagged delivery system are in total agreement with daily HHD recommendations. Clinical performances are aligned to the metabolic needs of the vast majority of HHD patients. Currently ongoing studies at home will provide further evidence and value of this therapeutic approach.

摘要

背景

越来越多的科学证据表明,采用每日短时透析治疗可改善血液透析患者的临床结局。目前的中心内血液透析机无法满足家庭自我护理血液透析(HHD)治疗的需求。随着家庭治疗的复兴,已开发并部署了几种血液透析设备用于治疗。Physidia S是这些新型透析输送系统之一,具有吸引人的设计和适用于每日HHD治疗的功能。

方法

在这项纳入13个培训中心的法国多中心概念验证研究中,我们报告了初步经验,特别关注对患者培训期间进行的每日短时HHD治疗中的临床性能进行量化。

结果

本研究纳入的80例患者中,共可分析249次透析治疗。根据每周标准化Kt/V估算的透析剂量维持在2.22[1.95 - 2.61],标准化蛋白分解代谢率为0.93[0.73 - 1.18]g/kg/24小时。此外,贫血和营养状况得到充分控制,血红蛋白水平为11.6±1.4g/dL,血清白蛋白为39.4±5.7g/L,且无电解质紊乱。

结论

依赖袋装输送系统进行每日短时血液透析治疗的S治疗理念的安全性和有效性完全符合每日HHD的建议。临床性能符合绝大多数HHD患者的代谢需求。目前正在进行的家庭研究将为这种治疗方法提供进一步的证据和价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c73e/9031690/c5cffd907e2b/jcm-11-02123-g001.jpg

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