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Clinical Efficacy of High Flux Hollow PES Membrane Fiber Dialyzer EnttexTM-18HF

临床医学工程 2021年第S1期 13-19页

作者： YUN Chen ZHA Aiyun HE Xiaofan CHEN Yu KE Jun YANG Lifeng YU Zongchao LI Yunyi ZHU Lin XU Jun SHI Mingjie aojeong chiwa CAO Rui TANG Shuifu WANG Boxun CHEN Gangyi LU Yongpin HU Bo Wolfganng Pommer Stanislao Morgera Bernhard Kramer Berthold Hocher LIU Haiping HE Yongcheng LI Qiang YIN Lianghong Department of Nephrology the First Affiliated Hospital of Ji'nan University Charite Universitatsmedizin Berlin Campus Mitte Key Laboratory of Cardiopulmonary Bypass Bachinery State Drug Administration College of Pharmacy Ji'nan University Kiang Wu Hospital Department of Nephrology the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine University Medicai Centre Mannheim Department of Medicine Nephrology The Second People's Hospital of Lianping County Department of Nephrology Shenzhen Second People's Hospital Department of Nephrology Shenzhen Hengsheng Hospital University Medical Centre Mannheim Department of Medicine Nephrology Guangzhou Enttex Medical Products Industrial Co. Ltd.

Objective In this clinical trial,a two center,randomized,open,two-stage cross positive control and non-inferiority verification design was used to evaluate the application of the hollow flier member PES membrane produced by 3M membrane of Germany in the production of high-throughput hollow PES membrane fiber dialyzer Enttex-18HF （E70S） for hemodialysis of patients with multiple causes of acute and chronic renal failure Safety and *** Enttex-18HF dialyzer was used in the experimental group and high flux H-18P dialyzer produced by Guangzhou Bain company was used in the control group.76 patients receiving maintenance hemodialysis were included in a random,open label,two-stage,positive crossover and non-inferiority validation *** primary efficacy parameters:creatinine clearance,dialyzer urea clearance and β-microglobulin （β-MG）;the secondary efficacy parameters:changes of general creatinine,urea nitrogen clearance rate,urea reduction rate （URR）,Kt/V value,body weight,ultrafiltration rate,electrolyte,C-reactive protein （CRP） and blood gas analysis indicators;meanwhile safety and biocompatibility were assessed to observe the clinical efficacy and safety of the study *** The main evaluation indexes creatinine clearance rate,urea clearance rate and β-MG reduction rate in the test group were not inferior to those in the control group,and there was no significant difference between the two *** was no significant difference between the dialyzer and the control dialyzer in the total creatinine clearance rate,urea clearance rate,URR,β-MG,CRP,electrolyte change,blood routine test and liver function change *** was no significant difference in clinical side effects between the comparison test dialyzer and the control *** were no serious adverse events in the two *** In this clinical trial,it is confirmed that the high-throughput hollow PES membrane fiber dialyzer Enttex-18HF （E70S）produced by holow fliber

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