摘要: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 EnttexTM-18HF (E70S) for hemodialysis of patients with multiple causes of acute and chronic renal failure Safety and effectiveness.Methods EnttexTM-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 study.The primary efficacy parameters:creatinine clearance,dialyzer urea clearance and β2-microglobulin (β2-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 devices.Results The main evaluation indexes creatinine clearance rate,urea clearance rate and β2-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 groups.There was no significant difference between the dialyzer and the control dialyzer in the total creatinine clearance rate,urea clearance rate,URR,β2-MG,CRP,electrolyte change,blood routine test and liver function change test.There was no significant difference in clinical side effects between the comparison test dialyzer and the control dialyzer.There were no serious adverse events in the two groups.Conclusions In this clinical trial,it is confirmed that the high-throughput hollow PES membrane fiber dialyzer EnttexTM-18HF (E70S)produced by ho