Experimental Design and Clinical Observation of Modialysis Apparatus

摘要

Objective To evaluate the clinical safety and efficacy of polyethersulfone membrane hollow fiber dialyzer Enttex^(TM)-16LF(E60)in treating patients with end stage renal disease caused by a variety of reasons.Methods This clinical trialwas designed as a randomized,open,two-phase crossover and positive control,non-inferiority study.To evaluate the indicators of blood routine test,serum biochemical indexes,blood gas analysis,vital signsbefore and after hemodialysis,and the adverse events were recorded indetail.Results There was no significant difference in creatinine,urea,creatinine clearance and electrolytes between Enttex TM-16LF dialyzer and control dialyzer before and after hemodialysis,no adverse event associated with the Enttex^(TM)-16LF dialyzer was found during the study.Conclusions The Enttex^(TM)-16LF dialyzeris effective and safe for hemodialysis in patients with end stage renal disease.