Evaluation of safety and effectiveness of domestically produced high-flux dialyzer for hemodialysis patients

Objective:To evaluate the clinical safety and efficacy of domestically produced high-flux HF12 and HF16 polysulfon dialyzer in maintenance hemodialysis patients' treatments of chronic renal failure,which contrast with F60S polysulfon dialyzer of Fresenius. Methodology:One hundred and thirty-five patients with maintenance hemodialysis were admitted to the center of blood purification of Nanjing Institution of Nephrology.By random parallel controlled trial design,they were divided into three groups,the experiment group of HF12 (n=45),the experiment group of HF16 (n=45) and the control group of F60S (n=45), and each of them worked 4 hours.Through test the decrease rate and the clearance of patients with urea nitrogen,serum creatinine,phosphate,β2-micro globulin,and test hemoglobin,white blood cells,platelets,serum albumin,C3 which form peripheral blood before and after experiment.d the efficacy and safety of the experiment group on the basis of laboratory parameters.Observed and recorded the opposite events and opposite reactions. Results:(1)They were 85 males and 50 females with an average age of (39±11) years old ranged form 19 to 62.All of patients were completed the clinical trial,no case was lost to follow-up.(2)There were no significant differences in the decrease rate and the clearance of serum creatinine,urea nitrogen,phosphate,β2-micro globulin.The urea nitrogen clearance of HF12 group and HF16 group were lower than that of control group [(184.0±62.8)ml/min,(196.0±37.9)ml/min vs (200.6±23.2)ml/min],there were no statistically significant differences among them (P0.05).The decrease rate of urea nitrogen in the experiment group and the control group were above 60%,among the three groups there were no statistical difference (P0.05).β2-microglobulin decrease rate of HF12 group was lower than those of the control group [(41.3±15.6)% vs (44.0±16.8)%],β2-microglobulin decrease rate of HF16 group was higher than those in the control group [(47.0±15.0)% vs (44.0±16.8)%],there were no statistically significant differences among them (P0.05).(3)Before and after,there were no sharp changes in those three groups with hemoglobin,white blood cells,platelets,serum albumin,and C3 of peripheral blood.(4)Those three groups hadn't occurred opposite events,also with no opposite reaction. Conclusion:Domestically produced high-flux HF12,HF16 polysulfon dialyzer could eliminate small molecules toxins effectively as imported F60S dialyzer,and also could have good effects for middle-molecular elimination,without obvious adverse events.