Objective The dialysate membrane can be classified into acetate membrane and synthetic membrane,while the latter can be further divided into polysulfone,polyacrylonitrile,etc.Polyethersulfone membrane is high molecula...Objective The dialysate membrane can be classified into acetate membrane and synthetic membrane,while the latter can be further divided into polysulfone,polyacrylonitrile,etc.Polyethersulfone membrane is high molecular membrane material with excellent biocompatibility,stable mechanical properties,high temperature and pressure resistance,and good cleaning performance,which has been applied for more than 10 years.This trial is to assess the safety and efficacy of hollow polysulfone membrane fiber dialyzer with pattern number Enttex^(TM)-16LF(E60)for hemodialysis in patients with acute or chronic renal failure due to multiple factors.Methods Totally 76 patients receiving maintenance hemodialysis were included in a two-site,random,open label,two-stage,positive crossover and non inferiority validation study.The clinical efficacy and safety of the test device were observed,which was a hollow fiber dialyzer produced by Guangzhou Enttex Medical Products Co.,Ltd.,with polyethersulfone membrane imported from Germany.It was a low flux dialyzer with the pattern number of EnttexTM-16LF(E60).Inclusion criteria:①patients with acute or chronic renal failure due to various reasons who needed hemodialysis;②18 to 80 years old,gender unlimited;③patients who received stable dialysis for more than 3 months,regular hemodialysis 3 times a week,4 h at each time,blood flow rate of 200~350ml/min;④using bicarbonate dialysate at a flow rate of 500ml/min;⑤patients with arteriovenous fistula or who received artificial blood vessel puncture dialysis;received anticoagulation by heparin or low molecular weight heparin.Exclusion criteria:①patients needing heparin free dialysis for severe anemia,tumor and active bleeding;②patients with severe cardiac(gradeⅢcardiac function),hepatic(severe hepatitis and cirrhosis)and pulmonary diseases(severe respiratory failure).Results Comparison of parameters,including the changes of Kt/V,general creatinine and urea clearance rates and URR(urea reduction rate)shows no statistical significance in differences between the two devices,indicating that the test and control devices can equally and effectively eliminate toxins including creatinine and urea,etc.PPP and MITTP results are consistent.Comparison of ultrafiltration rates between two groups of patients shows no statistical difference.PPP and MITTP results are consistent,indicating that both the test device and control device can effectively eliminate water.In MITTP,electrolytes including K^+,Na^+,Cl^-,Ca^2+,HCO3^-,etc.show no statistical significance in difference between the test and control devices before and after dialysis(P>0.05).After treating by using test and control devices,body weight,serum potassium and phos-phorus all significantly decrease(P<0.001);serum Ca^2+,PO2,PCO2and HCO3^-all significantly increase(P<0.001).These results indicate that both the test and control devices can effectively eliminate serum potassium and phosphorus,and eliminate excess water in body,maintain the balance between liquid and electrolytes in patients.PPP and MITTP results are consistent.Conclusion This clinical trial confirms that hollow polyethersulfone membrane fiber dialyzer can be safely and effectively used in hemodialysis therapy.展开更多
基金Guangdong Provincial Science and Technology Department Fund Project（507204531040）Guangdong Provincial Science and Technology Plan Fund Project（2013b9040004）
文摘Objective The dialysate membrane can be classified into acetate membrane and synthetic membrane,while the latter can be further divided into polysulfone,polyacrylonitrile,etc.Polyethersulfone membrane is high molecular membrane material with excellent biocompatibility,stable mechanical properties,high temperature and pressure resistance,and good cleaning performance,which has been applied for more than 10 years.This trial is to assess the safety and efficacy of hollow polysulfone membrane fiber dialyzer with pattern number Enttex^(TM)-16LF(E60)for hemodialysis in patients with acute or chronic renal failure due to multiple factors.Methods Totally 76 patients receiving maintenance hemodialysis were included in a two-site,random,open label,two-stage,positive crossover and non inferiority validation study.The clinical efficacy and safety of the test device were observed,which was a hollow fiber dialyzer produced by Guangzhou Enttex Medical Products Co.,Ltd.,with polyethersulfone membrane imported from Germany.It was a low flux dialyzer with the pattern number of EnttexTM-16LF(E60).Inclusion criteria:①patients with acute or chronic renal failure due to various reasons who needed hemodialysis;②18 to 80 years old,gender unlimited;③patients who received stable dialysis for more than 3 months,regular hemodialysis 3 times a week,4 h at each time,blood flow rate of 200~350ml/min;④using bicarbonate dialysate at a flow rate of 500ml/min;⑤patients with arteriovenous fistula or who received artificial blood vessel puncture dialysis;received anticoagulation by heparin or low molecular weight heparin.Exclusion criteria:①patients needing heparin free dialysis for severe anemia,tumor and active bleeding;②patients with severe cardiac(gradeⅢcardiac function),hepatic(severe hepatitis and cirrhosis)and pulmonary diseases(severe respiratory failure).Results Comparison of parameters,including the changes of Kt/V,general creatinine and urea clearance rates and URR(urea reduction rate)shows no statistical significance in differences between the two devices,indicating that the test and control devices can equally and effectively eliminate toxins including creatinine and urea,etc.PPP and MITTP results are consistent.Comparison of ultrafiltration rates between two groups of patients shows no statistical difference.PPP and MITTP results are consistent,indicating that both the test device and control device can effectively eliminate water.In MITTP,electrolytes including K^+,Na^+,Cl^-,Ca^2+,HCO3^-,etc.show no statistical significance in difference between the test and control devices before and after dialysis(P>0.05).After treating by using test and control devices,body weight,serum potassium and phos-phorus all significantly decrease(P<0.001);serum Ca^2+,PO2,PCO2and HCO3^-all significantly increase(P<0.001).These results indicate that both the test and control devices can effectively eliminate serum potassium and phosphorus,and eliminate excess water in body,maintain the balance between liquid and electrolytes in patients.PPP and MITTP results are consistent.Conclusion This clinical trial confirms that hollow polyethersulfone membrane fiber dialyzer can be safely and effectively used in hemodialysis therapy.
