国产聚醚砜血液透析滤过器的安全性和有效性

Evaluation of safety and efficacy of polyether membrane haemodiafilters in hemodiafiltration

目的评价聚醚砜血液透析滤过器(PES18HDF)在血液透析滤过治疗中的安全性和有效性。方法选取2014年2—7月复旦大学附属中山医院和上海交通大学医学院附属仁济医院收治的76例终末期肾病患者。随机分为试验组和对照组,各38例,比较国产聚醚砜膜血液透析滤过器(试验组)与进口聚砜膜血液透析滤过器(Diacap?αPolysulfone+HiFlo)(对照组)在维持性血液透析患者进行血液透析滤过治疗中的安全性和有效性。结果试验组血β2-MG下降率显著高于对照组,差异有统计学意义(P=0.0003);试验组尿素清除率显著高于对照组,差异有统计学意义(P=0.0042);试验组超滤系数显著高于对照组,差异有统计学意义(P=0.024);两组肌酐清除率比较,差异无统计学意义(P=0.222);两组不良事件比较,差异无统计学意义(P=0.200)。结论国产聚醚砜血液透析滤过器对中分子溶质(如β2-MG)及小分子溶质(如尿素、肌酐等)具有较好的清除效能,其对溶质的清除效能及超滤性能均优于进口血液透析滤过器,安全性较好。

Objective To evaluate the safety and efficacy of the polyether membrane haemodiafilters(PES18 HDF)in the treatment of hemodiafiltration.Methods 76 patients were enrolled in the trial.There were 38 cases in each group.Maintenance hemodialysis patients were randomized to polyether membrane haemodiafilters(PES18 HDF)and polysulfone membrane haemodiafilters(Diacap?αPolysulfone+HiFlo).The safety and efficacy indicators were observed.Results Theβ2-MG in experimental group decreased,which was significantly higher than that of the control group of(P=0.0003).The urea clearance rate in experimental group was significantly higher than that in the control group(P=0.0042).The creatinine clearance rate was no significant difference between the two groups(P=0.2221).The adverse events was no significant difference between the two groups(P=0.2000).Conclusion The polyether membrane haemodiafilters was confirmed to have better urea andβ2-MG removal with good safety.The long-term clinical consequences of better uremic toxin removal should be prospectively assessed.