REXEEDTM系列高通量透析器疗效和安全性的临床随机对照试验

目的 评价REXEEDTM系列高通量透析器的疗效和安全性。 方法 研究对象为上海两家医院规律性血液透析（血透）患者72例。采用随机化交叉设计，采用REXEEDTM不同膜面积（1.5 m2和2.1 m2）15AC、15UC、21AC、21UC透析器（试验组）以及APS-15U、BIO-HX100透析器（对照组），分别按2个3×3拉丁方进行透析治疗。检测透析器尿素、肌酐、磷、β2微球蛋白清除率，尿素、肌酐下降比率及治疗前后安全性指标。观察及记录不良反应。 结果 试验组15AC、15UC透析器的尿素、肌酐清除率均显著大于对照组APS-15U分别为（222.07±18.74） ml/min、（220.23±26.26） ml/min比（199.56±14.21） ml/min；（176.73±16.41） ml/min、（175.22±25.94） ml/min比 （165.42±14.68） ml/min，均P < 0.05]。两组间磷和β2微球蛋白清除率差异均无统计学意义。21AC、21UC透析器尿素、肌酐、β2微球蛋白清除率均显著大于对照组BIO-HX100分别为（230.59±15.24） ml/min、（233.96±7.06） ml/min比（203.43±36.66） ml/min；（183.50±25.90） ml/min、（181.05±23.94） ml/min比（166.25±29.82） ml/min；（111.77±53.42） ml/min、（125.54±51.99） ml/min比（42.39±4.81） ml/min，均P < 0.05]。两组间磷清除率差异无统计学意义。试验组4种透析器尿素下降比率均大于89%，治疗前后安全性监测指标均无明显变化。不良反应和不良事件少而程度轻，无严重不良反应。 结论 REXEEDTM-AC、UC系列高通量透析器临床使用安全有效。

A randomized controlled trial for the efficacy and safety of REXEEDTM series highflux dialyzer

Objective To evaluate the efficacy and safety of REXEEDTM series highflux dialyzer. Methods A randomized cross-over study of 3×3 Latin square was designed based on the surface area of dialyzer membrane (1.5 m2 and 2.1 m2). Seventy-two stable maintenance hemodialysis (MHD) patients from Shanghai Renji Hospital and Ruijin Hospital were enrolled in this study for 3 consecutive weeks. REXEEDTM-15AC, 15UC, 21AC, 21UC dialyzers were used as trial group and APS-15U,BIO-HX100 dialyzers were used as control group. The clearances of urea, creatinine, phosphorus and β2-microglobulin were calculated. Adverse event and adverse reactions were recorded. Results There were significantly higher urea and creatinine clearance in 1SAC and 15UC dialyzers as compared to APS-15U dialyzer (222.07±18.74) mi/min, (220.23±26.26) ml/min vs (199.56±14.21) ml/min; (176.73±16.41) ml/min, (175.22±25.94) ml/min vs (165.42±14.68) ml/min, all P<0.05]. There were significantly higher urea, creatinine and β2-microglobulin clearance in 21AC and 21UC dialyzer as compared to BIO-HX100 dialyzer (230.59±15.24) ml/min, (233.96±7.06) ml/min vs (203.43±36.66) ml/min; (183.50±25.90) ml/min, (181.05±23.94) ml/min vs (166.25±29.82) ml/min; (111.77±53.42) ml/min, (125.54±51.99) ml/min vs (42.39±4.81) ml/min; all P<0.05]. There was no significant difference of phosphorus clearance between REXEEDTM series dialyzers and control dialyzers. The efficiency of urea clearance and urea reduction ratio could achieve clinical targets in REXEEDTM series. Conclusion REXEEDTM series highflux dialyzers are effective and safe for clinical application.