CAJ | 학술논문

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系列高通最透析器临床使用安全有效.
목적 평개REXEEDTM계렬고통량투석기적료효화안전성.방법 연구대상위상해량가의원규률성혈액투석(혈투)환자72례.채용수궤화교차설계,채용REXEEDTM불동막면적(1.5 m2화2.1 m2)15AC、15UC、21AC、21UC투석기(시험조)이급APS-15U、BIO-HX100투석기(대조조),분별안2개3×3랍정방진행투석치료.검측투석기뇨소、기항、린、β2미구단백청제솔,뇨소、기항하강비솔급치료전후안전성지표.관찰급기록불량반응.결과 시험조15AC、15UC투석기적뇨소、기항청제솔균현저대우대조조APS-15U[분별위(222.07±18.74)ml/min、(220.23±26.26)ml/min비(199.56±14.21)ml/min;(176.73±16.41)ml/min、(175.22±25.94)ml/min비(165.42±14.68)ml/min,균P<0.05].량조간린화β2미구단백청제솔차이균무통계학의의.21AC、21UC투석기뇨소、기항、β2미구단백청제솔균현저대우대조조BIO-HX100[분별위(230.59±15.24)ml/min、(233.96±7.06)ml/min비(203.43±36.66)ml/min;(183.50±25.90)ml/min、(181.05±23.94)ml/min비(166.25±29.82)ml/min;(111.77±53.42)ml/min、(125.54±51.99)ml/min비(42.39±4.81)ml/min,균P<0.05].량조간린청제솔차이무통계학의의.시험조4충투석기뇨소하강비솔균대우89%,치료전후안전성감측지표균무명현변화.불량반응화불량사건소이정도경,무엄중불량반응.결론 REXEEDTM-AC、UC계렬고통최투석기림상사용안전유효.
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.