国产PES14LF聚醚砜透析器对血液透析患者疗效和安全性的临床随机对照试验

目的 评价国产PES14LF聚醚砜低通量透析器对维持性血液透析（MHD）患者的疗效和安全性。 方法 选择上海两家医院72例MHD患者为研究对象，进行随机平行对照试验。试验组采用国产PES14LF透析器，对照组采用德国F6聚砜膜透析器。检测透析器尿素、肌酐、磷清除率和下降比率，以及试验前后实验室指标。观察及记录不良反应。 结果 两组间尿素、肌酐清除率差异均无统计学意义。试验组磷清除率显著大于对照组（144.57±27.83） ml/min比（117.15±22.77） ml/min，P < 0.05]。试验组尿素下降比率大于65%。两组间尿素、肌酐、磷下降比率差异均无统计学意义。两组间尿素清除有效率和尿素下降比有效率差异均无统计学意义。两组治疗前后实验室评价指标均无明显变化，不良事件少而程度轻，无不良反应。结论 国产PES14LF聚醚砜低通量透析器临床使用安全、有效。

A randomized controlled trial of efficacy and safety of PES14LF polyethersulfone dialyzer on hemodialysis patients

Objective To evaluate the efficacy and safety of PES14LF polyethersulfone highflux dialyzer on maintenance hemodialysis (MHD) patients. Methods A total of 72 MHD patients from two hospitals in Shanghai were enrolled in a randomized parallel controlled study. Conventional hemodialysis was performed for 4 h with PES14LF dialyzer in trial group and with German F6 dialyzer in control group. For each patient the study lasted one week. The clearances of urea, creatinine and phosphate were calculated. Adverse event and adverse reaction were recorded. Results There were no significant differences of urea and creatinine clearance and reduction ratio between trial and control group. The phosphate clearance in trial group was significantly higher than that in control group (144.57±27.83) ml/min vs (117.15±22.77) ml/min, P<0.05]. There was no significant difference of phosphate reduction ratio between trial and control group. The efficiency of urea clearance and urea reduction ratio achieved clinic effective target in two groups and no significant differences in above indexes between two groups were found. Conclusion PES14LF dialyzer is effective and safe for clinical application.