中国血液净化

›› 2010, Vol. 9 ›› Issue (8): 429-432.doi: 10.3969/j.issn.1671-4091.2010.08.009

• 临床研究 • 上一篇    下一篇

国产PES14HF聚醚砜高通量透析器对血液透析患者疗效和安全性临床随机对照试验

张伟明 　蒋更如 　钱家麒 　王炳顺 　朱 淳 　王咏梅 　黄海东 　严玉澄 　倪兆慧   

  1. 上海交通大学医学院附属仁济医院肾脏科
  • 收稿日期:2010-05-21 修回日期:1900-01-01 出版日期:2010-08-12 发布日期:2010-08-12
  • 通讯作者: 钱家麒

A randomized controlled clinical trial on safety and effectiveness of PES14HF polyethersulfone high-flux dialyzer in hemodialysis patients

ZHANG Wei-ming, JIANG Geng-ru, QIAN Jia-qi,WANG Bing-shun, ZHU Chun2, WANG Yong-mei, HUANG Hai-dong, YAN Yu-cheng, NI Zhao-hui.   

  1. 1Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200001, China; 2Department of Nephrology, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200092, China; 3Department of Biostatistics, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China
  • Received:2010-05-21 Revised:1900-01-01 Online:2010-08-12 Published:2010-08-12

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摘要：
【摘要】目的 评价国产PES14HF聚醚砜高通量透析器的疗效和安全性。方法 选择上海两家医院规律性血液透析患者72例。采用平行对照设计，试验组采用国产PES14HF透析器，对照组采用日本PES-150DS透析器。检测透析器尿素、肌酐、磷、微球蛋白清除率和下降比率以及试验前后实验室评价指标。观察及记录不良反应。结果 两组间尿素、肌酐、磷清除率差异均无统计学意义(P＞0.05)。试验组微球蛋白清除率显著大于对照组，分别为(44.50±29.57)ml/min和(25.75±11.27)ml/min，差异有统计学意义(P＜0.05)。试验组尿素下降比率大于70%，两组间尿素、肌酐、磷下降比率差异均无统计学意义(P＞0.05)。试验组微球蛋白下降比率显著大于对照组，分别为(38.87%±12.48%)和(29.53%±17.71%)，差异有统计学意义(P＜0.05)。试验组尿素下降比率有效率显著大于对照组，分别为100%和88.57%，差异有统计学意义(P＜0.05)。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PES14HF聚醚砜高通量透析器临床使用安全、有效。

关键词: 高通量血液透析, 聚醚砜透析器, 清除率

Abstract: 【Abstract】Objective To evaluate the safety and efficacy of PES14HF polyethersulfone high-flux dialyzer. Methods Seventy-two patients with stable end stage renal disease and receiving hemodialyis 3 times weekly were enrolled in this randomized parallel control study. High-flux hemodialysis was performed for 4h using PES14HF dialyzer (experiment group) or PES-150DS dialyzer (control group), and the study lasted for one week. The clearances of urea, creatinine, phosphate and β2-microglobulin were calculated. Reactions and adverse events were recorded. Results No significantly differences in serum level changes and clearances of urea, creatinine and phosphate were found between the 2 groups. β2-microglobulin clearance was significantly higher in experiment group (44.50±29.57ml/min) than in control group 25.75±11.27ml/min, P<0.05), so did the decrease magnitude of serum β2-microglobulin (38.87±12.48% vs. 29.53±17.71%, P<0.05). Urea clearance and the higher blood urea improved after the treatment in both groups, and the lowering of blood urea was more significant in experiment group (100%) than in control group (88.57%, P<0.05). Conclusion PES14HF dialyzer is efficient and safe for clinical application.

Key words: Polyethersulfone dialyzer, Clearance

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