【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。
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
. 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[J]. 中国血液净化, 2010
, 9(8)
: 429
-432
.
DOI: 10.3969/j.issn.1671-4091.2010.08.009
【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.
