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The clinical evaluation of novel polymethyl methacrylate membrane with a modified membrane surface: a multicenter pilot study

机译:改性膜表面新型聚甲基丙烯酸甲酯膜的临床评价:多中心试验研究

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Polymethyl methacrylate (PMMA) membranes have the unique property of adsorption, which can remove medium- and large-weight molecular substances that cannot be removed by normal hemodialysis and hemodiafiltration. Filtryzer? NF (NF) is a newly developed PMMA membrane that suppresses platelet adhesion on the membrane surface and retains an adsorption property. NF is expected to improve inflammatory conditions and clinical symptoms in hemodialysis patients compared with conventional PMMA membranes. Thirty-seven maintenance hemodialysis patients treated with polysulfone (PS) membranes and who had detectable chronic inflammation were enrolled into the study. The patients were randomly allocated into the NF and PS groups and observed for 1?year. C-reactive protein (CRP) values were measured as the primary endpoint. Nutrition, blood cell count, and dialysis itchiness were evaluated as secondary endpoints. Significant differences in CRP values were not found between the NF and PS groups. In the PS group, the creatinine generation rate (%CGR) and platelet count, which were included in nutrition and blood cell count, respectively, significantly decreased after 6 and 9?months compared with the start of study, but these parameters did not significantly change in the NF group within 1?year. Dialysis itchiness in the NF group was significantly improved compared with the PS group after 9?months. Our results showed that a new PMMA membrane, NF, has a potential to maintain nutritional conditions and the platelet counts and improve dialysis itchiness. This study is retrospectively registered with the Clinical Trials Registry of the University Hospital Medical Information Network on February 17, 2015 (registration ID, UMIN000016567 ).
机译:聚甲基丙烯酸甲酯(PMMA)膜具有可吸附的独特性,其可以去除通过正常血液透析和血液透析不能除去的中等和大量的分子物质。 Filtryzer? NF(NF)是一种新开发的PMMA膜,其抑制膜表面上的血小板粘附,并保留吸附性。预计与常规PMMA膜相比,NF预计将改善血液透析患者的炎症病症和临床症状。用聚砜(PS)膜治疗的三十七种维持血液透析患者,并达到了检测到的慢性炎症。将患者随机分配到NF和PS组中,并观察到1岁。将C-反应蛋白(CRP)值作为初级终点测量。营养,血细胞计数和透析瘙痒被评估为次级终点。在NF和PS组之间找不到CRP值的显着差异。在PS组中,分别包括在营养和血细胞计数中,分别在6和9的营养和血细胞计数中含有肌酸酐生成率(%CGR)和血小板计数,而与研究开始相比,数月,但这些参数没有显着在1年内改变NF组。与9月后的PS组相比,NF组在NF组中的透析瘙痒明显改善。我们的研究结果表明,新的PMMA膜NF有可能保持营养状况和血小板计数,并改善透析瘙痒。本研究回顾性地注册了2015年2月17日大学医院医疗信息网络的临床试验登记处(注册ID,UMIN000016567)。

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