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題 名 | Clinical Study of A Nano Structure FX80 Hollow Fiber Dialyzer=奈米生產技術Fx80透析器臨床研究 |
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作 者 | 鄭振廷; 吳明訓; 林立倫; 許秀萍; 張慧瑩; 許尚文; 楊惠明; | 書刊名 | 臺灣腎臟醫學會雜誌 |
卷 期 | 16:2 2002.06[民91.06] |
頁 次 | 頁73-78+97 |
分類號 | 410.025 |
關鍵詞 | 血液透析治療; 透析器; Helixone; Biocompatibility; Urea reduction rate; Hollow handing; |
語 文 | 英文(English) |
中文摘要 | 血液透析治療中理想的透析器應符合高度生物相容性,對尿毒中小分子有高效率廓清率及護理人員易於操作。於公元2000年一種使用polysulphone透析膜配合奈米專利技術生產的新式Helixone透析膜已經量產,配合螺旋型式血液入口與密實中空纖維管充填設計的FX系列透析器已在歐美開始使用。由於其獨特設計賦予FX透析器有高度生物相容性,最佳化中小分子廓清率,及護理人員方便操作。本臨床研究中35位ESRD病患進行六週交叉使用F80透析器與FX80透析器,觀察生物相容性中治療開始15分鐘舋血球、血小板、及補體C5a下降百分比;透析前後血中尿素氮、肌肝酸及磷減少百分比。在護理人員操作方便性觀察透析器開始充及結束回血所需時間及使用生理鹽水用量。結果顯示FX80透析器中生物相容性與F80相當;尿素氮、肌酐酸及磷的清除率均為FX80較佳,唯因樣本數較低故統計差異未達顯著程度;其中磷清除率已接近顯著(p=0.08)。於操作方便性中,FX80透析器無論在充填或回血所需時間及生理鹽水用量,均較F80使用量為低(p<0.0001)。總結FX80透析器中Helixone透析膜符合高度生物相容性、較佳小分子尿毒清除率及顯著操作方便性。 |
英文摘要 | A new polysulfone hollow fiber, Helixone, manufactured using nano-controlled spinning technology has recently been introduced. This membrane has been mounted in a redesigned dialyzer, the FX Class (Fresenius Medical Care, Germany) with spiral blood inlet design and increased fibre packing density. It has unique biocompatibility, optimized clearance performance, and simplified handling characteristics. In a 6-week crossing-over clinical study we compared the traditional F80 dialyzer and FX80 dialyzer. The 15-minute percentage reduction rate on leukocyte, platelet, complement C5a was used as the observed parameter for membrane biocompatibility; as well as intradialytic reduction rate of blood urea nitrogen, creatinine, and phosphate for performance on small molecular solutes removal. To measure ease of handling, we compared the volume of normal saline and nursing time used in priming and wash-back of both dialyzer types. The results showed that the FX80 helixone dialyzer maintained good biocompatibility compared to that of the F80. Removal rate of small solutes of blood urea nitrogen, creatinine, and phosphate were higher in the FX80 than the F80 but the difference was not statistically significant which is possibly due to small sample size. The superior reduction ratio for phosphate with the FX approached significance (p=0.08). Easier handling of the FX80 compared to the F80 was confirmed by the need for less volume for prime and wash-back (P<0.0001) and less nursing time consumed by these procedures. We conclude that the new helixone FX80 dialyzer maintains good biocompatibility, and has a trend to higher reduction rate of small solutes compared to the F80. Moreover, the Helixone hollow fiber is easier for handling during priming and rinsing back during dialysis. |
本系統中英文摘要資訊取自各篇刊載內容。