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台灣研發中空纖維透析器之性能特性試驗

Performance Characteristics of Hollow Fiber Hemodialyzers Developed in Taiwan

摘要


新開發的血液透析器必須測定其性能特性,以評估器材設計與血液透析程序的可用性。本研究測試國內研發的中空纖維透析器之溶質廓清率與超過濾性能,測量方法全部遵照國際標準1SO 8637:2010。樣本透析器有兩種型號(model-160與180),各取3個透析表執行試驗。溶質廓清率(K)測量採用透析流體為測試溶液(37℃),添加測試溶質有尿素、肌酸酐、磷酸鹽與維他命B12,血液流量與透析液流量涵蓋廠商標示的使用範園。超過濾係數(Kuf)採用肝素化含血球比容(32±2)%及蛋白質含量(60±5)g/L之豬全血為測試溶液(37℃)。過篩係數測量採用肝素化含蛋白質(60±5)g/L之豬血漿為測試溶液(37℃),將白蛋白、ß2-微球蛋白與菊糖添加入測試溶液。所有測試皆直接在Fresenius 4008洗腎機上依標準作業程序執行。實驗數據皆以平均值±標準差表示。溶質之質傳面積係數(K0A)加以計算得到。並利用理論公式計算不同流量之下的廓清率理論值,與測試結果比較,廓清率理論值之偏差在±5%以內,可提供臨床應用時估算廓清率之用。全部試驗結果證實兩型透析器皆具有溶質高通過率與高通量特性。與已上市廣用高通過率透析器比較,具有實質等同性。本產品兩型透析器皆具有臨床應用的可行性。

並列摘要


Determination of the performance characteristics of hemodialyzers newly developed is indispensable for assessing device design and the hemdialysis process. This study measured the solute clearances and ultrafiltration properties of the hollow fiber dialyzers developed in Taiwan according the international standard ISO 8637 : 2010. The test were performed on 3 dialyzers each from two model types( model-160 and 180) The solute clearances (K) of urea, creatinine, pbosphate and vitamin B12 were determined with dialysis fluid as test solution at 37℃ with blood and dialysate flow rates covering the manufacturer's specified ranges. The test solution used to measure the ultrafiltration coefficients (KUF) was heparinized pig's whole blood with a hematocrit of ( 32±3) % and a protein content of(60±5)g/L at 37℃. The sieving coefficients for albumin, inulin, β2-microglobulin were measured with test solution of heparinized pig's plasma with a protein content of (60±5)g/L at 37℃. All tests were run on a standard calibrated Fresenius 4008 hemodialysis machine. All data presented here are expressed as the mean ±SD (standard deviation ) .The mass transfer area coefficients (KoA) were included. The theoretical clearances at specified blood and dialysate flow rates were also discussed. The deviations of tbeoretical prediction of clearances from test results were all within 5%. All test results show that both two types of dialyzers are highly permeable and high-flux. They are equivalent to commercially available high permeable hemodialyzers. The two types of dialyzers may have the potential of clinical use.

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