影响血液透析机透析效果的因素及其维护

本文介绍了透析机的基本原理、影响透析效果的主要因素,以及透析机的维护。为使医护人员了解透析机的性能,正确使用机器,做好机器的维护,提供参考。     

Lingual amyloidosis--a rare complication of long-term haemodialysis.

Case A 54 year-old male was diagnosed with polycystic kidney diseasein uraemic stage, and had been dialysed for 25 years, sincethe age of 29 years. He received haemodialysis by artificialkidneys with unsubstituted cellulose membrane for the first16 years. Carpal tunnel syndrome (CTS) developed soon     

In vitro and in vivo evaluation of a new dialyzer.

BACKGROUND: Recent dialyzer-related developments have concentrated upon the improvement of performance and biocompatibility. The focus of these developments was predominantly on the membrane itself. A newly developed high-flux dialyzer (FX60) with an advanced Fresenius Polysulfone) membrane (Helixone) overcomes this limitation and has several design-related advantages attributed to the redesign of the individual functional components. For the first time, polypropylene was selected as the material for the dialyzer housing. Both the fibre and the fibre-bundle geometry were refined with the aim of improving overall performance and to reduce dialysate consumption. METHODS: This study aims at investigating the in vitro and in vivo performance of the new FX60 dialyzer with the focus on dialysate flow distribution and dialysate consumption. A new method to analyse dialysate flow distribution, based on local clearances, is suggested. The effect of reducing dialysate flow from 500 to 300 ml/min is investigated in vivo. RESULTS: K(0)A(urea), a common measure to quantify device performance, is found to approach 1000 ml/min for the FX60 with a surface of only 1.4 m(2). Local clearance measurement shows equal performance of the Helixone fibre bundle over the entire cross-section. A dialysate flow reduction by 20% (in vivo) only results in a minor loss in clearance. CONCLUSIONS: The newly developed high-flux dialyzer (FX60) shows a remarkable performance (K(0)A(urea)). The excellent utilization of dialysate could be proven in vivo and is attributed to the superior dialysate flow distribution. A reduction of dialysate flow by 20% could lead to substantial economic savings.     

空心纤维型透析器复用疗效的临床观察

目的：探讨空心纤维型透析器复用的有效次数肯定其应用价值。方法：再生后透析器经判定符合标准者方能重复使用。每次血透前后留取血标本进行BUN、Cr、UA等项测定。统计学处理采用t检验或秩和检验。结果：新透析器及各次复用透析器血透前后血BUN、Cr、UA等均值比较有显著性差异（P＜0．01）；复用后至8次以上只有血BUN、Cr的排除率及CO2CP上升率与新透析器比较时才有显著性差异（P均＜0．05）。结论：空心纤维透析器复用以8次为合适，最多不能超过10次。     

不同透析膜对维持性血液透析患者B细胞活化的影响

目的　观察尿毒症患者反映B细胞活化的血清sCD2 3 浓度水平的变化及不同种类透析膜对维持性血液透析患者血清sCD2 3 水平的影响。方法　采用双抗体夹心ELISA法检测尿毒症非透析患者 ,及使用不同种类透析膜透析器初用及复用 5次时分别观察透析过程中患者血清sCD2 3 水平的变化。结果　尿毒症血液透析患者透析前及尿毒症非透析患者血清sCD2 3 较正常对照组显著增高。血透过程中尿毒症血透患者血清sCD2 3 分子浓度水平规律性的变化。不同类型透析膜中 ,醋酸纤维素膜 (CA)对血清sCD2 3 的影响显著大于血仿膜 (HE)和聚砜膜 (PS) ;透析器复用对血透患者血清sCD2 3 水平无明显影响。结论　血透过程中血清sCD2 3 分子浓度水平规律性的变化 ,是导致机体免疫力下降的可能原因之一。HE膜和PS膜生物相容性优于CA膜 ,透析器复用可改善透析膜的生物相容性     

不同透析膜对凝血纤溶功能的影响

为观察透析过程中不同透析膜对凝血纤溶作用的影响 ,对 1 2例维持性血液透析患者采用交叉设计 ,使用铜仿膜和聚砜膜透析器透析 ,应用ELISA法检测透析过程中凝血酶 抗凝血酶Ⅲ复合物 (TAT)、纤溶酶 α2抗纤溶酶复合物 (PAP)、D 二聚体的动态变化 ,并用扫描电镜观察透析后透析器表面凝血情况。结果显示 ,用 2种透析膜血透过程中TAT、PAP、D 二聚体均显著高于透析前水平 ,用铜仿膜透析TAT、PAP、D 二聚体均显著高于用聚砜膜。提示 ,从凝血纤溶激活看 ,聚砜膜生物相容性好于铜仿膜 ,长期使用生物相容性好的透析器可能会减少出凝血并发症。     

Topological,Mechanical and Biological Properties of Ti6Al4V Scaffolds for Bone Tissue Regeneration Fabricated with Reused Powders via Electron Beam Melting

Cellularized scaffold is emerging as the preferred solution for tissue regeneration and restoration of damaged functionalities. However, the high cost of preclinical studies creates a gap between investigation and the device market for the biomedical industry. In this work, bone-tailored scaffolds based on the Ti6Al4V alloy manufactured by electron beam melting (EBM) technology with reused powder were investigated, aiming to overcome issues connected to the high cost of preclinical studies. Two different elementary unit cell scaffold geometries, namely diamond (DO) and rhombic dodecahedron (RD), were adopted, while surface functionalization was performed by coating scaffolds with single layers of polycaprolactone (PCL) or with mixture of polycaprolactone and 20 wt.% hydroxyapatite (PCL/HA). The mechanical and biological performances of the produced scaffolds were investigated, and the results were compared to software simulation and experimental evidence available in literature. Good mechanical properties and a favorable environment for cell growth were obtained for all combinations of scaffold geometry and surface functionalization. In conclusion, powder recycling provides a viable practice for the biomedical industry to strongly reduce preclinical costs without altering biomechanical performance.     

可重复使用透析器外壳消毒的有效性

［摘要］目的了解可重复使用透析器外壳细菌污染情况及两种不同消毒方法的消毒效果。方法将使用后的复用透析器经过全自动复用消毒机清洗、检测、消毒后,放入储存柜存放前,于不消毒、采用含有效氯500 mg/L消毒剂擦拭和浸泡消毒两种方式进行表面消毒后采样检测。结果3组各100支灌满消毒液的复用透析器外壳细菌检测结果：未消毒组细菌菌落数平均为（15.52±3.81）CFU/cm2,合格率为87%;采用含有效氯500 mg/L消毒剂擦拭消毒组细菌菌落数平均为（3.22±0.71） CFU/cm2,合格率100%;浸泡在有效氯浓度为500 mg/L消毒剂内10 min组则未检出细菌,合格率100%。两消毒组与未消毒组合格率比较,差异均有统计学意义（χ2=7.89,P＜0.05）。结论灌满消毒液的复用透析器外壳采用含有效氯500 mg/L消毒剂擦拭或将复用透析器整体浸泡在上述浓度的消毒剂内10 min,均能达到消毒要求,但后一种方法消毒灭菌效果更佳。     

复用透析器预充效果与预充技术相关因素研究

目的减少复用透析器中的甲醛含量 ,降低病人费用。方法选择内循环时间 (因素A)、0 9%氯化钠溶液(NS)预充量 (因素B)、血泵流速 (因素C) 3个因素 ,各因素取 3个水平 (第 1水平为因素A 10min、因素B 10 0 0ml、因素C 2 0 0ml/min ;第 2水平为因素A 2 0min、因素B 15 0 0ml、因素C 30 0ml/min ;第 3水平为因素A 30min、因素B2 0 0 0ml、因素C 4 0 0ml/min) ,分别预充经 4 %甲醛消毒后的复用透析器 ,用低含量甲醛检测盒测试甲醛残留量。结果甲醛残留量 (μg/ml)第 1水平 3个因素分别为 1 30± 1 32、1 2 7± 1 34、1 34± 1 30 ;第 2水平分别为 0 84± 0 2 0、0 71± 0 2 0、0 79± 0 2 0 ;第 3水平分别为 0 71± 0 2 0、0 88± 0 15、0 72± 0 2 1。第 1与第 2、3水平间比较 ,均P <0 0 1,第 2与第 3水平间比较 ,P >0 0 5。结论预充中各因素均选取第 2水平即内循环时间 2 0min ,NS预充量 15 0 0ml,血泵流速 30 0ml/min为最佳配伍     

血液透析类产品临床试验设计要点

血液净化疗法是指应用物理、化学或免疫学等方法清除体内过多的水分及血中代谢废物、毒物、自身抗体、免疫复合物等致病物质,以维持体内水、电解质和酸碱平衡的治疗方法。血液透析作为血液净化疗法的一种,是针对慢性肾衰竭的主要治疗手段之一。近年来随着透析治疗技术的发展,国产透析机、透析器等器械的注册申报数量也越来越多,文章拟对血液透析治疗中几类主要医疗器械的临床试验设计展开探讨,以供同行参考交流。