复用透析器消毒剂清除方法的对比观察

目的探讨安全、经济、实用的复用透析器消毒剂的清除方法,以达到理想的消毒剂残余浓度。方法选择本中心16例慢性肾功能衰竭维持性血液透析患者,使用可复用透析器进行透析。实验组采用闭路循环方法,对照组采用放液一冲洗一循环的方法,对复用后透析器的消毒剂进行清洗。使用Renalin残余量测试条检测透析器的消毒剂残余浓度,并观察患者透析中的反应。结果实验组消毒剂残余量均~3ppm,符合规定的标准,与对照组比较无显著性差异（P〉0．05）。无1例患者在透析过程中出现恶心、呕吐、发热、低血压等反应。结论采取闭路循环清除消毒剂的方法,可以使消毒剂从透析器旁路随着加温的透析液得到持续彻底的清除,该方法安全、经济、实用。     

Migration of Acetylated Hemicellulose from Capillary Hemodialyzer to Blood, Causing Scleritis and/or Iritis

From November 1981 to early March 1982, an outbreak of scleritis and/or iritis occurred among patients treated with a Nipro brand NAC series cellulose acetate capillary dialyzer. The rate of incidence with dialyzers produced in 1982 was significantly higher than that with dialyzers produced in 1981. An extract obtained from the dialyzers caused iritis in rabbits after its infusion into an auricula vein. Glycerol, acetylated carbohydrate (AC) derivatives, urethane derivatives, and polypropyleneglycol were found in the extract. AC derivatives caused iritis in rabbits, whereas they caused hyperemia of the bulbar conjunctiva in dogs. The AC derivatives contained xylose and glucose units in a ratio of 1.6-2.3:1. The amounts of AC derivatives were significantly larger in the extracts from 1982 than from 1981 devices. Moreover, another brand, but the same type, of dialyzer, the Cordis Dow 4000, contained a slight amount of them. These facts show that AC derivatives derived from hemicellulose played a primary role in the outbreak.     

贝朗Dialog血液透析机的质量控制

充分利用好血液透析机的关键是建立起完备的参数质控程序。本文以贝朗Dialog血液透析机为例，介绍了对各项技术参数的检测和定标校正：包括电导度、温度、超率量、血流量及肝素注入量。     

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。     

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.     

Improving Hollow Fiber Dialyzer Efficiency with a Recirculating Dialysate System II: Comparison Against Two-Chamber Dialysis Systems

The theoretical basis of the nonregenerated recirculating dialysate system (RDS) was derived in Part I of this work [M. Prado, L. M. Roa, A. Palma, and J. A. Milán, Ann. Biomed. Eng. (2005)]. This system pursues the maximization of the clearance of hollow fiber dialyzers whose performance is controlled by diffusion, as occurred in standard hemodialysis. In this second part we perform a comparison by digital simulation of the RDS against three well-known two-chamber dialysis systems. As a major outcome, the efficiency of the RDS increased by a factor of five–eight with respect to the efficiency of a single dialyzer operating with a number of transfer units equal to 0.1, that is when the diffusive mass-transfer of the dialyzer is exhausted. Present low-flux dialyzers do not take advantage of the full potential of this technique, but the functional domain where high-flux and high-area dialyzers operate could be more suitable to exploit this technique. We conclude that RDS can be a competitive efficient technique for optimizing the dialysis efficiency.     

Characterization of insulin adsorption behavior of dialyzer membranes used in hemodialysis

Although it has been reported that plasma insulin is removed by hemodialysis (HD), the mechanism for this has not been elucidated. We investigated the mechanism of insulin removal during HD treatment and the characteristics of insulin removal with three high-flux membranes. In our in vivo study, 20 stable diabetic patients on HD were randomly selected for three HD sessions with three different membranes: polysulfone (PS), cellulose triacetate (CTA), and polyester polymer alloy (PEPA). Blood samples were obtained from the blood tubing at the arterial (A) site at the beginning and end of the sixth HD session to investigate insulin reduction in patients. At 1 h after the initiation of dialysis, blood samples were obtained from both the A and venous sites of the dialyzer to investigate the insulin clearance with the different membranes. There was a significant reduction in patients' plasma insulin at each time point with each of the three membranes. The insulin clearance with the PS membrane was significantly higher than that with the CTA and PEPA membranes. Although no difference was observed in the plasma insulin reduction rate between the three membranes in the total subject group, there was a significantly higher reduction rate with the PS membrane in insulin-dependent diabetes mellitus subjects. The clearance of insulin in in vitro tests was significantly higher with the PS and PEPA membranes than with the CTA membrane in both new and clinically used dialyzers. Insulin was not detected in the dialysate or ultrafiltration fluids in either the in vivo or in vitro studies. The mechanism of plasma insulin clearance by HD is mainly by adsorption, and the amount of insulin adsorbed differed depending on the dialyzer membrane used.     

中空纤维透析器内的浮力对流及其存在条件

中空纤维管透析器是人工血液透析等设备的质交换部件,其内部流体的浓度会发生变化,一般认为密集分布的纤维管能抑制管间流体的浮力作用.通过三维数值模拟,研究中空纤维透析器内流体在重力场中的流动,探讨浮力对流的存在条件及其对透析的影响.计算基于双多孔介质模型,纤维膜传质采用K-K方程描述,用计算流体软件FLUENT进行数值求解.结果表明,抑制浮力引起的对流并不是无条件的,需要综合考虑纤维管填充密度、血液入口浓度和透析液入口流量等因素.当纤维管分布密度低于临界值时,浮力作用是显著的;当高于临界值时,浮力作用是可以忽略的.该临界值与透析液流量和溶质浓度有关.本研究对于分析中空纤维透析器的透析传质过程具有理论意义.     

REXEEDTM系列高通量透析器疗效和安全性的临床随机对照试验

目的 评价REXEEDTM系列高通量透析器的疗效和安全性。 方法 研究对象为上海两家医院规律性血液透析（血透）患者72例。采用随机化交叉设计,采用REXEEDTM不同膜面积（1.5 m2和2.1 m2）15AC、15UC、21AC、21UC透析器（试验组）以及APS-15U、BIO-HX100透析器（对照组）,分别按2个3×3拉丁方进行透析治疗。检测透析器尿素、肌酐、磷、β2微球蛋白清除率,尿素、肌酐下降比率及治疗前后安全性指标。观察及记录不良反应。 结果 试验组15AC、15UC透析器的尿素、肌酐清除率均显著大于对照组APS-15U[分别为（222.07±18.74） ml/min、（220.23±26.26） ml/min比（199.56±14.21） ml/min;（176.73±16.41） ml/min、（175.22±25.94） ml/min比 （165.42±14.68） ml/min,均P < 0.05]。两组间磷和β2微球蛋白清除率差异均无统计学意义。21AC、21UC透析器尿素、肌酐、β2微球蛋白清除率均显著大于对照组BIO-HX100[分别为（230.59±15.24） ml/min、（233.96±7.06） ml/min比（203.43±36.66） ml/min;（183.50±25.90） ml/min、（181.05±23.94） ml/min比（166.25±29.82） ml/min;（111.77±53.42） ml/min、（125.54±51.99） ml/min比（42.39±4.81） ml/min,均P < 0.05]。两组间磷清除率差异无统计学意义。试验组4种透析器尿素下降比率均大于89%,治疗前后安全性监测指标均无明显变化。不良反应和不良事件少而程度轻,无严重不良反应。 结论 REXEEDTM-AC、UC系列高通量透析器临床使用安全有效。