透析器复用灭菌灌注方法的改进

目的减少透析器复用中灭菌剂伦拿连的浪费,降低灭菌剂的消耗和成本。方法对透析器复用灭菌灌注方法进行改良,采用改良灌注法和传统灌注法分别对100套血路管、透析器进行灌注,观察两组灭菌效果、所消耗灭菌剂用量和时间。结果改良灌注组和传统灌注组均无热原反应发生。改良灌注组消耗灭菌剂为(312.00±7.00)ml,灌注时间为(3.12±0.07)min,灭菌剂成本为(1.75±0.04)元;传统灌注组消耗灭菌剂为(957.00±40.00)ml,灌注时间为(6.16±0.13)min,灭菌剂成本为(5.60±0.14)元。两种灌注法消耗灭菌剂量、时间和成本有显著性差异(P均=0.001)。结论改良灌注组能保证灭菌效果,减少灭菌剂伦拿连浪费,降低成本及提高工作效率。     

Immobilizing argatroban and mPEG-NH2 on a polyethersulfone membrane surface to prepare an effective nonthrombogenic biointerface

Systemic anticoagulation is not suitable for hemodialysis (HD) patients with a high risk of bleeding in the clinic. An HD membrane that provides a localized anticoagulation membrane surface may be a promising strategy to solve this intractable problem for HD patients. Herein, we modified a nonthrombogenic polyethersulfone (PES) dialyzer membrane by grafting argatroban (AG) and methoxy polyethylene glycol amine (mPEG-NH₂) via a polydopamine (PDA) strategy. The PES substrates were immersed in an alkaline dopamine solution for 24?h, and then, AG and mPEG-NH₂ were sequentially grafted covalently onto the resultant membrane. Attenuated total reflection-Fourier transform infrared spectroscopy (ATR-FTIR) and X-ray photoelectron spectroscopy (XPS) were utilized to confirm the successful introduction of PDA and the immobilization of AG and mPEG-NH₂. Scanning electron microscopy (SEM) and atomic force microscopy (AFM) were used to observe the surface structure and morphology after the surface modification. The excellent antithrombotic abilities of the modified membrane were demonstrated by the suppression of platelet adhesion and activation, prolongation of clotting times, and inhibition of thrombin generation and complement activation. This work describes an efficient and convenient method to immobilize AG and mPEG-NH₂ to create a nonthrombogenic biointerface for blood-contacting devices such as HD membranes.     

ZOEY16L聚醚砜透析器对维持性血液透析患者的疗效和安全性的随机对照试验

目的 探讨ZOEY16L聚醚砜透析器对维持性血液透析(MHD)患者小分子毒素的清除效果,并观察其临床应用安全性。方法 选取宜宾市第二人民医院肾脏内科血液净化中心74例MHD患者为研究对象,采用随机、开放、平行对照试验方法,纳入者分为观察组和对照组,每组37例。比较观察组（ZOEY16L）和对照组（PES16LF）透析器对尿素氮、肌酐等指标的清除效果;同时分析两组透析前后外周血血红蛋白、白蛋白等安全性指标差异,记录不良事件发生情况,观察试验器械的临床疗效和安全性。 结果 两组临床基线资料比较差异无统计学意义（P＞0.05）,60 min肌酐清除率观察组与对照组比较,差异有统计学意义（P＜0.05）;两组间尿素氮清除率、尿素氮及血磷下降率、超滤率、spKt/V差异均无统计学意义（均P＞0.05）;两组治疗前后安全性指标差异无统计学意义（P＞0.05）,无严重不良反应。 结论 ZOEY16L与PES16LF对尿毒症小分子毒素的清除作用相当,ZOEY16L聚醚砜透析器临床应用安全有效。     

日机装DBB27型血透机的维修

对DBB27血透机经常出现的负压报警、静脉端微小气泡报警和减压阀故障案例进行分析,与维修实验,排除了故障。提出平时的保养工作的针对性与方法,减少了设备故障率。     

可追溯性的透析器质量控制

目的建立透析器使用全过程质量控制管理体系，并通过金字塔模型对质量问题进行管控分析，以监测不良反应，为透析器质量管理打下坚实的基础。方法使用透析器条码和透析管理软件对每个透析器进行编码。收集上海市2家血液净化中一~2012年6月～2013年2月透析器使用情况数据，建立单次治疗中单个病人透析器使用过程的点对点的关联体系，从而实现透析器的可追溯管理。结果利用金字塔型数据模型，通过多维度分析，对质量问题进行归类。结论透析器质量管理体系的实施，实现了透析器的可追溯管理。     

Evaluation of dialyzer jacket structure and hollow-fiber dialysis membranes to achieve high dialysis performance

The objective of this study was to determine the optimum dialyzer jacket structure and hollow-fiber dialysis membrane, both of which are indispensable factors for achieving high dialysis performance, by clarifying the relationship between the dialysis performance and the flow of dialysate and blood in a hollow-fiber dialyzer. We evaluated the clearance, dialysate, and blood flow for four commercially available hollow-fiber dialyzers, namely, the APS-15S, APS-15SA, TS-1.6UL, and CX-1.6U. To evaluate dialysate and blood flow, we measured the residence-time distribution of dialysate and blood flow of these dialyzers by the pulse-response method. We also determined the clearances of urea, creatinine, vitamin B(12), and lysozyme to evaluate the dialysis performance of these dialyzers. While the baffle and taper structures allow effective supply of dialysate into the dialyzer jacket, the hollow-fiber shape, inner diameter, and packing density significantly influence the dialysate flow. In dialyzers with long taper-holding slits, the slit area is a key design parameter for achieving optimum dialysate flow. Similarly, the blood flow is significantly influenced by the structure of the inflowing and outflowing blood ports at the header of a dialyzer, and the shape and inner diameter of the hollow fibers. Hollow fibers with smaller inner diameters cause an increase in blood pressure, which causes blood to enter the hollow fibers more easily. The hollow-fiber shape hardly affects the blood flow. While improved dialysate and blood flow cause higher clearance of low molecular-weight substances, higher membrane area and pure-water permeability accelerate internal filtration, thereby causing an increase in the clearance of large molecular-weight substances.     

以FX60透析器行血液透析患者氨基末端钠尿肽水平变化及其影响因素

目的探讨以FX60透析器行血液透析患者氨基末端钠尿肽（NT—proBNP）水平变化及其影响因素。方法选择透析龄〉2年的血液透析患者30例,以FX60透析器透析1年,观察患者高通量透析前后血压、血红蛋白、白蛋白、血钙、血磷、钙磷乘积、甲状旁腺素（iPTH）、尿素清除指数（Kt／V）、β2-微球蛋白（β2-MG）、左心室射血分数（LVEF）和氨基末端钠尿肽的变化,多因素分析患者血浆氨基末端钠尿肽的相关影响因素。结果（1）患者Kt／V为1．45±0．38,超滤量为（3．29±0．69）kg,平均动脉压（104．5±7．3）mmHg,血红蛋白由（103．9±18．1）g／L升至（111．8±11．5）g／L,iPTH由（525．2±695．6）ug／L降至（437．3±417．2）ug/L,LVEF由（60．0±7．3）％升至（64．3±8．7）％;（2）单次高通量透析前血浆氨基末端钠尿肽水平为（6724±8721）ug/L,透析后为（5268±4276）ug／L,降低（29．6±3．2）％,β2-微球蛋白清除率为（35．9±3．8）％;（3）多因素分析显示氨基末端钠尿肽与超滤量、平均动脉压无相关性,与LVEF呈负相关（P〈0．05）,相关系数为-0．650（95％可信区间7147～17892ug/L）。结论血液透析患者透析前、透析后血浆氨基末端钠尿肽普遍增高,与超滤量、血压无相关性,与LVEF呈负相关,氨基末端钠尿肽可预测血液透析患者的左心室功能;以FX60透析器行高通量透析可改善患者的并发症,降低氨基末端钠尿肽水平。     

血液透析二级反渗透水处理系统的安装与维护

水处理系统是为保障血液透析机正常运行而提供符合透析用水的装置。本文主要介绍了用于血液透析用水的二级反渗透水处理系统的功能、设备配置、安装、维护，以提供≥30床血透机的用水量为例。     

Bacteria and endotoxin removal from bicarbonate dialysis fluids for use in conventional, high-efficiency, and high-flux hemodialysis

The use of bicarbonate-based dialysis fluids in hemodialysis centers in the United States has increased with the advent of high-efficiency and high-flux hemodialysis. However, bicarbonate dialysis fluids can support rapid bacterial growth and high endotoxin concentrations. This study determined the efficacy of an ultrafiltration device in reducing the bacterial and endotoxin concentrations in bicarbonate dialysis fluids. A polysulfone hollow fiber dialyzer was used to ultrafilter bicarbonate concentrate before entering the central proportioner and bicarbonate dialysate after exiting the proportioner in single patient dialysis machines. Pre- and post-ultrafilter samples were collected for bacterial and endotoxin assays over 10 months. Ultrafiltration of bicarbonate concentrate reduced bacterial and endotoxin concentrations from 288,330 colony forming units (CFU)/ml and 42,804 pg/ml to 0.47 CFU/ml and 109 pg/ml, respectively. Ultrafiltration of the dialysate in single patient systems decreased bacterial and endotoxin concentrations from 15,889 CFU/ml and 1,746 pg/ml to 0.003 CFU/ml and 0.109 pg/ml, respectively. These results demonstrate that ultrafiltration of bicarbonate dialysis fluids is effective in reducing bacterial and endotoxin contamination inherently associated with the use of bicarbonate-based dialysates.     

Computer-aided design of hollow-fiber dialyzers

Blood and dialysate flow patterns in hollow-fiber dialyzers are complicated, and hence the flow patterns and mass transfer are difficult to analyze theoretically. Consequently, dialyzers are usually developed by a trial-and-error method. We attempt to design dialyzers by computer simulation analysis in this work. Blood-side and dialysate-side flows were modeled using the Hagen-Poiseuille equation and the Blake-Kozeny equation, respectively. These flow patterns were evaluated as pressure drop and velocity distribution. The mass transfer rate was evaluated as solute clearance. Computed values of the pressure drops and clearance for urea and vitamin B₁₂ were found to agree closely with those obtained experimentally. We evaluated the influences of the inner diameter of hollow fibers, module geometry, and void fraction on the pressure drop and clearance, and computer-aided design was performed.