中空纤维透析器清除率与血液流率关系研究

中空纤维透析器是血液净化透析治疗中的重要组成部分,而超滤率和清除率是评价透析器治疗效果的两大性能指标。本文使用膜面积相等、同为高通量的三种不同材料透析器（三醋酸纤维透析器、聚醚砜透析器与聚砜透析器）作为实验材料,测试并比较三种材料透析器对小分子代表物质（尿素、肌酐）和中分子代表物质（磷酸盐、维生素B,2）的清除率,以及血液流率与清除率之间的相关关系,以期对透析器的临床使用及国内透析器制备行业的发展等提供参考性建议。     

台式血压计在血液透析器血室压力检测中的应用

血液透析是将血液引出体外,在透析器内与透析液之间进行物质交换,排出体内废物以及过多的水分,然后再将血液回输至体内的过程,透析过程中血液与透析液在透析器呈反向流动,溶质(毒素)和水的跨膜均在透析器中进行,透析膜是透析器的主要组成部分,透析膜是由8000～15 000条中空纤维组成,纤维内径为200 μm,壁厚约10 μm,血液在中空纤维管中流动,这些中空纤维称为血室,血室的压力下降<0.83 mm Hg/s时,不能复用.     

不同透析膜材料透析器对透析过程中颈动脉-股骨头距离动脉脉冲速率的影响

目的 分析不同透析膜材料透析器对透析过程中动脉弹性的影响.方法 分别使用两种不同透析膜材料透析器(三醋酸纤维膜或聚砜膜)进行血液透析,透析前、透析过程中及透析后分别检测颈动脉-股骨头距离动脉脉冲速率(PWV)值,并进一步分析透析过程中体重增加小于1 kg患者透析过程和单纯超滤过程两种透析膜材料透析器对动脉PWV值的影响.结果 使用聚砜膜透析器时,动脉PWV值相对较低,在透析75min时下降14%,135min时下降16%(P<0.05);对11例患者(透析过程中体重增加小于1 kg)使用三醋酸纤维膜透析器,动脉PWV值持续显著性增高,在75 min时达到最大(增加40%)(P<0.01).使用三醋酸纤维膜透析器,透析前动脉PWV值与透析过程中动脉PWV值的变化存在显著负相关性(r=-0.60,P<0.01).对随机选取的9例患者单纯超滤1 h,透析膜只有血液灌注而无传质过程时,使用三醋酸纤维膜透析器患者动脉PWV值显著增高(P<0.01),而使用聚砜膜透析器患者动脉PWV值无明显变化.结论 三醋酸纤维膜透析器透析时能迅速改变动脉弹性,可能与透析器膜材料生物不相容性有关.     

空心纤维透析器进展和评价

本文介绍了空心纤维透析器的进展情况,重点对铜仿膜、血仿膜、聚砜膜透析器的结构及特点加以比较,以适应不同病人的需要。     

中空纤维膜式氧合器的研究进展

在论述中空纤维结构和材料的基础上,阐述了中空纤维膜氧合器近年来在ECMO和ITAL方面的发展状况,针对不同类型的氧合器,详细介绍了为提高气体交换性能和生物相容性,在膜材料改进的途径和结构设计上的优化方案,明确了中空纤维膜氧合器的研究内容,并对未来的研究方向提出了自己的看法。     

床边血液净化治疗高通量透析器局部凝血分析与应对

目的是危重症患者行床边高通量血液净化时无肝素[1]化情况下出现透析器局部凝血(半凝血),凝血的纤维膜占全透析器的1/2～2/3部分,并局限在透析液出入口侧,对侧纤维膜凝血不明显现象,对此现象进行分析,采取应对措施。方法我们对20例床边无肝素高通量净化对照病例进行研究,观察到半凝血现象。采用20例实验相似病例倾斜透析器的方法,使透析器倾斜45°角进行对比。结果透析开始1h冲管观察透析器半凝血现象减轻,透析器使用时间延长,血肌酐清除率增加。     

扁平型空心纤维透析器

目前使用的园柱形空心纤维人工肾透析器中的透析膜尚未充分利用,这是由于纤维束周国的透析液分布不匀造成的,这使透析器的实际效率比理论估算值大为减低。为消除这一弊病,日本东京医科、齿科大学医学系研制了扁平型空心纤维透析器,并在体内体外进行了试验。他们把这种透析器与西德恩卡公司生产的铜仿膜空心纤维透析器(纤维壁厚16μ)作比较,在同样1平方米的面积时,扁平型纤维束对尿素、肌     

跨膜压对空心纤维透析器超滤率体外检测的影响

目的探讨跨膜压对空心纤维透析器超滤率体外检测的影响。方法选用四种规格的空心纤维透析器,按跨膜压从小到大的顺序测量超滤率的值,并进行比较分析。结果随着跨膜压的增大,高通量透析器（膜面积2.1m2）的超滤率下降幅度为53.0ml/mmHg/hr,高通量透析器（膜面积1.5m2）的下降幅度为40.2ml/mmHg/hr,低通量透析器（膜面积2.1m2）的下降幅度为6.4ml/mmHg/hr,低通量透析器（膜面积1.3m2）的下降幅度为3.1ml/mmHg/hr。结论跨膜压的增大会使超滤率体外检测结果出现不同程度的下降。     

超滤法去除细菌内毒素

利用聚砜为膜材料 ,通过相转化法制成外压式聚砜中空纤维超滤膜 ,制成的中空纤维超滤器(φ90mm× 5 0 0mm) ,水通量大于 15 0L h·atm ,截留分子量在 6 0 0 0左右 ,可去除细菌内毒素 ,达到药典规定的指标。文中介绍了热原本质、定量表示及测定方法 ;介绍了外压式中空纤维超滤装置在药液除热原工艺中的使用情况 ,并提出在运用时应注意的问题。     

氧化电解水复用透析器的应用探讨

使用化学消毒药剂复用透析器，易腐蚀透析器纤维膜使其老化、复用效率低，化学消毒药剂冲洗净能引起医源性的抗体损伤。我们把氧化电解水作血液透析器的复用剂，能最大限度地减少透析器功能的退化。     

血液透析期间中性粒细胞动力学和功能监测

目的　评价血透期间不同透析膜对中性粒细胞 (PMN)动力学和功能的影响。方法　采用铜仿膜、醋酸纤维膜、双醋酸纤维膜、聚砜膜和聚乙烯醇膜透析器 ,测定透析前、透析 15、 30、 6 0分钟和透析结束时PMN数量 ,并在铜仿膜和复用铜仿膜透析前后测定PMN趋化、吞噬和杀菌功能以及透析症状发生率。结果　不同透析膜透析 15分钟时PMN均有下降 ,其中以铜仿膜组最为显著 (P <0 0 1) ,铜仿膜复用后PMN下降明显减轻 ;透析患者的PMN趋化、吞噬功能低于正常 (P <0 0 1) ,杀菌功能正常 ,铜仿膜透析后PMN趋化、吞噬功能明显损害 ,铜仿膜复用后PMN功能改善 ;复用铜仿膜透析期间患者症状和并发症发生率明显低于使用新透析膜者。结论　透析期间PMN动力学监测是评价膜生物相容性的简便指标 ,透析膜的非相容性影响PMN动力学和功能以及透析症状的发生。     

Experimental Design and Clinical Observation of Modialysis Apparatus

Objective To evaluate the clinical safety and efficacy of polyethersulfone membrane hollow fiber dialyzer Enttex~(TM)-16LF(E60)in treating patients with end stage renal disease caused by a variety of reasons.Methods This clinical trialwas designed as a randomized,open,two-phase crossover and positive control,non-inferiority study.To evaluate the indicators of blood routine test,serum biochemical indexes,blood gas analysis,vital signsbefore and after hemodialysis,and the adverse events were recorded indetail.Results There was no significant difference in creatinine,urea,creatinine clearance and electrolytes between Enttex TM-16LF dialyzer and control dialyzer before and after hemodialysis,no adverse event associated with the Enttex~(TM)-16LF dialyzer was found during the study.Conclusions The Enttex~(TM)-16LF dialyzeris effective and safe for hemodialysis in patients with end stage renal disease.     

Clinical Application of PES Membrane Dialyzer

Objective The dialysate membrane can be classified into acetate membrane and synthetic membrane,while the latter can be further divided into polysulfone,polyacrylonitrile,etc.Polyethersulfone membrane is high molecular membrane material with excellent biocompatibility,stable mechanical properties,high temperature and pressure resistance,and good cleaning performance,which has been applied for more than 10 years.This trial is to assess the safety and efficacy of hollow polysulfone membrane fiber dialyzer with pattern number Enttex~(TM)-16LF (E60) for hemodialysis in patients with acute or chronic renal failure due to multiple factors.Methods Totally 76 patients receiving maintenance hemodialysis were included in a two-site,random,open label,two-stage,positive crossover and non inferiority validation study.The clinical efficacy and safety of the test device were observed,which was a hollow fiber dialyzer produced by Guangzhou Enttex Medical Products Co.,Ltd.,with polyethersulfone membrane imported from Germany.It was a low flux dialyzer with the pattern number of EnttexTM-16LF (E60).Inclusion criteria:①patients with acute or chronic renal failure due to various reasons who needed hemodialysis;②18 to 80 years old,gender unlimited;③patients who received stable dialysis for more than 3 months,regular hemodialysis 3 times a week,4 h at each time,blood flow rate of 200～350ml/min;④using bicarbonate dialysate at a flow rate of 500ml/min;⑤patients with arteriovenous fistula or who received artificial blood vessel puncture dialysis;received anticoagulation by heparin or low molecular weight heparin.Exclusion criteria:①patients needing heparin free dialysis for severe anemia,tumor and active bleeding;②patients with severe cardiac (gradeⅢcardiac function),hepatic (severe hepatitis and cirrhosis) and pulmonary diseases (severe respiratory failure).Results Comparison of parameters,including the changes of Kt/V,general creatinine and urea clearance rates and URR (urea reduction rate) shows no statistical significance in differences between the two devices,indicating that the test and control devices can equally and effectively eliminate toxins including creatinine and urea,etc.PPP and MITTP results are consistent.Comparison of ultrafiltration rates between two groups of patients shows no statistical difference.PPP and MITTP results are consistent,indicating that both the test device and control device can effectively eliminate water.In MITTP,electrolytes including K~+,Na~+,Cl~-,Ca~(2+),HCO_3~-,etc.show no statistical significance in difference between the test and control devices before and after dialysis (P>0.05).After treating by using test and control devices,body weight,serum potassium and phos-phorus all significantly decrease (P<0.001);serum Ca~(2+),PO_2,PCO_2and HCO_3~-all significantly increase (P <0.001).These results indicate that both the test and control devices can effectively eliminate serum potassium and phosphorus,and eliminate excess water in body,maintain the balance between liquid and electrolytes in patients.PPP and MITTP results are consistent.Conclusion This clinical trial confirms that hollow polyethersulfone membrane fiber dialyzer can be safely and effectively used in hemodialysis therapy.     

Bacterial contamination of dialysate in dialysis-associated endotoxaemia

Bacteriological investigations and endotoxin (ET) determinations were performed during a routine haemodialysis session for six patients. The glucose free dialysate was prepared with untreated tap water. All patients were dialysed for 5 h. Pseudomonas aeruginosa was regularly isolated in numbers up to 10(7) cfu ml-1 from samples of the dialysate inflow, the dialysate site and the dialysate outflow. ET levels in the plasma of the patients increased continuously during haemodialysis and were always higher in the blood outflow line of the dialyzer than in the blood inflow. Despite the high bacterial counts in the dialysate and the increasing ET levels in the patients plasma neither bacteraemia nor fever was observed. The former is due to the impermeability of the dialyzer membrane for bacteria, the latter is explained by low pyrogenicity of P. aeruginosa endotoxin. Inspection of the dialyzer machines revealed that air-traps and heater-unit for the incoming (untreated) tap water before mixing with the dialysate concentrate were the only sites where high bacterial release was feasible, as this part of the machine escaped disinfection due to the construction of these devices. We recommend the regular disinfection of all parts of a dialyzer machine, including heating units, air traps and valves.     

血液透析器的生物相容性研究及其临床应用现状

目前血液透析器已广泛应用于临床,透析器的核心部分为透析膜,透析膜的生物相容性及其生物学评价成为当今的研究热点。本文就血液透析器的膜材料、透析膜的生物相容性及其生物学评价和透析器的临床应用现状作一综述。     

透析器重复使用的临床评价

目的探讨透析器重复使用对患者的治疗费用、潜在风险及复用成本的影响。方法将178例血液透析患者按透析器使用次数分为单次使用组(n=94)和复用组(n=84),观察两组患者治疗费用、不良事件及透析器复用所需成本。结果单次使用组接受低通量血液透析(LFHD)8750例次和高通量血液透析(HFHD)653例次,费用分别为(565.46±4.82)元/次和(809.12±10.39)元/次,透析器复用组接受LFHD3840例次和HFHD4660例次,费用为(475.74±3.61)元/次和(529.57±10.55)元/次,两组均未见热原反应、透析器破膜和灭菌剂残余反应发生,未发现新增感染肝炎病例。采用全自动和半自动复用方式进行透析器复用,其复用时间和灭菌剂成本分别为(9.03±0.67)、(23.97±1.18)分钟/支和(9.20±0.14)、(2.01±0.23)元/支。结论复用组HFHD治疗费用明显低于单次使用组LFHD;而按规范进行透析器复用可有效避免风险发生。     

JMS SDS-20血液透析机水路流程分析

本文详细分析了JMS SDS-20血液透析机水路流程,充分说明了各个元器件的工作状态、作用及有关参数。     

Association of dialyzer reuse with hospitalization and survival rates among U.S. hemodialysis patients: do comorbidities matter?

The objective of this study was to determine whether the associations between reuse of hemodialyzers and higher rates of death and hospitalization persist after adjustment for comorbidity. This was a nonconcurrent cohort study of survival and hospitalization rates among 1491 U.S. chronic hemodialysis patients beginning treatment in 1986 and 1987. The impact of dialyzer reuse was compared across three survival models: an unadjusted model, a "base" model adjusted only for demographics and renal diagnosis, and an "augmented" model additionally adjusted for comorbidities. We found that reuse of dialyzers was associated with a similarly higher rate of death in analyses unadjusted for confounders (relative risk [RR] 1.25, 95% confidence interval [CI] 0.97-1.61), adjusted for demographics and renal diagnosis (RR 1.16, 95% CI 0.96-1.41), and analyses additionally adjusted for comorbidities (RR = 1.25, CI, 1.03, 1.52). Reusing dialyzers was also associated with a greater rate of hospitalization that was stable regardless of adjustment procedures. We conclude that higher rates of death and hospitalization associated with dialyzer reuse persist regardless of adjustment for demographic characteristics or baseline comorbidities. These findings amplify concerns that there exists elevated morbidity among hemodialysis patients treated in facilities that reuse hemodialyzers. Although the association we observed was not confounded by comorbidity, a cause-and-effect relationship between dialyzer reuse and morbidity could not be proved because of the inability to control for aspects of care other than dialyzer reuse.     

核质置换技术治疗线粒体疾病的研究进展

线粒体疾病是线粒体基因组发生基因突变所导致的一类遗传疾病,目前尚无治愈方法。近年核质置换技术的出现为线粒体疾病的治疗提供了新思路。现有的核质置换技术包括生发泡移植、纺锤体移植、极体移植和原核移植技术,其中生发泡移植涉及的体外成熟可影响卵母细胞的发育潜能;纺锤体移植最大的挑战是纺锤体组装对机械刺激敏感,缺乏核膜包绕,操作过程可能对纺锤体造成损伤;极体移植违背了自然选择过程,其远期影响尚不明了;原核移植操作方便、基础研究证据充分,具有短期内向临床转化的潜能,但使用已经受精的合子作为胞质供体面临的伦理争议较大。本文就4种核质置换技术治疗线粒体疾病的应用现状进行综述。