Ikonomov V, Haase G, Stefanidis I, Melzer H, Mann H
Medizinische Klinik II, Aachen, Germany.
Int J Artif Organs. 2002 May;25(5):379-85. doi: 10.1177/039139880202500506.
Bacterial contamination of dialysis fluid has long been recognized as a problem in hemodialyis. Cytokines released as a consequence of contaminated dialysis fluid are believed to be responsible for many acute and chronic side effects in patients undergoing renal replacement therapy. For several years now, attempts have been made to eliminate pyrogenic substances and ensure a sterile and endotoxin-free dialysis fluid. A recent dialysis fluid filter known as DIASAFE, containing a membrane based on Polysulfone (Fresenius), was tested for a period of 1,000 hours (approx. 14 weeks). Dialysis fluid samples were collected once weekly before and behind the filter and cultivated for detection of microorganisms and endotoxins. Additionally, starting after the fourth week of the study, serum samples were collected weekly and the beta2-microglobulin concentration was determined. The filter reduced microorganisms at a rate of at least 10(5) and in the majority of cases (86% of samples) by more than 106. Under clinical conditions the stability and microbiological functionality of the filters could be demonstrated for more than 1,000 hours and 150 disinfecting cycles. In four cases of endotoxin burden (> 0.5 IU/ml) in the dialysis fluid in front of the filter the concentration behind the filter was lower than 0.1 IU/ml, indicating effective reduction of endotoxins. A tendency to a reduction of beta2-microglobulin in serum from 32.5+/-3.9 mg/L to 21.5+/-5.3 mg/L was observed. These results indicate that the dialysis fluid filter used was effective, dramatically reducing the bacterial contaminants in dialysis fluid, thus protecting patients from the potentially harmful acute and long-term life-threatening consequences of contaminated dialysis fluid.
透析液的细菌污染长期以来一直被认为是血液透析中的一个问题。因受污染的透析液而释放的细胞因子被认为是导致接受肾脏替代治疗的患者出现许多急慢性副作用的原因。多年来，人们一直试图消除致热物质，并确保透析液无菌且无内毒素。最近，一种名为DIASAFE的透析液过滤器，其含有一种基于聚砜（费森尤斯公司）的膜，经过了为期1000小时（约14周）的测试。每周在过滤器前后采集一次透析液样本，并进行培养以检测微生物和内毒素。此外，从研究的第四周开始，每周采集血清样本并测定β2-微球蛋白浓度。该过滤器能以至少10⁵的速率减少微生物，在大多数情况下（86%的样本）减少超过10⁶。在临床条件下，该过滤器的稳定性和微生物学功能在超过1000小时和150次消毒循环中都得到了验证。在过滤器前的透析液出现4例内毒素负荷（>0.5 IU/ml）的情况下，过滤器后的浓度低于0.1 IU/ml，表明内毒素得到了有效减少。观察到血清中β2-微球蛋白有从32.5±3.9 mg/L降至21.5±5.3 mg/L的趋势。这些结果表明所使用的透析液过滤器是有效的，能显著减少透析液中的细菌污染物，从而保护患者免受受污染透析液潜在的有害急性和长期危及生命的后果。
