Frinak S, Polaschegg H D, Levin N W, Pohlod D J, Dumler F, Saravolatz L D
Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, MI.
Int J Artif Organs. 1991 Nov;14(11):691-7.
Increased concerns about pyrogenic contamination of dialysate have led to the development of an on-line dialysate filtration system. Bacteriological testing of the system was performed (n = 6) by introducing bicarbonate concentrate contaminated with E. coli 026:B 6 (3 x 10(9) cfu/ml) into a dialysis machine equipped with a two-stage polysulfone filtration system. The bacterial concentration of the dialysate entering the filtration system was maintained above 10(6) cfu/ml and endotoxin levels ranged from 30-300 ng/ml during the 3-hour test period. Bacterial and endotoxin levels on the input side of the first-stage filter reached minimum concentrations of 5.4 x 10(9) cfu/ml and 30,000 ng/ml respectively. All output samples of filtered dialysate showed no bacterial growth and endotoxin levels were below the sensitivity (0.003 ng/ml) of the LAL assay. A dialysis machine (QD = 500), equipped with a single stage filtration system, was used for 18 months of clinical testing. In order to evaluate the system's reliability with regard to membrane failures and reduced dialysate flow, filter membrane integrity was verified weekly using a pressure holding test and dialysate flow was measured under routine clinical conditions. No membrane failures occurred, and dialysate flow was maintained at 511 +/- 17 ml/min (n = 70) during the test period.
dialysate filtration is an effective and practical method for prevention of pyrogenic reactions due to high levels of bacteria and endotoxins.
对透析液热原污染的日益关注促使了在线透析液过滤系统的研发。通过将被大肠杆菌O26:B6（3×10⁹ cfu/ml）污染的碳酸氢盐浓缩液引入配备两级聚砜过滤系统的透析机中，对该系统进行了细菌学测试（n = 6）。在3小时的测试期间，进入过滤系统的透析液细菌浓度保持在10⁶ cfu/ml以上，内毒素水平在30 - 300 ng/ml之间。一级过滤器输入侧的细菌和内毒素水平分别达到最低浓度5.4×10⁹ cfu/ml和30,000 ng/ml。所有过滤后透析液的输出样本均未显示细菌生长，内毒素水平低于鲎试剂检测法的灵敏度（0.003 ng/ml）。一台配备单级过滤系统的透析机（QD = 500）用于18个月的临床测试。为了评估该系统在膜故障和透析液流量降低方面的可靠性，每周使用压力保持测试验证滤膜完整性，并在常规临床条件下测量透析液流量。未发生膜故障，测试期间透析液流量维持在511±17 ml/min（n = 70）。
透析液过滤是预防因细菌和内毒素水平过高导致热原反应的有效且实用的方法。
