Opatrný Karel, Krouzzecký Ales, Polanská Kamila, Mares Jan, Tomsů Martina, Bowry Sudhir K, Vienken Jörg
Department of Medicine I, Charles University Medical School, Plzeò, Czech Republic.
Hemodial Int. 2006 Apr;10(2):201-8. doi: 10.1111/j.1542-4758.2006.00095.x.
The aim of the study was to assess the biocompatibility profile of a newly developed high-flux polysulfone dialyzer type (FX-class dialyzer). The new class of dialyzers incorporates a number of novel design features (including a new membrane) that have been developed specifically in order to enhance the removal of small- and middle-size molecules. The new FX dialyzer series was compared with the classical routinely used high-flux polysulfone F series of dialyzers. In an open prospective, randomized, crossover clinical study, concentrations of the C5a complement component, and leukocyte count in blood and various thrombogenicity parameters were evaluated before, and at 15 and 60 min of hemodialysis at both dialyzer inlet and outlet in 9 long-term hemodialysis patients using the FX60S dialyzers and, after crossover, the classical F60S, while in another 9 patients, the evaluation was made with the dialyzers used in reverse order. The comparison of dialyzers based on evaluation of the group including all procedures with the FX60S and the group including procedures with the F60S did not reveal significant differences in platelet count, activated partial thromboplastin times, plasma heparin levels, platelet factor-4, D-dimer, C5a, and leukocyte count at any point of the collecting period. Both dialyzer types showed a significant increase in the plasma levels of the thrombin-antithrombin III complexes; however, the measured levels were only slightly elevated compared with the upper end of the normal range. Biocompatibility parameters reflecting the behavior of platelets, fibrinolysis, complement activation, and leukopenia do not differ during dialysis with either the FX60S or the F60S despite their large differences in design and geometry features. Although coagulation activation, as evaluated by one of the parameters used, was slightly higher with the FX60S, it was still within the range seen with other highly biocompatible dialyzers and therefore is not indicative of any appreciable activation of the coagulation system. Thus, the incorporation of various performance-enhancing design features into the new FX class of dialyzers does not result in a deterioration of their biocompatibility profile, which is comparable to that of the classical F series of dialyzers.
本研究的目的是评估新开发的高通量聚砜透析器类型（FX 类透析器）的生物相容性概况。新型透析器采用了许多新颖的设计特点（包括一种新膜），这些特点是专门为增强中小分子的清除而开发的。将新型 FX 透析器系列与传统常规使用的高通量聚砜 F 系列透析器进行比较。在一项开放前瞻性、随机、交叉临床研究中，对 9 名长期血液透析患者使用 FX60S 透析器时，在透析器入口和出口处，于血液透析前、透析 15 分钟和 60 分钟时评估 C5a 补体成分浓度、血液中的白细胞计数以及各种血栓形成参数，交叉后使用传统的 F60S 透析器，而在另外 9 名患者中，以相反顺序使用透析器进行评估。基于对包括使用 FX60S 的所有程序的组和包括使用 F60S 的程序的组的评估对透析器进行比较，发现在采集期的任何时间点，血小板计数、活化部分凝血活酶时间、血浆肝素水平、血小板因子 4、D - 二聚体、C5a 和白细胞计数均无显著差异。两种透析器类型的血浆凝血酶 - 抗凝血酶 III 复合物水平均显著升高；然而，与正常范围上限相比，测量水平仅略有升高。反映血小板行为、纤维蛋白溶解、补体激活和白细胞减少的生物相容性参数在使用 FX60S 或 F60S 透析期间并无差异，尽管它们在设计和几何特征上有很大差异。尽管根据所使用的参数之一评估，FX60S 的凝血激活略高，但仍在其他高生物相容性透析器所见范围内，因此并不表明凝血系统有任何明显激活。因此，在新型 FX 类透析器中纳入各种性能增强设计特点并不会导致其生物相容性概况恶化，其与传统 F 系列透析器相当。
