Kolb G, Müller T, Höffken H, Joseph K, Lange H, Havemann K
Department of Internal Medicine, Philipps University of Marburg, Germany.
Biomater Artif Cells Immobilization Biotechnol. 1992;20(5):1233-48. doi: 10.3109/10731199209117349.
All statements referring to biocompatibility of dialyzers depend on the suggestion of a constant and reproducible structure of the investigated membrane material. The data presented here strike this concepts in case of hemophane. Two commercially available hemophane dialyzers, the GF MC 120 (Gambro) and the MO 450 (SMAD) membranes, were compared. Significant differences could be seen in the induction of leukopenia and leukocyte sequestration reaction within patients lungs, but also in capacity to influence granulocyte oxidative metabolism and release of granular enzymes. According to these data it seems questionable whether hemophane is a membrane material with constant structure and quality normally expected for products bearing trade names. Excluding other differences (like surface-area or sterilization method) variable amounts of DEAE substituents and/or an inconstant distribution of the DEAE groups within the membranes may be the most possible reason responsible for the differences found. The study underlines the urgent need of an exact physico-chemical characterization of dialyzer membranes and is therefore a challenge for free publication of such basic data by the producers.
所有关于透析器生物相容性的陈述都依赖于所研究膜材料具有恒定且可重复结构这一假设。本文所呈现的数据在血仿膜的情况下对这一概念提出了挑战。对两种市售的血仿膜透析器，即GF MC 120（金宝公司）和MO 450（SMAD）膜进行了比较。在诱导白细胞减少和患者肺部白细胞隔离反应方面可以看到显著差异，而且在影响粒细胞氧化代谢和颗粒酶释放的能力方面也存在显著差异。根据这些数据，血仿膜是否是一种具有恒定结构和质量（这是通常对有商品名产品所期望的）的膜材料值得怀疑。排除其他差异（如表面积或灭菌方法），二乙氨基乙基（DEAE）取代基数量的变化和/或膜内DEAE基团分布的不稳定可能是造成所发现差异的最可能原因。该研究强调了对透析器膜进行精确物理化学表征的迫切需求，因此对生产商免费公开此类基础数据构成了挑战。
