Johnson H J, Northup S J, Seagraves P A, Atallah M, Garvin P J, Lin L, Darby T D
J Biomed Mater Res. 1985 May-Jun;19(5):489-508. doi: 10.1002/jbm.820190503.
Methods of assessing the biocompatibility of materials for use in medical devices were evaluated. Ten materials were tested using quantitative, objectively graded in vitro biochemical and functional assays employing four cell lines (CCL 1, 74, 76, and 131) used in previous work and five primary cell types (human lymphocytes, polymorphonuclear leukocytes, and mixed leukocytes, mouse macrophages, and mouse embryo). The biochemical methods (DNA synthesis, protein synthesis, and ATP activity) demonstrated good agreement in toxicity ranking of the materials, regardless of which cell culture was used and, also, the cell cultures responded similarly for each method. Methods that measured functional characteristics of cells (adhesion and phagocytosis) were highly sensitive but had low toxicity ranking agreement and reproducibility. Assays (defined as method and cell culture combinations) using cell lines were more reproducible than assays using primary cell types. Significant differences in sensitivity were noted among the assay systems for particular material types. The in vitro assays were more sensitive to differences in material composition than was a 90-day assay by subcutaneous implantation in rats.
对用于医疗设备的材料的生物相容性评估方法进行了评价。使用先前工作中使用的四种细胞系（CCL 1、74、76和131）以及五种原代细胞类型（人淋巴细胞、多形核白细胞和混合白细胞、小鼠巨噬细胞和小鼠胚胎），通过定量、客观分级的体外生化和功能测定法对十种材料进行了测试。生化方法（DNA合成、蛋白质合成和ATP活性）在材料毒性排名方面显示出良好的一致性，无论使用哪种细胞培养，并且每种方法的细胞培养反应也相似。测量细胞功能特性（粘附和吞噬作用）的方法高度敏感，但毒性排名一致性和再现性较低。使用细胞系的测定（定义为方法和细胞培养组合）比使用原代细胞类型的测定更具再现性。对于特定材料类型，测定系统之间在敏感性上存在显著差异。体外测定对材料成分差异的敏感性高于大鼠皮下植入90天的测定。
