Graham D T, Mark G E, Pomeroy A R, Macarthur E B
J Biomed Mater Res. 1984 Nov-Dec;18(9):1125-35. doi: 10.1002/jbm.820180914.
Biocompatibility tests have been compared for their suitability as routine safety tests for urinary catheters. Latex catheters from five manufacturers were tested by each of the following four methods: (1) a cell culture cytotoxicity assay of catheter extracts, (2) intracutaneous injection of the extracts into rabbits, (3) intramuscular implant of catheter pieces into rabbits, (4) catheterization of sheep (mucous membrane irritation). The rabbit intracutaneous and intramuscular tests are both current pharmacopoeial methods for ascertaining the suitability of polymers for medical use. The four tests each showed a cell or tissue response ranging from no detectable change to severe damage, according to the catheter batch or brand, and they each identified the same samples as most toxic and least toxic. However, they differed in sensitivity. The sheep test and the cell culture assay discriminated between catheters of intermediate toxicity and ranked as toxic catheters not identified as such by the two pharmacopoeial tests. The sheep test most closely approximates clinical usage, but is impractical for routine use. The cell culture assay is a suitable alternative. It also has the advantages of a clearly defined endpoint, good sensitivity, reproducibility, speed, and reduced animal usage.
已对生物相容性测试作为导尿管常规安全性测试的适用性进行了比较。对来自五个制造商的乳胶导尿管采用以下四种方法分别进行测试：(1) 导尿管提取物的细胞培养细胞毒性测定；(2) 将提取物皮内注射到兔子体内；(3) 将导尿管碎片肌肉植入兔子体内；(4) 对绵羊进行导尿（黏膜刺激）。兔子皮内和肌肉测试均为目前药典中用于确定聚合物是否适合医疗用途的方法。根据导尿管批次或品牌，这四种测试均显示出从无明显变化到严重损伤的细胞或组织反应，并且它们各自都确定了相同的毒性最大和最小的样本。然而，它们在敏感性方面存在差异。绵羊测试和细胞培养测定能够区分中等毒性的导尿管，并将两种药典测试未认定为有毒的导尿管列为有毒导尿管。绵羊测试最接近临床使用情况，但常规使用不切实际。细胞培养测定是一种合适的替代方法。它还具有终点明确、敏感性好、可重复性强、速度快以及减少动物使用量等优点。
