INVIVO VALIDATION OF A CELL-CULTURE TEST FOR BIOCOMPATIBILITY TESTING OF URINARY CATHETERS
INVIVO VALIDATION OF A CELL-CULTURE TEST FOR BIOCOMPATIBILITY TESTING OF URINARY CATHETERS
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DOI：
10.1002/jbm.820180914
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发表时间：
1984-01-01
期刊：
影响因子：
--
通讯作者：
MACARTHUR, EB
中科院分区：
文献类型：
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作者：
GRAHAM, DT;MARK, GE;MACARTHUR, EB
已经比较了生物相容性试验作为导尿管常规安全性试验的适用性。通过以下4种方法对来自5家制造商的乳胶导管进行了试验：导管浸提液的细胞培养细胞毒性试验、家兔皮内注射浸提液、i.m.将导管碎片植入家兔体内和羊的导管插入术（粘膜刺激）。家兔皮内和i.m.试验都是用于确定聚合物对医疗用途的适用性的现行药典方法。根据导管批次或品牌，4项测试均显示细胞或组织反应，范围从不可检测的变化到严重损伤，并且它们均将相同的样品确定为毒性最大和毒性最小。但是，它们的敏感性不同。绵羊试验和细胞培养试验区分了中等毒性导管和2项药典试验未确定的毒性导管。绵羊试验最接近临床使用，但不适用于常规使用。细胞培养试验是一种合适的替代方法。它还具有明确定义的终点，良好的灵敏度，重现性，速度和减少动物使用的优点。
Biocompatibility tests have been compared for their suitability as routine safety tests for urinary catheters. Latex catheters from 5 manufacturers were tested by each of the following 4 methods: a cell culture cytotoxicity assay of catheter extracts, intracutaneous injection of the extracts into rabbits, i.m. implant of catheter pieces into rabbits and catheterization of sheep (mucous membrane irritation). The rabbit intracutaneous and i.m. tests are both current pharmacopoeial methods for ascertaining the suitability of polymers for medical use. The 4 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 2 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.