Korhonen P, Talja M, Ruutu M, Andersson L C, Alfthan O
Kymenlaakso Central Hospital, Kotka, Finland.
Urol Res. 1991;19(2):127-30. doi: 10.1007/BF00368190.
International biocompatibility standards for urinary catheters have not yet been set. The used in vivo animal tests earlier have been shown to be insensitive and expensive. The present study compared the sensitivity and other properties of two in vitro cell culture methods, the reference method of the British Standards Institution (BSI) and the thymidine incorporation method (DNA synthesis inhibition test. The cell culture toxicities of thirty-seven latex catheters were measured and 84.8% of the catheters tested passed the BSI reference test while 94.6% passed the thymidine incorporation test. The overall batch-to-batch correlation was poor (p greater than 0.05), but within brands the correlation was better. This is obviously to be explained by the differences the characteristics of the tests and/or the chemical composition of the catheters. The thymidine incorporation test is easier to perform, requires less manpower, and is therefore less liable to subjective interpretations than the BSI test. The biocompatibility toxicity limits for latex urinary catheters need to be tightened. Our experience in this study indicates that the thymidine incorporation test or tests similar to it, which can be highly automated can be recommended for biocompatibility screening in large series, and BSI reference test can be used additionally in unclear cases.
目前尚未制定导尿管的国际生物相容性标准。早期使用的体内动物试验已被证明不够灵敏且成本高昂。本研究比较了两种体外细胞培养方法的灵敏度及其他特性，即英国标准协会（BSI）的参考方法和胸腺嘧啶核苷掺入法（DNA合成抑制试验）。对37根乳胶导尿管的细胞培养毒性进行了测定，84.8%的受试导尿管通过了BSI参考试验，而94.6%通过了胸腺嘧啶核苷掺入试验。总体批次间相关性较差（p大于0.05），但同一品牌内相关性较好。这显然可以通过试验特性和/或导尿管化学成分的差异来解释。胸腺嘧啶核苷掺入试验操作更简便，所需人力更少，因此与BSI试验相比，主观解释的可能性更小。乳胶导尿管的生物相容性毒性限值需要收紧。我们在本研究中的经验表明，对于大批量的生物相容性筛查，可推荐使用高度自动化的胸腺嘧啶核苷掺入试验或类似试验，在情况不明时可额外使用BSI参考试验。
