Talja M, Andersson L C, Ruutu M, Alfthan O
Br J Urol. 1985 Oct;57(5):579-84. doi: 10.1111/j.1464-410x.1985.tb05870.x.
The tissue toxicity of 23 urinary catheter batches (6 latex and 2 non-latex brands) was tested in vitro and in vivo. In vitro, a human T-cell leukemia line (JM) was cultured in the presence of different concentrations of eluates made from the catheters. The cytotoxicity of the eluates was assessed from their ability to inhibit DNA synthesis measured by incorporation of 3H-thymidine. In vivo, two methods were used. Strips of catheters were implanted into the rabbit dorsal muscle and pieces of catheters were implanted into the rat peritoneal cavity. After four days, the foreign body reaction, type of inflammation and necrosis were quantified macroscopically and by light microscopy. The results of the in vitro cytotoxicity test were correlated with those of in vivo methods. The rat peritoneal implantation test correlated better with the cell culture test (P less than 0.01) than with the rabbit muscle implantation test (P less than 0.05). Based on the clinical experience of urethral stricture complications caused by urinary catheters, catheters yielding eluate which at 30% dilution inhibited 50% DNA synthesis were regarded as toxic. According to this, the rabbit muscle implantation test was not reliable in testing the tissue toxicity of urinary catheters, while the cell culture test was quantitative and seemed to correlate with both the rat peritoneal implantation test and with the clinical complications observed.
对23个批次的导尿管（6个乳胶品牌和2个非乳胶品牌）进行了体外和体内组织毒性测试。在体外，将人T细胞白血病细胞系（JM）在由导尿管制成的不同浓度洗脱液存在的情况下进行培养。通过3H-胸腺嘧啶核苷掺入法测量洗脱液抑制DNA合成的能力，以此评估其细胞毒性。在体内，使用了两种方法。将导尿管条植入兔背部肌肉，并将导尿管碎片植入大鼠腹腔。四天后，通过肉眼和光学显微镜对异物反应、炎症类型和坏死情况进行定量分析。体外细胞毒性测试结果与体内测试结果相关。大鼠腹腔植入试验与细胞培养试验的相关性优于兔肌肉植入试验（P<0.01 vs P<0.05）。根据导尿管引起尿道狭窄并发症的临床经验，在30%稀释度下能抑制50%DNA合成的洗脱液所对应的导尿管被视为有毒。据此，兔肌肉植入试验在测试导尿管组织毒性方面不可靠，而细胞培养试验具有定量性，似乎与大鼠腹腔植入试验以及观察到的临床并发症均相关。
