抗膀胱癌免疫毒素腔内灌注预防膀胱癌术后复发的临床观察

目的：探讨免疫毒素（IT）灌注预防膀胱癌术后复发的疗效及副作用。方法：本项研究采用免疫组化方法对膀胱癌标本进行免疫毒素结合活性研究,分析了结合活性与分级、分期的关系。并用免疫毒素灌注膀胱30例,预防膀胱癌复发,结合以前灌注免疫毒素、卡介苗、丝裂霉素－C的随访资料进行综合分析,结果：免疫毒素的结合活性,G1与G3间有显著性差异,随分级的增高而增强（P＜0．05）,G1与G2、G2与G3间无显著性差异,但随分级增高有增强趋势,结合活性与分期无明显关系（P＞0．05）。在膀胱灌注预防膀胱癌复发的3组中,1年内、2年内复发率相似无明显差异（P＞0．05）。IT组副作用明显低于BCG组和MMC组（P＜0．01）,而G组和MMC组间副作用无明显差异（P＞0．05）。结论：免疫毒素的结合活性G1与G3级肿瘤间有显著性差异,呈正相关,而与分期无关,这提示免疫毒素可能对恶性程度高的肿瘤预防效果好。免疫毒素的近期疗效与BCG和MMC相似,副作用明显小于后两者。

Prevention of postoperative recurrence of human bladder carcinoma by intravesical instillation of immunotoxin,a clinical study

OBJECTIVE: To observe the effects of intravesical instillation of immunotoxin (IT) on the prevention of recurrence of bladder carcinoma. METHODS: 128 patients with superficial bladder carcinoma or bladder carcinoma of T2 stage underwent operation, and then were randomly divided into 3 groups 2 - 3 weeks after operation to be instilled intravesically with solution of mitomycin (n = 53), Calmette-Guerin vaccine (n = 30), or IT (n = 45) once a week for 8 weeks and then once every month for 8 months respectively. Cystoscopy, blood routine examination, routine urine examination, and liver function test were conducted every 3 months. Immunohistochemistry was used to examine 30 samples of resected carcinoma. The effects and side effects were observed. Recurrence was verified by cystoscopy and/or ultrasonography, CT, and surgery. RESULTS: Out of the 30 samples of resected bladder carcinoma, 27 were staining positive (+ - + + +) with a positive rate of 90%. The binding activity was significantly different between the G(1) carcinoma of and the G(3) carcinoma (P < 0.05) and not significantly different between the G(1) and G(2) carcinomas and between the G(2) and G(3) carcinomas (both P > 0.05). The higher the grade of carcinoma, the stronger the binding activity of IT (P < 0.05). The recurrence rate in the first year were 11.1%, 10.0%, and 15.1% in the IT, BCG, and MMC groups respectively without significant difference between any 2 groups (all P > 0.05); and the recurrence rate in the 2nd year were 24.4%, 30.0%, and 28.3% in the 3 groups respectively without significant difference between any 2 groups (all P > 0.05). The side effect rate were 17.8% on the IT group, significantly lower than those in the other 2 groups (70.0% and 56.6% respectively, both P < 0.01). However, the side effect rates between the BCG group and MMC group was not significantly different (P > 0.05). CONCLUSION: IT is more effective on the prevention of recurrence of carcinomas with higher malignancy and has fewer side effects. The short-term effect of IT is similar to those of BCG and MMC. The activity of IT is associated with the grade and not the stage of carcinoma.