血型抗原Lewis X免疫组化染色法与尿液脱落细胞学对膀胱移行细胞癌的诊断比较

目的:采用多中心临床试验方案,以病理诊断为金标准,比较尿液Lewis X抗原免疫组化染色法与尿液脱落细胞学(voided urine cytology,VUC)对膀胱移行细胞癌(TCC)的诊断价值。方法:受试对象为258例因怀疑膀胱癌收住入院的患者以及97例膀胱癌保留膀胱手术后随访患者。尿液脱落细胞标本分别行常规细胞学检查和免疫组化Envision二步法Lewis X抗原染色,计数每100个脱落细胞所含阳性染色细胞数目。结果:根据ROC曲线得出最佳阈值为5个阳性细胞/100脱落细胞,此时灵敏度单次试验为82.1%~84.2%,特异性为80.3%~78.9%,2次测定作为平行试验灵敏度为86.8%,特异性为77.0%;灵敏度提高,特异性略有下降。以11个阳性细胞/100脱落细胞为阈值的灵敏度和特异性分别为66.0%和95.4%。VUC的灵敏度和特异性分别为47.6%和94.7%。结论:Lewis X抗原灵敏度高于VUC,对低分级、早期肿瘤差别尤其明显。与B型超声结合可以提高灵敏度。

Comparison of the urine-based tumor marker Lewis X and voided urine cytology in the diagnosis of transitional cell carcinoma in the bladder

OBJECTIVE: To evaluate the clinical usefulness of the urine-based tumor marker Lewis X and voided urine cytology (VUC) in the diagnosis of transitional cell carcinoma (TCC) in the bladder.METHODS: 258 patients who were evaluated because of painless hematuria or irritative symptoms and 97 patients who were examined during the follow-up period visits after the resection of TCCs. Voided urine samples were obtained from each patient for immunocytology and cytology. Positive cells per 100 cells were counted. RESULTS: Five pecent of stained cells in each slide was the best cut-off according to ROC curve. The sensitivity and specificity of exam on a single sample/each patient were 82.1%-84.2% and 80.3%-78.9%, respectively. The combination of immunocytology on two consecutive samples each patient had a higher sensitivity and a lower specificity, which were 86.8% and 77.0%. When a higher cut-off of 11% stained cells in each slide was taken, the similar specificity between immunocytology and cytology (95.4% versus 94.7%, respectively) and higher sensitivity (66.0% versus 47.6%, respectively) were achieved. CONCLUSIONS: The sensitivity of immunohistochemical stain on urine exfoliated cell using Lewis X antigen is higher than voided urine cytology in detecting TCC, especially in low grade and early stage tumors. The combination of Lewis X test and B-ultrasound can increase the detecting rate.