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

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

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LewisX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：受试时象为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LewisX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：LewisX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。

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 speci fiery 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.