Fatela-Cantillo Daniel, Fernández-Suárez Antonio, Menéndez Violeta, Galán Juan Antonio, Filella Xavier
Department of Clinical Analysis, Hospitales Universitarios Virgen del Rocío, Sevilla, Spain.
J Clin Lab Anal. 2005;19(4):167-71. doi: 10.1002/jcla.20072.
We evaluated serum levels of soluble fragments of cytokeratin 19 (CYFRA 21-1) by immunoassay (ES-700; Roche Diagnostics, Mannheim, Germany) to assess its usefulness in the diagnosis and follow-up of bladder cancer. The study included 39 patients with a diagnosis of transitional cell carcinoma (group 1) and 190 patients (group 2) with no evidence of tumor. In group 2, 180 patients had a history of bladder cancer, and 10 had benign prostatic hyperplasia. Significant differences in CYFRA 21-1 concentrations between groups 1 and 2 (P<0.01) were noted. However, CYFRA 21-1 levels did not significantly differ between the patients with benign prostatic hyperplasia and those with bladder cancer (P=0.274). CYFRA 21-1 values were higher in invasive bladder cancer compared to that detected in superficial stages (P=0.011). Setting the optimal cutoff value at 2.5 ng/mL resulted in a sensitivity of 43.6% and a specificity of 82.1%. No statistical differences were found when we compared disease-free time among the 66 patients with recurrences (30.7 months with levels <2.5 ng/mL vs. 41.2 months with levels >2.5 ng/mL; P=0.248). The risk of recurrence in patients with levels lower than 2.5 ng/mL (0.79) was no different (P=0.097) from that found in patients with higher levels (1.69). CYFRA 21-1 serum levels do not provide enough sensitivity to justify its application in routine protocols for the detection and follow-up of bladder cancer.
我们通过免疫测定法（ES - 700；德国曼海姆罗氏诊断公司）评估了细胞角蛋白19可溶性片段（CYFRA 21 - 1）的血清水平，以评估其在膀胱癌诊断和随访中的作用。该研究纳入了39例诊断为移行细胞癌的患者（第1组）和190例无肿瘤证据的患者（第2组）。在第2组中，180例患者有膀胱癌病史，10例有良性前列腺增生。第1组和第2组之间CYFRA 21 - 1浓度存在显著差异（P<0.01）。然而，良性前列腺增生患者和膀胱癌患者之间的CYFRA 21 - 1水平无显著差异（P = 0.274）。与浅表期膀胱癌相比，浸润性膀胱癌的CYFRA 21 - 1值更高（P = 0.011）。将最佳临界值设定为2.5 ng/mL时，敏感性为43.6%，特异性为82.1%。在比较66例复发患者的无病时间时未发现统计学差异（水平<2.5 ng/mL的患者为30.7个月，水平>2.5 ng/mL的患者为41.2个月；P = 0.248）。水平低于2.5 ng/mL的患者复发风险（0.79）与水平较高患者（1.69）的复发风险无差异（P = 0.097）。CYFRA 21 - 1血清水平的敏感性不足以证明其在膀胱癌检测和随访常规方案中的应用价值。
