血清人附睾分泌蛋白4检测在卵巢癌诊断中的临床应用

Clinical Value of Serum Human Epididymial Protein 4 in The Diagnosis of Ovarian Cancer

[目的]探讨人附睾分泌蛋白4（human epididymial protein 4,HE4）在卵巢癌诊断中的价值。[方法]采用酶联免疫吸附试验和化学发光法检测48例卵巢癌患者、33例卵巢良性肿瘤患者以及38例健康体检者血清HE4以及糖类抗原125（CA125）的水平。[结果]血清HE4诊断卵巢癌的ROC曲线下面积为0.921（95%CI：0.887~0.955）。HE4 86.5pmol/L为阈值时诊断敏感度为66.7%,特异性为84.5%。而血清CA125诊断卵巢癌的ROC曲线下面积为0.902（95%CI：0.857~0.947）。CA125 48.2U/ml为阈值时诊断敏感度为62.5%,特异性为81.7%。HE4与CA125联合检测诊断卵巢癌的ROC曲线下面积为0.947（95%CI：0.914~0.980）。卵巢癌Ⅲ~Ⅳ期患者血清HE4水平明显高于Ⅰ~Ⅱ期患者（P〈0.001）,有淋巴结转移患者血清HE4水平明显高于无淋巴结转移患者（P〈0.001）。[结论]HE4可作为卵巢癌诊断的血清学标志物,且与CA125联合检测可提高卵巢癌诊断效率。

[Purpose] To evaluate the diagnostic value of human epididymal protein 4（HE4） for ovarian cancer.[Methods] Forty-eight cases with ovarian cancer,33 cases with benign ovarian tumor and 38 cases of healthy control were enrolled.Serum HE4 and carbohydrate antigen 125（CA125） level were detected by enzyme-linked immunosorbent assay and chemiluminescence assay.[Results] The area of ROC curve of HE4 for ovarian cancer diagnosis was 0.921（95%CI： 0.887 ~0.955）.The sensitivity was 66.7% and specificity was 84.5% while HE4 cut-off was 86.5pmol/L.The area of ROC curve of CA125 for ovarian cancer diagnosis was 0.902（95%CI： 0.857 ~0.947）.The sensitivity was 62.57% and specificity was 81.7% while CA125 cut-off was 48.2 U/ml.The area of ROC curve of HE4 combined with CA125 for ovarian cancer diagnosis was 0.947（95%CI：0.914~0.980）.Serum HE4 level in patients with stage Ⅲ~ Ⅳ or with lymph node metastasis was significantly higher than in stage Ⅰ~Ⅱ or without lymph node metastasis respectively（P0.05）.[Conclusion] HE4 might be used as a serum marker in the diagnosis of ovarian cancer.It can improve the efficiency of diagnosis of ovarian cancer when combined with CA125.