摘要:目的 研究血清人附睾蛋白4（HE4）在卵巢恶性肿瘤中的诊断价值。方法 用酶联疫吸附试验方法对卵巢上皮性癌组（54例）、盆腔良性疾病组（60例）、正常组（60例）妇女血清中HE4和CA125进行双盲检测，结果以中位数表示，分析比较两者单独检测诊断卵巢恶性肿瘤的价值。血清HE4和CA125的正常值分别为0~140pmol/L和0~35KU/L，其中任一指标高于正常即为阳性。结果 ①卵巢上皮性癌组血清HE4和CA125水平分别为142.72pmol/L和136.07KU/L，分别与盆腔良性疾病组（分别为63.72pmol/L和72.20KU/L）和正常组（分别为57.82pmol/L和57.42KU/L）比较，差异均有统计学意义（P<0.01）。②以盆腔良性疾病组作参照人群时，HE4和CA125单独检测的受试者工作特征曲线下面积（ROC-AUC）分别为0.958和0.886，两者比较，差异有统计学意义（P<0.001）。③以ROC曲线最左上方的点130pmol/L、正常组95%参考值80pmol/L和正常值的上限140pmol/L为界值点，比较HE4单项检测对卵巢上皮性恶性肿瘤的诊断能力，结果显示，界值点为80pmol/L的特异度和阳性预测值均为88%，明显低于界值点为130（分别为93%和90%）和140pmol/L（分别为93%和95%）时的特异度和阳性预测值（P<0.01）。结论 HE4单项检测诊断卵巢上皮性恶性肿瘤的特异度优于CA125单项检测。以140pmol/L为界值点，对卵巢上皮性恶性肿瘤的早期诊断准确率更高，而以130pmol/L为界值点有利于卵巢上皮性恶性肿瘤的筛查、降低漏诊率。

Abstract：Objective To evaluate the value of human epididymis secretory protein 4 (HE4) in the diagnosis of epithelial ovarian malignancy. Methods The serum HE4 and CA125 levels in 54 patients with epithelial ovarian cancer, 60 cases of benign ovarian diseases and 60 healthy women were detected. The serum levels and the diagnosis efficiency of the HE4 and CA125 were analyzed. Results The median levels of HE4 and CA125 were significantly higher in epithelial ovarian cancer group (142.72 pmol/L and 136.07ku/L respectively) than those of the benign ovarian diseases group (63.72pmol/L and 70.20ku/L respectively) and healthy women group (57.82pmol/L and 57.42ku/L respectively)(P<0.01). The operating characteristic-area under the curve (ROC-AUC) of HE4 and CA125 assay were 0.958 and 0.886 respectively, there was statistically difference between them (P<0.001). Conclusion The specificity of HE4 assay has advantage over CA 125 in the diagnosis of epithelial ovarian malignancy.