目的：探讨术前血清人附睾蛋白4（HE4）、CA125对Ⅰ期高危子宫内膜癌（EC）患者的预测价值并确立最佳诊断临界值。方法收集231例Ⅰ期EC患者的临床病理资料，检测术前血清HE4、CA125水平，分析两者与临床病理特征的关系。根据相关依据将231例EC患者分为高危组96例，低危组135例，绘制受试者工作特征曲线（ROC），计算曲线下面积（AUC），以约登指数最大时确立HE4、CA125诊断Ⅰ期高危EC的最佳临界值。结果肌层浸润深度、脉管浸润情况、子宫下段受累情况、病灶直径及危险分组不同的Ⅰ期EC患者HE4和CA125水平差异均有统计学意义（均P<0.05），绝经状态、合并高血压情况、病理类型、组织学分级及宫颈内膜腺体受累情况不同的Ⅰ期EC患者仅HE4水平差异有统计学意义（均P<0.05），术前血清HE4与CA125水平呈正相关（r=0.262，P<0.05）。HE4诊断Ⅰ期高危EC患者的AUC为0.794（95%CI：0.734~0.854），临界值为74 pmol/L，敏感度、特异度、阳性预测值、阴性预测值、准确率为75.0%、83.0%、75.8%、82.4%、79.7%；CA125相应值为0.696（95%CI：0.624~0.767）、17 kU/L、56.3%、85.9%、74.0%、73.4%、73.6%；两者联合诊断的AUC为0.847（95%CI：0.796~0.899），相应预测值为95.8%、77.0%、74.8%、96.3%、84.8%。结论 HE4、CA125诊断Ⅰ期高危EC的最佳临界值分别为74 pmol/L、17 kU/L，联合检测预测Ⅰ期高危EC的敏感度、阴性预测值及准确率优于单项检测。%Objective To investigate the predictive value of preoperative serum human epididymis protein 4 (HE4) and CA125 in patients with high risk of stage Ⅰ endometrial cancer (EC)and to identify the optimal cutoff values. Methods Clinical and pathological data of 231 patients with stage Ⅰ EC were included in this study. Patients were divided into high risk group (n=96) and low risk group (n=135). The preoperative serum levels of HE4 and CA125 were measured, and their correlations with clinical pathological features were analyzed. The ROC curves were generated to determine optimal cutoff values of HE4 and CA125 levels with the maximum Youden index for prediction of high risk EC. Results There were significant differences in serum levels of HE4 and CA125 between patients with different depths of myometrial invasion, with or without vascular invasion, with or without lower uterine segment involvement, with different diameters of tumor and different risk classifications of stage ⅠEC (P<0.05). There were significant differences in serum levels of HE4 between patients with different menopausal status, hypertension, pathological types, histological grading and the involvement of cervical endometrial glands (P<0.05). The preoperative serum levels of HE4 and CA125 were positive correlated (r=0.262, P<0.05). The AUC value of HE4 for diagnosing stageⅠEC was 0.794(95%CI:0.734-0.854),the cutoff value was 74 pmol/L, the sensitivity was 75.0%, specificity was 83.0%, positive predictive value was 75.8%, negative predictive value was 82.4% and the accuracy rate was 79.7%. The AUC value of CA125 for diagnosing stage Ⅰ EC was 0.696 (95%CI: 0.624-0.767), the cutoff value was 17 kU/L, the sensitivity was 56.3%, specificity was 85.9%, positive predictive value was 74.0%, negative predictive value was 73.4%and the accuracy rate was 73.6%, respectively. The AUC value of combination of both markers was 0.847 (95%CI: 0.796-0.899), the corresponding values were 95.8%, 77.0%, 74.8%, 96.3%and 84.8%, respectively. Conclusion The best cutoff values of HE4 and CA125 are 74 pmol/L and 17 kU/L for detecting high risk stageⅠEC. The combined detection is better than that of the single detection in sensitivity, negative predictive value and accuracy rate.
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