人附睾蛋白4、CA125和卵巢恶性肿瘤风险模式在卵巢癌诊断中的应用

Clinical application of HE4,CA125 and risk of ovarian malignancy algorithm to ovarian cancer

目的:探讨人附睾蛋白4(HE4)、CA125和卵巢恶性肿瘤风险模式(ROMA)在卵巢癌诊断和临床分期中的应用价值。方法:采用化学发光微粒子免疫分析法检测56例卵巢癌患者和113例卵巢良性肿瘤患者的HE4、CA125水平并计算ROMA值。比较其在良恶性卵巢疾病中的水平变化、诊断价值及与临床分期之间的关系。结果:卵巢癌组HE4、CA125及ROMA均高于卵巢良性肿瘤组(P均<0. 05)。绝经前HE4、CA125及ROMA曲线下面积分别为0. 893、0. 883、0. 891,理想界值分别为69. 6 pmol/L、120. 0 U/mL、15. 9%,其灵敏度分别为79. 4%、76. 5%、79. 4%,特异度分别为100%、91. 4%、100%;绝经后HE4、CA125及ROMA曲线下面积分别为0. 899、0. 947、0. 947,理想界值分别为93. 2 pmol/L、57. 5 U/mL、40. 6%,其灵敏度分别为72. 7%、90. 9%、72. 7%,特异性分别为88. 4%、95. 3%、93. 0%。无论在绝经前后,HE4、CA125及ROMA在Ⅲ～Ⅳ期水平均比Ⅰ～Ⅱ期高,差异有统计学意义(P均<0. 05)。结论:HE4、CA125及ROMA在卵巢癌的诊断、临床分期中具有重要价值,尤其以ROMA临床价值为最大。

Objective:To assess the value of human epididymal protein 4(HE4)and CA125 level as well as risk of ovarian malignancy algorithm(ROMA)in the diagnosis and clinical staging of ovarian cancer.Methods:Fifty-six cases of ovarian cancer and 113 cases of benign ovarian neoplasm were included,and HE4 and CA125 levels were measured using chemiluminescent microparticle immunoassay.ROMA was calculated by HE4 and CA125 levels combined with menopause status.Then the changes of HE4 and CA125 levels were compared between cases of malignancies and benign lesions to estimate the diagnostic value and association with clinical staging.Results:HE4,CA125 and ROMA were higher in the ovarian cancer group than in the benign ovarian tumor group(P<0.05).The area of ROC of HE4,CA125 and ROMA was 0.893,0.883 and 0.891,respectively in premenopausal stage.The ideal cut-off value was 69.6 pmol/L,120 U/mL and 15.9%.The sensitivity was 79.4%,76.5%and 79.4%,and the specificity 100%,91.4%and 100%,respectively.The area of ROC of HE4,CA125 and ROMA in postmenopausal stage was 0.899,0.947 and 0.947,and the ideal cut-off value was 93.2 pmol/L,40.6%and 57.5 U/mL.The sensitivity was 72.7%,90.9%and 72.7%,and the specificity 88.4%,95.3%and 93%,respectively.The average level of HE4,CA125 and ROMA was higher in stageⅢ-Ⅳthan in stageⅠ-Ⅱeither before or after menopause.The difference was significant(P<0.05).Conclusion:HE4,CA125 and ROMA have important value in the diagnosis and clinical staging of ovarian cancer,especially with the greatest clinical value of ROMA.