Abstract: ObjectiveTo evaluate the diagnostic value of human epididymis protein 4(HE4) and carbohydrate antigen 125(CA125) for distinguishing between benign and malignant ovarian neoplasms. Methods1109 patients with ovarian neoplasms were enrolled in this study, serum concentration of HE4 and CA125 was assayed using ELISA technique.And the markers were evaluated for significance separately and in combination. Results1 Serum levels of HE4 and CA125 were significantly higher in postmenopausal women than those in premenopausal women（t=8.40，P＜0.05；t=7.02，P＜0.05）. In addition, the more children the patients born, the higher serum levels of these two markers were（F=15.36，P＜0.05；F=13.00，P＜0.05）. 2 Serum HE4 levels were significantly higher in the ovarian cancer patients compared with those seen in patients with benign or borderline tumor（t=13.68，P＜0.05；t=14.94，P＜0.05）. Serum CA125 levels were significantly higher in the ovarian cancer patients compared with those seen in patients with benign or borderline tumor（t=14.16，P＜0.05；t=17.27，P＜0.05）. Morever, it also appared in the ovarian cancer patients with ascites and vascular embolism. Morever,the levels of HE4 were significantly higher in the ovarian cancer with ascites and vascular embolism than without it（t=7.08，P＜0.05；t=4.41，P＜0.05）,the levels of CA125 were significantly higher in the ovarian cancer with ascites and vascular embolism than without it（t=9.67，P＜0.05；t=4.75，P＜0.05）. 3 During followup, serum HE4 and CA125 levels significantly decreased at 3 months after operation（t=9.86，P＜0.05；t=5.12，P＜0.05）. 4 Receiver operating characteristic curve，ROC) analysis revealed that no difference was observed in AUC values for HE4, CA125 and risk of ovarian malignancy algorithm(ROMA）. 5 Compared to CA125, HE4 had significantly higher specificity and lower sensitivity.However,sensitivity were increased when the two markers were combined with each other. However,the sensitivity of combination with two markers was higher than single detection and ROMA,but the specificity was lower in combination with two markers than single detection and ROMA.If we divide the ROMA by a woman′s menopausal status, ROMA has a higher sensitivity（73.84%，84.19%） and lower specificity（66.06%，66.67%）. ConclusionsThe levels of CA125 has a high sensitivity, and the levels of HE4 is a high specificity. CA125 combined with HE4 can provide a more sensitivity and accurate predictor of ovarian cancer than either alone.

Key words: Ovarian neoplasms, Antigens, tumorassociated,carbohydrate, Human epididymis protein4