Abstract: Objective　To investigate the clinical value of human epididymis protein 4（HE4）on diagnosing gynecological pelvic lesions. Methods　The HE4 and carbohydrate antigen 125(CA125) levels in sera from 133 patients with gynecological pelvic lesions （ovarian cancer: 7 cases，intrauterine tumor: 40 cases， benign ovarian disease: 34 cases and benign uterus disease: 52 cases）and 43 healthy women （as the control group）were determined by enzymelinked immunosorbent assay (ELISA) and chemiluminescence immunoassay, respectively.The patients were classified according to the postoperative pathology results. The control group′s 〖AKx-D〗±2s was as the normal reference range, and the HE4 and CA125 levels were used to evaluate the sensitivity and specificity on diagnosing gynecological pelvic malignant lesions. Results　The threshold values of serum HE4 and CA125 in the control group were 55.86 pmoL/L and 35 kU/L respectively.The levels of serum HE4 and CA125 had no statistical significance in the patients with benign ovarian disease, benign uterus disease and the control group（P>0.05）, and the levels of serum HE4 and CA125 in patients with ovarian cancer were significantly higher than the normal reference range and those in patients with intrauterine tumor, benign ovarian disease, benign uterus disease and the control group(P<0.01). The levels of serum HE4 in patients with intrauterine tumor were significantly higher than the normal reference range and those in patients with benign ovarian disease, benign uterus disease and the control group(P<0.05). However, the levels of serum CA125 had no significant difference in the 4 groups（P>0.05）.The levels of serum HE4 and CA125 had positive correlation［coefficient of correlation（r)=0.467 and 0.380，P<0.05］in the patients with ovarian cancer and intrauterine tumor, but there was no correlation among the other 3 groups. The positive rates of HE4 and CA125 in patients with ovarian cancer, intrauterine tumor, benign ovarian disease, benign uterus disease and the control group were 100.00％, 71.43％; 37.50％, 30.00％; 14.70％, 11.76％; 19.23％, 32.69％ and 2.32％, 2.32％ respectively. The sensitivities of HE4 and CA125 to ovarian cancr were 100.00％ and 71.43％，the specificities were 82.35％ and 85.29％，the positive predictive values were 53.85％ and 50.00％，and the negative predictive values were 100.00％ and 93.50％. The area under the receiver operating characteristic(ROC) curve（AUC）of HE4 was bigger than that of CA125 in patients with ovarian cancer（P<0.01）. Merging the ovarian cancer group and the intrauterine tumor group as pelvic malignant lesion group, the diagnostic sensitivities of HE4, CA125 and HE4+CA125 were 46.80％, 36.17％ and 54.41%，the specificities were 82.60％, 75.58％ and 47.22%, the positive predictive values were 59.50％, 44.74％ and 49.33%，and the negative predictive values were 74.00％, 68.42％ and 52.31%. Conclusions　Besides the serum level of HE4 is helpful in the diagnosis of ovarian cancer and intrauterine tumor， the levels of HE4 will increase in a part of benign gynecological pelvic lesion.

Key words: Human epididymis protein 4, Ovarian tumor, Gynecological pelvic lesion, Tumor marker