The Application Of Human Epididymis Protein 4 In Gynecological Bbenign Diseases

Object The human epididymis protein 4(HE4) is a novel biomarker for epithelialovarian cancer,which being in clinical application and promotion. This study used the HE4, cancer antigen125(CA125) and ROMA(Risk of Ovarian Malignancy Algorithm)levels in women with Benign and malignant gynecological disorders to find the meaning of those two biomakers.Methods Cases which had gynecological disorders and needed gynecological surgeries were selected from June 2014 to January 2016 in the First Affiliated Hospital of Shihezi University Medical College, and then got the postoperative pathological results. Serum CA125 and HE4 levels were obtained from the patients on preoperative 15 d in blood. The upper limit of normal serum CA125 was 35 U/ml;serum HE4 reference value is 105.10 pmol/L, the apparent healthy premenopausal and postmenopausal women HE4 cut-off values were 68pmol/L and 114 pmol/L. The apparent healthy premenopausal and postmenopausal women ROMA cut-off values were 14.99% and 36.31%. A comparative analysis of two biomarkers and ROMA in different diseases.Results1. All gynecologic benign diseases were divided into 4 groups of benign uterine disease,benign ovarian disease, pelvic inflammation and other benign diseases. The median of the 4 groups of CA125 and HE4 were not different(P<0.05).Uterine adenomyosis group CA125 levels were greater than of which uterine fibroids group and other uterine benign disease group(P < 0.05), and CA125 level of uterine fibroids group and other uterine benign disease group had no difference(P > 0.05).There was no difference in the HE4 of the uterine gland muscle group, the uterine leiomyoma group and other uterine benign disease group(P>0.05).CA125 levels of ovary uterine endometriosis cyst group were greater than the group of ovarian teratoma, ovarian cyst group and other ovarian benign tumor group(P < 0.05), there is no significance in the 3 groups of CA125 median(P >0.05). there was no significant difference between the other groups excepting between teratoma and epithelial cyst(P<0.05).2. The levels of CA125, HE4 and ROMA in malignant group were higher than those in benign group, and the difference was statistically significant(P<0.05).The ovarian cancerlevel of CA125, HE4, ROMA were higher than those of ovarian endometrial cyst(both P<0.05).3. There was no significant difference in CA125 level between the pre and post menopausal women with benign disease(P>0.05), but the HE4 level was significantly different(P<0.05).After the age group, there was no significant difference(P>0.05) between the different age groups of HE4 levels.4. HE4 cutoff value selected 105.10 pmol / L,and CA125 selected 35U/ml, the proportion of the promotion of HE4 and CA125 has statistical significance(P < 0.05).The percentage of HE4 in ovarian group increased the proportion is low than the percentage of CA125, the difference is statistically significant(P < 0.05).When premenopausal women HE4 cutoff values selected 68 pmol / L, postmenopausal women selected 114 pmol / L, CA125 reference value still is 35U/ml, the differences between uterine group and ovarian group of the elevate proportion of two markers was statistically significant(P < 0.05).Again pathologically subdivided group into myoma of uterus, ovarian endometriosis cyst and ovarian teratoma,the two tumor markers of those groups increased ratio difference is significant(P < 0.05).5. All non malignant diseases accounted for 87%, and malignant tumors accounted for only13% in all the diseases that cause CA125 elevation.When the value of 105.10pmol/L was higher than HE4, the non malignant diseases accounted for 42%, and malignant diseases accounted for 58% in all the diseases that cause HE4 elevation.When the cut-off value of HE4 was taken 68pmol/L for premenopause, 114pmol/L for postmenopause, and the non malignant diseases were 70% and malignant diseases accounted for 30% in all the diseases that cause HE4 elevation.All the non malignant diseases accounted for 64% and malignant diseases accounted for 36%, in which caused the increase of ROMA value.6. The sensitivity and negative predictive value of the four test methods, CA125, HE4,ROMA alone and combined with detection of CA125+HE4 alone were not statistically significant(P>0.05).There was significant difference in the specificity of these four methods except for HE4 and ROMA group(P>0.05).The AUC of the four methods were0.609, 0.803, 0.813 and 0.620.Conclusions1. The level of serum CA125 in the patients with uterine gland disease is higher than other uterine benign diseases and the level of serum HE4 is normal. It is helpful for identificating uterine gland muscle disease and other uterine benign diseases.2. Ovarian endometriosis cyst of serum CA125 levels and higher than other ovarian benign disease, but the HE4 levels in normal and with other ovarian benign disease no difference,which can help distinguish ovarian endometriotic cyst and ovarian benigndisease.3. In the gynecological benign disease, the proportion of the increase of serum HE4 is lower than that of the serum CA125, especially in the uterine fibroids, ovarian endometriosis cyst and ovarian.4. Evaluation of CA125, HE4, Roma and combined detection of CA125 and HE4 these four kinds of test methods did not increase the sensitivity and negative predictive value in the diagnosis of malignant disease. HE4 and Roma were in a certain extent improved the specificity and positive predictive value.