Objective:To compare the expression of Serum Human Epididymis Protein 4(S-HE4),Urine Human Epididymis Protein 4(U-HE4)and serum CA125 between Ovarian Cancer(OC)group,Ovrian Benign Tumor(OBT)group and the Healthy Control(HC)group.To explore the Screening value of U-HE4 in ovarian cancer,in order to find a simpler,non-invasive new tumor marker.Methods:Serum CA125,S-HE4 and U-HE4 were detected by electrochemiluminescence immunoassay(ECLIA),and the ratio of urine to serum HE4(Ratios of urinary-to-serum HE4,R-HE4)was calculated.The expression of the markers in the HC,OBT and OC groups was determined by the Receiver Operator Characteristic Curve(ROC)curve to determine the optimal cutoff value for U-HE4 and R-HE4 in the diagnosis of ovarian cancer.Statistical analysis was performed using SPSS 20.0statistical software.Results: 1.The expression levels of each marker in different groups: S-HE4 and serum CA125 were significantly higher in the OC group than in the OBT group and the HC group,the difference was statistically significant(P<0.05),but the two were in the OBT group and HC.There was no significant difference in expression levels between the groups.The expression levels of U-HE4 in the three groups were significantly different(P<0.05),and the expression levels of R-HE4 in the OC group and OBT group were compared with HC.There were significant differences in the group(P<0.05),but there was no significant difference between the OBT group and the CC group.2.The efficacy of each marker in diagnosing ovarian cancer: U-HE4 is the most accurate in the diagnosis of ovarian cancer.The area under the ROC curve(AUC)is0.967,and the sensitivity(SEN)is 90.0%,speccificity(SPE)was 94.4%,Positive Predict Value(PPV)was 84.4%,Negative Predict Value(NPV)was 96.6%,and diagnostic coincidence rate was 93.3%.3.Differential diagnostic efficacy of each marker: U-HE4 is superior to S-HE4,serum CA125 and R-HE4 in the identification of OC and OBT,OC and HC,of which the optimal cutoff value(OC Vs.OBT)13151mmol/l(95% confidence interval(CI):0.939-0.995),the corresponding SEN and SPE are: 90.0% and 94.4%,respectively;the optimal cutoff value(OC Vs.HC)is 12461mmol/l(95% CI: 0.984-1.000),its SPE is 100%,and SEN is 90.0%.R-HE4 has the highest diagnostic accuracy in the identification of OBT and HC,with an AUC of 0.879,an optimal cutoff of 110.74(95% CI: 0.807-0.952),a corresponding SPE of 90.0%,and SEN of 78.3%.4.Diagnostic efficacy of a combination of two markers: the consistency of the two-two combination of markers and the diagnosis of the disease is represented by the Kappa coefficient,where Kappa(S-HE4 & U-HE4)is 0.885,Kappa(serum CA125 &U-HE4)It was 0.835 and Kappa(S-HE4 & serum CA125)was 0.8393.5.There was a significant difference in the expression level of S-HE4 in the OC group between menopausal and non-menopausal patients,P=0.006.When the optimal cut-off value was 112.10 and the AUC was 0.795(95% CI: 0.629-0.960),the SEN and SPE of S-HE4 in identifying ovarian cancer patients with menopause and non-menopausal status were 92.9% and 68.7%,respectively.6.The distribution of age in the OC group was significantly different from that in the OBT group.S-HE4 was associated with age,with a correlation coefficient of r=0.283.Conclusion: 1.U-HE4 is expected to be a new non-invasive,economical,simple and reproducible tumor marker for the screening of ovarian cancer,When combined with S-HE4 & U-HE4 to screen ovarian cancer,the Kappa coefficient was 0.885,which was highly consistent with the results of the disease test;2.R-HE4>119.51,can be used as a shunt marker for patients with ovarian tumors who need further examination.3.The expression level of S-HE4 in ovarian cancer patients was significantly correlated with the menopausal status of patients.4.The expression level of S-HE4 increases with age. |