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目的探讨人附睾分泌蛋白4(HE4)及卵巢恶性肿瘤风险(ROMA)值在中国人群上皮性卵巢癌的诊断和卵巢癌风险评估中的应用价值。方法应用酶联免疫吸附试验(ELISA)法检测206例上皮性卵巢癌、子宫良性疾病,子宫内膜癌,卵巢良性疾病患者血清中HE4水平,选64例卵巢癌患者为恶性肿瘤组,57例良性卵巢肿瘤患者及60例健康者为对照组。经测定血清糖类抗原125(CA125)水平后,带入公式计算其ROMA值,结合绝经状态评价诊断和患卵巢癌的风险性。结果上皮性卵巢癌组患者HE4水平明显高于对照组、子宫良性疾病组、子宫内膜癌组及卵巢良性疾病组的患者,差异均有统计学意义(P<0.05)。经受试者工作特性曲线(ROC)分析,HE4的ROC曲线下面积为0.827,以150pmol/L为界值时,检测卵巢癌的灵敏度和特异度达73.4%和89.5%。由ROMA值结合绝经状态在121例患者中诊断出卵巢癌的敏感度和特异度分别为87.5%和77.2%,未绝经患者高危组罹患卵巢癌的风险是低危组的9.6倍;绝经患者高危组罹患卵巢癌的风险是低危组的3.8倍,绝经前后高风险间差异有统计学意义(P<0.01)。阳性预测值和阴性预测值分别为81.2%和88.0%。结论 HE4可作为临床诊断上皮性卵巢癌新的肿瘤标志物,ROMA值的计算有望成为评估患者上皮性卵巢癌风险的一种新的辅助手段。
Objective To investigate the value of human epididymis secretory protein 4 (HE4) and ovarian cancer risk (ROMA) in the diagnosis of ovarian cancer and ovarian cancer risk assessment in Chinese population. Methods The serum levels of HE4 in 206 patients with epithelial ovarian cancer, benign uterine disease, endometrial cancer and benign ovarian disease were detected by enzyme-linked immunosorbent assay (ELISA), 64 patients with malignant ovarian cancer and 57 patients Benign ovarian cancer patients and 60 healthy controls were control group. After the level of serum carbohydrate antigen 125 (CA125) was measured, its ROMA value was calculated and the risk of diagnosis and ovarian cancer was evaluated in combination with menopausal status. Results The level of HE4 in epithelial ovarian cancer patients was significantly higher than that in control group, benign uterine disease group, endometrial cancer group and benign ovarian disease group (all P <0.05). The receiver operating characteristic curve (ROC) analysis showed that the area under the ROC curve of HE4 was 0.827, and the sensitivity and specificity of detecting ovarian cancer at the level of 150 pmol / L reached 73.4% and 89.5%, respectively. The sensitivity and specificity of diagnosing ovarian cancer in 121 patients by ROMA combined with menopause were 87.5% and 77.2%, respectively. The risk of ovarian cancer in high-risk patients without menopause was 9.6 times that in patients with low risk; the risk of menopause The risk of ovarian cancer was 3.8 times that of the low risk group, and there was a significant difference between the high risk before and after menopause (P <0.01). The positive predictive value and negative predictive value were 81.2% and 88.0% respectively. Conclusion HE4 can be used as a new tumor marker in clinical diagnosis of epithelial ovarian cancer. The calculation of ROMA value is expected to be a new adjunct to evaluate the risk of epithelial ovarian cancer in patients.