血清HE4及CA125水平检测在早期卵巢恶性肿瘤诊断中的价值

目的探讨血清人附睾蛋白4（HE4）及癌抗原125（CA125）水平检测在早期卵巢恶性肿瘤诊断中的价值。方法用酶联免疫吸附试验方法（ELISA）测定150例女性血清HE4、CA125水平,其中卵巢恶性肿瘤组（45例）、卵巢良性病变组55例及健康女性50例,分析两指标单独或联合检测诊断卵巢恶性肿瘤的价值。结果①卵巢恶性肿瘤组血清HE4和CA125水平（分别为344.66±256.37 pmol/L和516.07±609.07 U/ml）,分别与卵巢良性病变组（分别为53.77±19.03 pmol/L和41.17±62.08 U/ml）和正常组（分别为39.06±16.17 pmol/L和10.36±7.28 U/ml）比较,差异均有显著性（P〈0.001）;②根据ROC曲线,当HE4在80 pmol/L时诊断指数最大（0.806）,灵敏性和特异性分别为84.4%和92.4%,ROC曲线下面积0.948（95%CI 0.900～0.997,P=0.000）;③卵巢良性病变组血清HE4单项检测的假阳性率（5.5%）明显低于血清CA125单项检测的假阳性率（21.8%,P=0.012）;④HE4对早期卵巢癌的检测阳性率（73.3%）高于CA125检测的阳性率（33.3%,P=0.031）;⑤HE4单项检测对卵巢癌预测的特异度、阳性预测值（分别为94.6%和93.2%）高于CA125单项检测的特异度、阳性预测值（分别为78.2%和72.7%,P〈0.05）。联合CA125和HE4作为卵巢癌的诊断指标时,其诊断灵敏度为88.9%,高于单项血清CA125检测灵敏度（P〈0.05）。结论 HE4可作为卵巢癌诊断的独立生物学指标,其对早期卵巢癌的诊断价值优于CA125,两者联合检测可以提高CA125对卵巢癌的诊断能力。血清HE4水平以80 pmol/L为界值点对卵巢恶性肿瘤的诊断指数最大。

The value of serum human epididymis secretory protein 4 and CAl25 assay in the diagnosis of early stage ovarian malignancy

Objective To evaluate the value of detection of human epididymis secretory protein 4（HE4）and CA125 in the diagnosis of early-stage ovarian malignancy.Methods HE4 and CA125 in the serum specimens of malignant ovarian tumor group（45 cases）,benign ovarian diseases group（55 cases） and healthy women group（50 cases） were ascertained by enzyme-linked immunosorbent assay（ELISA）.The levels and the diagnosis efficiency of HE4 and CA125 were analyzed.Results ①The levels of HE4 and CAl25 were significantly higher in malignant ovarian tumor group（344.66±256.37 pmol/L and 516.07±609.07 U/ml,respectively） than those in the benign ovarian diseases group（53.77±19.03 pmol/L and 41.17±62.08 U/ml,respectively） and healthy women group（39.06±16.17 pmol/L and 10.36±7.28 U/ml,respectively）（P0.001）.②The diagnosis efficiency of HE4 assay at the level of 80 pmo1/L determined in ROC curve had the most significant diagnostic index（0.806）,with a sensitivity of 84.4% and a specificity of 92.4%.The area under the ROC curve was 0.948（95% CI 0.900～0.997,P=0.000）.③The false positive rate of HE4 was lower than that of CA125 in benign diseases group（P=0.012）.④ The positive rate of HE4 was higher than that of CA125 in early-stage malignant ovarian tumor group（P=0.031）.⑤The specificity and positive predictive value of HE4 assay were 94.6% and 93.2%,which were higher than those of CA125 assay（78.2% and 72.7%）（P0.05）.Combination of CA125 and HE4 had the highest sensitivity of 88.9% which was higher than CA125 assay alone（P0.05）.Conclusions HE4 seems to be a promising ovarian cancer marker.As a single tumor marker,HE4 had the highest sensitivity for detecting early-stage ovarian cancer.The set point of 80pmol/L is advantageous for the screening of malignant ovarian cancer.Combination of CA125 and HE4 is a more accurate predictor of malignancy than CA125 alone.