探讨血清人附睾蛋白4(HE4)和糖链抗原－125(CA₁₂₅)对卵巢癌的诊断价值。

选择2009年1月至2010年8月因盆腔包块于本院住院治疗的59例患者为研究对象。根据其术后病理学检查结果将其分为卵巢癌组(n＝29)和盆腔良性疾病组(n＝30)。选择同期在本院体检中心体检的37例健康妇女纳入对照组。分别采用酶联免疫分析法(ELISA)和化学发光免疫法(CLIA)测定3组受试者血清HE4和CA₁₂₅水平，应用受试者工作特性曲线(ROC)对HE4和CA₁₂₅水平的单项和联合检测结果进行统计学分析(本研究遵循的程序符合本院人体试验委员会制定的伦理学标准，得到该委员会批准，分组征得受试对象本人的知情同意，并与其签署临床研究知情同意书)。

卵巢癌组血清HE4和CA₁₂₅水平均明显高于其他两组，差异有统计学意义(P<0.01，P<0.05)；盆腔良性疾病组与对照组HE4水平比较，差异无统计学意义(P>0.05)。以盆腔良性疾病组ROC下的面积(AUC)为参照，其他两组HE4和CA₁₂₅水平的单一或两者联合检测的相对ROC AUC分别为0.924，0.793和0.931。HE4，CA₁₂₅诊断卵巢癌的临床诊断临界值分别为73.5 pmol/L和35 IU/mL。

HE4对卵巢癌有较高诊断价值。HE4联合CA₁₂₅检测有助于提高卵巢癌早期诊断的灵敏度和效率。

To investigate the diagnostic value of human epididymis protein (HE4) and carbohydrate antigen-125 (CA₁₂₅) in ovarian cancer.

From January 2009 to August 2010, 59 women with pelvic mass were included into this study. They were divided into two groups according to pathological examination after operation, ovarian cancer group (n=29) and pelvic benign diseases groups (n=30). Meanwhile, another 37 healthy women who had the physical examination during the same period were recruited into control group. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of West China Second University Hospital, Sichuan University. Informed consent was obtained from all participants. The single and combined detection of HE4 and CA₁₂₅ levels in the serum from three groups were quantitatively determined by enzyme-linked immunosorbent assay (ELISA) and chemiluminescence immunoassay (CLIA). At last, the area under curve (AUC) of the total results were evaluated by receiver operating characteristic curve (ROC).

Serum HE4 and CA₁₂₅ levels in ovarian cancer group were significantly higher than those in other two groups with statistically significant difference (P<0.01, P<0.05). There was no significant difference between pelvic benign disease group and control group in the serum HE4 level (P>0.05). Reference to benign disease group(AUC=1), the correspondence AUC by ROC of HE4, CA₁₂₅ and the both indexes were 0.924, 0.793 and 0.931, respectively, and the cut off value of HE4 and CA₁₂₅ in clinical diagnosis was 73.5 pmol/L and 35 IU/mL, respectively.

Combined detection of HE4 and CA₁₂₅ could improve the sensitivity and efficiency in the diagnosis of early ovarian cancer.