两种方法检测血清人附睾分泌蛋白在盆腔疾病诊断中的研究
Diagnosis of pelvic tumors by detecting human epididymis secretory protein via two methods
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摘要:目的 探讨血清人附睾分泌蛋白(human epididymis protein 4, HE4)在盆腔疾病诊断及鉴别诊断中的应用价值, 比较电化学发光法(electrochemiluminescence immunoassay, ECLIA)及酶联免疫吸附法(Enzyme-linked immunosorbent assay, ELISA)检测人附睾分泌蛋白的诊断准确性。方法 采用ECLIA检测211例患者血清HE4水平, 包括85例卵巢癌、42例子宫内膜癌、21例子宫内膜异位症、33例盆腔良性疾病及30例健康对照者。结果以中位数表示, 分析血清HE4在盆腔疾病诊断及鉴别诊断中的意义, 并分别探明诊断卵巢癌及子宫内膜癌的最佳判定值。采用ELISA对其中卵巢癌组及卵巢良性疾病组血清HE4进行检测, 绘制受试者工作特征曲线(ROC), 计算曲线下面积(ROC-AUC), 比较两种方法鉴别诊断卵巢良恶性疾病的准确性。结果 卵巢癌组、子宫内膜癌组血清HE4水平显著高于健康对照组、卵巢良性疾病组及子宫内膜异位症组; 卵巢良性疾病组及子宫内膜异位症组与健康对照组比较, 无显著性差异; HE4在鉴别诊断卵巢良恶性疾病、子宫内膜良恶性疾病时, 其ROC-AUC分别为0.869和0.931, 最佳诊断点分别为86.02 pmol/L和74.6 pmol/L。以卵巢良性肿瘤组作为对照, ECLIA法及ELISA法检测卵巢癌患者血清HE4的ROC-AUC分别为0.869和0.794。结论 HE4在盆腔疾病的诊断及良恶性鉴别中具有较高的诊断价值, ECLIA法检测卵巢癌的诊断准确性优于ELISA法。Abstract:Objective This study aimed to evaluate the importance of human epididymis protein 4(HE4) in both simple diagnosis and differential diagnosis of pelvic diseases.This study also aimed to compare the diagnostic results of electro-chemiluminescence immunoassay(ECLIA) and enzyme-linked immunosorbent assay(ELISA).Methods HE4 in serum specimens of the following groups was subjected to ECLIA: malignant ovarian tumor(85 cases); endometrial cancer(42 cases); endometriosis(21 cases); benign ovarian disease(33 cases); and healthy women(30 cases).Median scores of these groups were compared.HE4 detected by simple diagnosis and differential diagnosis of pelvic tumors were analyzed.The most accurate interpretation of the diagnosis of ovarian and endometrial cancers was evaluated.To detect HE4 in the serum specimens of the groups with malignant ovarian tumor(85 cases) and benign ovarian diseases(33 cases), ECLIA and ELISA were performed, respectively.A receiver operating characteristic(ROC) curve was drawn and the area under the curve(AUC) was calculated.Benign and malignant ovarian tumors were also detected by the two methods and results were analyzed.Results The median scores of HE4 were significantly higher in malignant ovarian tumor and endometrial cancer groups than in healthy women, benign ovarian disease, and endometriosis groups.Ovarian benign disease and endometriosis groups did not have a significant difference compared with the healthy control group.For the differential diagnosis of benign and malignant ovarian tumors, ROC-AUC of HE4 was 0.869.For the differential diagnosis of endometrial benign and malignant disease, ROC-AUC of HE4 was 0.931.The most accurate interpretations of HE4 were 86.02 and 74.6 pmol/L.For HE4 detected by ECLIA and ELISA, the benign ovarian tumor group was considered as the control group.The ROC-AUCs of HE4 detected by ECLIA and ELISA were 0.869 and 0.794, respectively.Conclusion High diagnostic and differential diagnostic results of HE4 were observed in the benign and malignant pelvic disease groups.ECLIA was more effective than ELISA in detecting HE4 for the diagnosis of ovarian canner.
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