摘要
背景与目的:人附睾上皮分泌蛋白4(human epididymis protein,HE4)是近年来研究较热门的一种新型肿瘤标志物,并拟在中国临床上推广应用,但目前国内HE4在卵巢癌应用研究中报道的例数还很少,特别是在随访监测中的价值尚待探究。本研究扩大了样本量,进一步探讨HE4在中国人群上皮性卵巢癌(epithelial ovarian cancer,EOC)的早期诊断、疗效监测以及预后判断中的应用价值。方法:应用酶联免疫吸附测定(enzyme-linked immunosorbent assay,ELISA)法检测116例EOC患者、40例卵巢良性疾病患者、61例其他肿瘤患者及100名健康对照者血清的HE4浓度水平,同时对其中28例EOC患者进行随访测定HE4水平。结果:未绝经组和绝经组中,EOC患者血清的HE4水平均明显高于健康对照和卵巢良性疾病患者(chi-square值分别为32.2和64.4,P均<0.01);根据健康对照组的P95(percent95)值,未绝经者HE4检测卵巢癌的Cut-off值为58.2pmol/L,敏感度为57.5%,特异度为93.9%;绝经者HE4检测卵巢癌的Cut-off值为67.6pmol/L,敏感度为80.3%,特异度为86.4%。卵巢癌患者血清HE4水平随着肿瘤分级、分期的升高而升高,淋巴结转移患者HE4水平显著高于未转移者(U值为665.5,P均<0.01)。此外,随访检测了28例EOC患者的血清样本,HE4浓度的变化能很好地反映疾病发展趋势(chi-square值为26.6,P<0.01);结果分析表明,HE4浓度变化与病情发展间的符合率为82.2%(23/28)。手术治疗后,病情好转者,HE4水平有所下降(21/25)。结论:HE4检测在EOC诊断和疗效监测、预后判断等方面具有较好的应用价值。
Background and purpose:Human epididymis protein 4 (HE4) is a new and promising biomarker which has recently become popularly applied in clinical detection.In China,few cases have been reported for HE4 determination in epithelial ovarian cancer (EOC) patients.The aim of this study was to further investigate the role and feasibility of HE4 determination on a larger scale in terms of EOC early diagnosis,treatment monitoring and prognosis evaluation.Methods:HE4 was determined by ELISA in 116 EOC patients,40 benign ovarian disease patients,100 health controls and 61 other non-EOC cancer patients.The HE4 concentrations of 28 EOC patients were followedup and analyzed.Results:Levels of HE4 were signifi cantly higher in EOC patients than ones in the health controls group or in benign ovarian disease patients in the premenopausal and postmenopausal groups (chi-square value is 32.2 and 64.4,P0.01,respectively).According to the P95 in the health controls group,the cut-off value for discriminating against patients from being a control in the premenopausal women group was established at 58.2 pmol/L for HE4 (sensitivity 57.5%;specificity 93.9%) whereas the corresponding cut-off value in post-menopausal women group was set at 67.6 pmol/L (sensitivity 80.3%;specifi city 86.4%).The level of HE4 was elevated with the progression of ovarian carcinoma.HE4 concentration was higher in patients with lymph node metastasis than those without metastasis (U=665.5,P0.01).Changes in the serial concentration of HE4 correlated with tumor therapy response (chi-square value is 26.6,P0.01) and coincidence rate was 82.2% (23/28).In addition,a decreased level of HE4 was found in patients who underwent surgical therapy (21/25).Conclusion:HE4 determination is helpful for disease diagnosis,therapy monitoring and prognosis evaluation in EOC patients.
出处
《中国癌症杂志》
CAS
CSCD
北大核心
2010年第9期680-685,共6页
China Oncology
基金
上海市卫生局基金资助(基金编号:2008Y114)