Objective To investigate the correlations of serum human mammaglobin(hMAM)levels with the early diagnosis of breast cancer and cancer micro-metastasis and their clinical significance.Methods By enzyme-linked immunosorbent assay(ELISA),the serum hMAM levels of 68 patients with breast cancer,40 patients with other cancers (1 0 patients with prostate cancer,1 0 patients with gastric cancer,1 0 patients with ovarian cancer and 1 0 patients with colorectal cancer),35 patients with benign breast disease and 40 healthy females (control group)were determined and analyzed comparatively.The 68 patients with breast cancer were classified according to TNM stage,whether existed the estrogen receptor (ER)expression,axillary lymph node metastasis and menopause.The cut-off value of serum hMAMin patients with breast cancer was determined by receiver operating characteristic (ROC)curve.Results The area under ROC curve of serum hMAM was 0.825,and the reliability in the diagnosis of breast cancer was 82.5% [95%confidence interval (CI):72.6%-92.4%].When the cut-off value for hMAM was 8.43 ng/mL,the sensitivity and specificity were 76.5% and 82.9%,respectively.Serum hMAM levels and positive rate in breast cancer group were significantly higher than those in benign breast disease group,other cancer group and control group (P<0.05 ).The difference among benign breast disease group,other cancer group and control group was not statistically significant (P>0.05).The positive rates of serum hMAM ofⅢ and Ⅳ breast cancer patients (55% and 75%)were significantly higher than those ofⅠand Ⅱpatients (25%and 40%,P<0.05),but hMAMlevels had no difference (P>0.05). The positive rate of serum hMAM in breast cancer patients with axillary lymph node metastasis (88%)was significantly higher than those without metastasis (30%,P<0.05),but hMAMlevels had no difference (P>0.05).Regardless of whether existed ER expression,proto-oncogene C-erb-2 expression and menopause,serum hMAM levels and positive rate of patients with breast cancer had no difference (P>0.05 ).Conclusions The hMAM expression is related with the clinical stage and axillary lymph node metastasis of breast cancer.The determination of serum hMAM level is helpful to improve the early diagnosis of breast cancer and early detection of cancer micro-metastasis.%目的：探讨血清人乳腺珠蛋白（hMAM）水平与乳腺癌早期诊断和癌微转移的相关性及其临床意义。方法应用酶联免疫吸附试验（ELISA）检测68例乳腺癌患者、40例其他癌症患者（前列腺癌、胃癌、卵巢癌、直肠癌各10例）、35例良性乳腺疾病患者以及40名体检正常女性（正常对照组）血清hMAM水平并做比较。将68例乳腺癌患者按临床TNM分期、是否存在雌激素受体（ER）表达、是否有腋窝淋巴结转移以及是否绝经分别分组并做比较。通过受试者工作特征（ROC）曲线确定乳腺癌血清hMAM的Cut-off值。结果血清hMAM的ROC曲线下面积为0．825，即诊断乳腺癌的可信度为82．5％[95％可信区间（CI）：72．6％～92．4％]；当hMAM的Cut-off值为8．43 ng/mL时，敏感性和特异性分别为76．5％、82．9％。乳腺癌组血清hMAM水平及阳性率明显高于良性乳腺疾病组、其他癌症组和正常对照组（P＜0．05），而良性乳腺疾病组、其他癌症组和正常对照组之间差异均无统计学意义（P＞0．05）。Ⅲ和Ⅳ期乳腺癌患者的血清hMAM阳性率（55％、75％）明显高于Ⅰ和Ⅱ期患者（25％、40％，P＜0．05），但hMAM水平无差异（P＞0．05）。有腋窝淋巴结转移的乳腺癌患者血清hMAM阳性率（88％）明显高于无转移的患者（30％，P＜0．05），但hMAM水平无差异（P＞0．05）。不管乳腺癌患者血清中是否存在ER、原癌基因C-erb-2表达及是否绝经，其hMAM水平及阳性率均无差异（P＞0．05）。结论 hMAM的表达与乳腺癌临床分期和是否有腋窝淋巴结转移相关；检测乳腺癌高危人群血清hMAM水平有助于提高乳腺癌的早期诊断和癌微转移的早期发现。
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