目的：探讨乳腺癌患者血清HER2水平与组织HER2水平和临床病理特征的关系，分析其对患者治疗药物选择和预后预测的意义。方法：选择福建省肿瘤医院2008年1月至10月经病理证实的乳腺癌患者67例，乳腺良性肿瘤患者20例，另选择体检健康女性20例。应用免疫组织化学方法检测乳腺癌组织HER2的表达，ELISA法检测血清HER2的表达水平。结果：乳腺癌患者血清HER2水平及阳性率均高于健康女性及乳腺良性肿瘤患者（P<0.05）；组织HER2阳性乳腺癌患者血清HER2水平及阳性率均高于组织HER2阴性乳腺癌患者（P<0.05），且血清HER2阳性率与组织HER2表达状态正相关，血清学检测方法与组织学检测方法一致性较好；部分组织HER2阴性乳腺癌发生复发转移后血清HER2增高，复发转移性Ⅳ期患者血清HER2阳性率高于Ⅰ〖DK〗～Ⅲ期患者（P<0.05）。结论：乳腺癌患者中血清HER2水平增高，其阳性率与组织HER2表达状态及临床分期相关，该检测对乳腺癌的诊断、评价HER2状态及判断预后有一定意义。

Objective: To study HER2 levels in the serum and breast cancer tissues and their correlation with clinical parameters, so as to explore drugs selection and prognosis prediction of breast cancer. Methods: Sixtyseven pathologicallyconfirmed breast cancer patients, 20 patients with breast benign tumor, and 20 healthy women, who were treated in Fujian tumor hospital from Jan. 2008 to Oct. 2008 were included in this study. Expression of HER2 in breast cancer tissues was examined by immunohistochemistry, and serum HER2 level in breast cancer patients was examined by ELISA. Results: Serum level and positive rate of serum HER2 in breast cancer patients were significantly higher than those in healthy women and breast benign tumor patients (P<0.05). Serum HER level and positive rate of serum HER2 in histological HER2 positive breast cancer patients were significantly higher than those in histological HER2 negative patients (P<0.05), with the positive rate of serum HER positively correlated with histological HER2 status. The result of serological method was consisted well with the histological method in the determination of HER2 status in breast cancer patients. Serum HER2 level in some histological HER2 negative primary breast cancer patients was increased after recurrence and metastasis, and positive rate of serum HER2 in Ⅳ metastatic breast cancer patients was significantly higher than that in ⅠⅢ metastatic breast cancer patients (P<0.05). Conclusions: Serum HER2 level is elevated in breast cancer patients, and positive rate of serum HER2 is correlated with histological HER2 status and clinical stages of cancer. Determination of serum HER2 may be useful in diagnosis, HER2 status evaluation and prognosis prediction of breast cancer patients.

福建省医学创新课题（No.2007CXB1)