目的探讨乳腺癌HER-2基因扩增状况与临床病理特征的相关性。方法采用荧光原位杂交(FISH)方法检测165例乳腺癌石蜡标本的HER-2基因扩增状况,分析基因扩增状况与临床病理特征之间的关系。结果全组HER-2基因扩增阳性52例(31.5%)。不同年龄、肿瘤大小、临床分期及病理类型组间HER-2基因扩增阳性率差异无统计学意义(P>0.05)。HER-2基因扩增阳性率在腋淋巴结转移组明显高于无淋巴结转移组(P<0.05),p53阳性组明显高于阴性组(P<0.05),ER、PR阳性组明显低于ER、PR阴性组(均P<0.01)。结论 HER-2基因扩增状况与年龄、肿瘤大小、临床分期及病理学类型无关相性,与腋淋巴结转移和p53基因表达成正相关,与ER、PR表达成负相关。HER-2基因可作为判断乳腺癌预后及拟订治疗方案的良好指标。 Objective To investigate the relationship between HER-2 gene amplification and clinicopathological features in breast cancer. Methods The amplification of HER-2 gene in 165 cases of breast cancer was detected by fluorescence in situ hybridization (FISH). The relationship between gene amplification and clinicopathological features was analyzed. Results The whole group of HER-2 gene amplification positive in 52 cases (31.5%). There was no significant difference in the positive rate of HER-2 gene amplification between different age, tumor size, clinical stage and pathological type (P> 0.05). The positive rate of HER-2 gene amplification in axillary lymph node metastasis group was significantly higher than that in no lymph node metastasis group (P <0.05), p53 positive group was significantly higher than negative group (P <0.05), ER, PR positive group was significantly lower than ER, PR negative group (all P <0.01). Conclusion There is no correlation between the amplification status of HER-2 gene and the age, tumor size, clinical stage and pathological type. It is positively correlated with axillary lymph node metastasis and p53 gene expression, but negatively correlated with ER and PR expression. HER-2 gene can be used as a good indicator to judge the prognosis of breast cancer and to formulate the treatment plan.