疏肝益肾方对激素依赖性乳腺癌的前瞻性队列研究

A prospective cohort study on hormone-dependant metastatic breast cancer treated with Shuganyishen formula

目的观察疏肝益。肾方对激素依赖性转移性乳腺癌患者的影响并从耐药机制角度进行探讨。方法采用队列研究的方法，依据治法将226例晚期激素依赖性乳腺癌意向人群分为2个队列，疏肝益肾方联合西医治疗队列及单纯西医治疗队列。疏肝益肾方，1剂／d，服药至少半年或至肿瘤进展；西医按照美国综合癌症治疗网（national comprehensive cancer network，NCCN）指南给予相应的治疗，全部患者均并用内分泌治疗。观察并记录患者的疾病进展时间（time to progress，TTP）生存期（overal survival，OS）及生存质量。通过动物实验观察了疏肝益肾方配合三苯氧胺对耐药瘤株的抑制作用。结果无论LuminalA型（ER＋／PR＋，HER2-）还是LuminalB型（ER＋／PR＋，HER2＋）乳腺癌，联合治疗组的中位TTP较单纯西药治疗组长，中位OS两组未见差异；潮热、汗出及骨相关病症的发生率及程度联合治疗组较单纯西药组低。体外实验显示，疏肝益肾方对耐药的TAM．R瘤株有很好的抑制作用。结论无论LuminalA型还是LuminalB型，疏肝益肾方联合西药治疗激素依赖性晚期乳腺癌可延长患者的无进展生存，提高生活质量。其作用机理可能与对化疗的增效及抑制内分泌耐药有关。

Objective Observing the effect of Shuganyishen formula on hormone-dependant metastatic breast cancer and the mechanisms of anti-resistance and endocrine therapy. Methods 226 ITT cases were divided into two cohorts by treatment. 126 cases were treated with the combination of ghuganyishen formula and standard western medicine including endocrine therapy, and 100 cases were treated with western medicine alone. The end points were time to progress （TTP） and overall survival and quality of life （QOF）. The effect of Shuganyishen formula on growth of TAM-resistance cell line in vitro was observed. Results There were statistical significances of median TTP between combination and western medicine in Luminal A （ER＋ /PR＋, HER2-） as well as Luminal B （ER＋/PR＋, HER2＋）, but no significances of OS; The extent and incidence of hot flush, sweat and syndromes related to bone were decreased significantly in combination treated group. Shuganyishen formula could reverse resistance to TAM. Conclusion Patients with LuminalA and LuminalB metastatic breast cancer benefit from Shuganyishen formula, which maybe related with its reverse resistance to endocrine therapy.