中医辨证治疗乳腺癌术后高危人群的疗效评价

目的 观察中医辨证治疗对乳腺癌术后复发转移高危人群的疗效，评价中医辨证治疗对乳腺癌高危患者生存率及生存期的影响。方法 采用前瞻性队列研究设计，将接受规范化中医辨证治疗作为暴露因素，以ⅡA～ⅢC期乳腺癌术后复发转移高危患者作为研究对象，按照治疗方法将受试者分为中西医结合队列（中药+内分泌治疗）、中医队列（中医治疗）、西医队列（内分泌治疗）和观察队列，比较4队列累计无病生存率、总生存率及无病生存期（DFS）和总生存期（OS）情况。结果 中西医结合队列、中医队列、西医队列1、2、3年累计无病生存率均高于观察队列，差异有统计学意义（P＜0.05）。4个队列的累计总生存率差异无统计学意义（P＞0.05）。截至随访结束，354例受试者中共有65例乳腺癌术后高危患者发生复发转移、8例死亡，中西医结合队列、中医队列、西医队列、观察队列复发转移患者的中位DFS分别为17.00个月（95％CI：13.97～25.41个月）、16.87个月（95％CI：9.8～40.8个月）、13.93个月（95％CI：10.9～25.61个月）、12.61个月（95％CI：10.41～14.45个月），4队列复发转移患者的DFS差异无统计学意义（P＞0.05）。4队列中ⅢB～ⅢC期患者的累计无病生存率比较，差异有统计学意义（P＜0.05）；其中中西医结合队列、中医队列、西医队列患者的累计无病生存率均高于观察队列患者，差异有统计学意义（P＜0.05）；4队列各肿瘤分期患者累计总生存率的差异无统计学意义（P＞0.05）。结论 中医辨证治疗可提高激素受体阴性乳腺癌术后高危患者的累计无病生存率，尤其是肿瘤分期为ⅢB～ⅢC期的高危患者。无论接受何种治疗方法，尚不能在短期内明显延长乳腺癌高危患者的DFS和OS。

Clinical evaluation on traditional Chinese medicine treatment for breast cancer patients with high risks of recurrence and metastasis

Objective To observe the efficacy of traditional Chinese medicine（TCM） syndrome differentiation treatment for breast cancer patients with high risks of recurrence and metastasis. To evaluate the TCM treatment's influences of survival and survival rates in these high risk patients. Methods By using prospective cohort study， taking standardization of TCM syndrome differentiation treatment as exposed factors， patients with high risks breast cancer staged ⅡA to ⅢC were selected. The subjects were divided into 4 queues： TCM combination with western medicine queue （accepted TCM syndrome differentiation treatment and endocrine therapy）， TCM queue （accepted TCM syndrome differentiation treatment only）， western medicine queue （accepted hormone therapy only） and observation queue （didn't accept therapy）. To compare the four queues' accumulative disease-free survival （DFS） rates， accumulative overall survival （OS） rates， median DFS and OS. Results The 1-， 2- and 3-year accumulative disease-free survival rates of TCM combination with western medicine queue， western medicine queue and TCM queue were higher than observation queue's， and the difference was statistically significant（P＜0.05）.The accumulative overall survival rates of four queues had no statistical differences（P＞0.05）.To the end of the follow up， in 354 postoperative breast cancer patients with high recurrence metastasis risks， 65 patients were relapsed or with metastasis， 8 were dead. The median DFS of patients with recurrence and metastasis in TCM combination with western medicine queue， TCM queue， western medicine queue and observation queue was respectively 17.00 months（95％CI：13.97-25.41）， 16.87 months（95％CI：9.8-40.8）， 13.93 months（95％CI：10.9-25.61） and 12.61 months（95％CI：10.41-14.45）. There was no statistically significant difference of median DFS in four queues patients with recurrence or metastasis. The difference of the 1-， 2- and 3-year accumulative disease free survival rates in four queues patients staged ⅢB to ⅢC was statistical significance（P＜0.05）. Among them， the accumulative disease free survival rates of TCM combination with western medicine queue， western medicine queue and TCM queue were higher than observation queue's， and the difference was statistically significance（P＜0.05）. It was no statistically significance in four queues accumulative verall survival at each tumor stage（P＞0.05）. Conclusion TCM based on syndrome differentiation can improve the accumulative disease-free survival rates of hormone receptor negative and postoperative breast cancer patients at high risks of recurrence or metastasis， especially for patients with cancer stage ⅢB to stage ⅢC. No matter what kind of treatment， it is not obvious in the short term prolong disease free survival or overall survival in these patients.