辨证中药治疗三阴性乳腺癌术后疗效的临床研究

Efficacy of traditional Chinese medicine with syndrome differentiation in the treatment for postoperative recurrence and metastasis of triple negative breast cancer

目的观察辨证中药治疗对三阴性乳腺癌术后化疗患者无病生存期的影响。方法选取三阴性乳腺癌根治术后化疗患者110例,随机分为治疗组(54例)和对照组(56例)。治疗组辨证服用中药治疗,对照组无针对相关疾病的治疗,常规随访,两组患者均定期复查。通过Cox模型对8个可能对三阴性乳腺癌术后无病生存期的影响因素进行多因素分析。结果治疗组及对照组的有效病例均为50例,治疗组3年无病生存率为78%,平均无病生存期(DFS)为(33.14±6.73)个月,均显著高于对照组的56%和(29.98±8.55)个月,差异均具有统计学意义(P﹤0.05)。多因素分析结果显示与三阴性乳腺癌无病生存期有关的因素为治疗方式和淋巴结转移状态(P﹤0.05)。治疗方式对应的回归系数为0.615,标准误为0.304,P值为0.040,相对危险度为1.863;淋巴结转移对应的回归系数为1.974,标准误为0.378,P﹤0.01,相对危险度为7.284。结论辨证口服中药治疗能有效提高三阴性乳腺癌患者术后无病生存率,延长无病生存期。

Objective To observe the impact of traditional Chinese medicine （TCM） with syndrome differentiation in patients with triple-negative breast cancer （TNBC） who had postoperative recurrence and metastasis. Method 110 patients with TNBC who had postoperative chemotherapy after radical mastectomy were enrolled and randomized into study group （n=54） or control group （n=56）. The study group was given TCM with syndrome differentiation, while the control group was administered with routine follow up without disease-targeted treatment, and both groups were regularly checked. Eight factors that might have potential affect on the recurrence and metastasis of TNBC after operation were selected and analyzed by Cox model. Result There were 50 eligible cases in either group. The 3-disease-free survival rate was 78% and the average disease-free survival （DFS） was （33.14±6.73） months in study group, compared with the 56% and （29.98±8.55） months in the control group, with statistically significant difference observed （P〈0.05）. With the multi-variate analysis using Cox model, the factors related to the DFS were obtained, including the ＂treatment modality＂ and ＂lymph node metastasis status＂ （P〈0.05）. The regression coefficient of treatment modality was 0.615, standard error （SE）=0.304, P=0.040, relative risk （RR）=1.863; For lymph node metastasis, regression coefficient= 1.974, SE=0.378, P=0, RR=7.284. Conclusions Oral administration of traditional Chinese medicine with syndrome differentiation may effectively improve the disease-free survival rate, while delay disease progression for patients with triple-negative breast cancer.