温肾健脾汤治疗激素依赖型乳腺癌疗效观察

Clinical Study of Warming Kidney and Strengthening Spleen Soup for Hormone-dependent Breast Cancer

目的:观察温肾健脾汤治疗激素依赖型乳腺癌的临床疗效及作用机制。方法:将48例激素依赖型乳腺癌患者按随机数字分配法分为单纯西医组(A组,20例)和联合治疗组(B组,28例)。两组患者均按照NCCN(National comprehensive cancer network)指南推荐的西医方法进行治疗,B组在西医治疗的基础上加用温肾健脾汤口服,每日1剂。两组疗程均为6个月或至疾病进展停药(半年内)。观察治疗前后雌二醇(E2)、促卵泡生成素(FSH)水平,日常生活质量评分,根据Kaplan-Meier法计算3年无进展生存期,同时评价两组药物治疗的不良反应。结果:两组患者治疗前E2、FSH、生存质量评分比较差异无统计学意义(P>0.05)。疗程结束后,两组患者的E2、FSH、生存质量评分均出现好转,差异有统计学意义(P<0.05);与A组相比,B组患者在E2、FSH、生存质量评分方面改善更加显著(P<0.05)。A组3年无进展生存期为(36.8±0.7)个月,B组为(32.4±1.3)个月,差异有统计学意义(P<0.05);而两组患者的OS比较差异无统计学意义;两组在不良反应发生率方面无明显差异(P>0.05)。结论:温肾健脾汤可以明显提高激素依赖型乳腺癌患者无进展生存期及总生存期,改善患者不适症状,提高患者生活质量,其机制可能与降低E2水平、提高FSH水平密切相关。

Objective：To observe the efficacy and safety of warming kidney and strengthening spleen soup for hormone-dependent breast cancer. Methods：48 patients with hormone-dependent breast cancer were randomly divided into western medicine group（A=20）and traditional Chinese medicine combined with western medicine group（B=28）. A group was treated with western medicine,B group was given with warming kidney and strengthening spleen soup and western medicine. E2,FSH,Chinese version of Short Form-36（SF-36）for living quality and progress-free survival were evaluated. And adverse reaction of both medicines was recorded simultaneously. Results：The results of E2,FSH,living quality in B group were significantly more improve than A group,the difference has significant respectively（P〈0.05）. And there was a statistically significance in B group by Kaplan-meier. The adverse rate in A group was the same with B group. Conclusion：Warming kidney and strengthening spleen soup can rapidly improve the progress-free survival,enhance patients＇ quality of life,and has lower incidence of adverse effects.