目的 探讨西黄丸联合来曲唑晚期乳腺癌治疗的临床效果。方法 选取2015年8月—2017年6月天津市第五中心医院和滨州市人民医院收治的114例晚期乳腺癌患者，随机分为对照组和治疗组，每组各57例。对照组口服来曲唑片，1片/次，1次/d。治疗组在对照组基础上口服西黄丸，3 g/次，2次/d。两组均连续治疗3个月。观察两组的临床疗效，比较两组治疗前后血清学指标、CD4⁺/CD8⁺比值、癌症治疗性功能评价量表-乳腺癌（FACT-B）的变化情况。随访1年，比较两组的生存率。结果 治疗后，对照组的客观缓解率、临床获益率分别是26.3%、56.1%；治疗组的客观缓解率、临床获益率分别是36.8%、75.4%，两组客观缓解率比较差异无统计学意义；治疗组临床获益率显著高于对照组，两组比较差异有统计学意义（P<0.05）。治疗后，两组血清雌酮（E₁）、雌二醇（E₂）水平较治疗前均显著降低，而外周血CD4⁺/CD8⁺比值均显著升高，同组治疗前后比较差异有统计学意义（P<0.05）；治疗后，治疗组血清E₁、E₂水平低于对照组，外周血CD4⁺/CD8⁺比值高于对照组，两组比较差异具有统计学意义（P<0.05）。治疗后，两组生理状况评分、情感状况评分、附加关注评分、社会/家庭状况评分、功能状况评分及总分均显著增加，同组治疗前后比较差异有统计学意义（P<0.05）；治疗后，治疗组这些FACT-B评分均显著高于对照组，两组比较差异具有统计学意义（P<0.05）。治疗后，两组血清糖类抗原15-3（CA15-3）、癌胚抗原（CEA）水平较治疗前均显著降低，同组治疗前后比较差异有统计学意义（P<0.05）；治疗后，治疗组CA15-3、CEA水平显著低于对照组，两组比较差异具有统计学意义（P<0.05）。随访1年，对照组和治疗组的生存率分别是42.1%、61.4%，两组比较差异具有统计学意义（P<0.05）。结论 西黄丸联合来曲唑治疗晚期乳腺癌具有较好的临床疗效，能有效稳定患者病情，抑制体内雌激素合成，纠正外周血T淋巴细胞亚群失衡，改善生活质量，提高生存率，具有一定的临床推广应用价值。

Objective To investigate the clinical effect of Xihuang Pills combined with letrozole in treatment of advanced breast cancer. Methods 114 Patients with advanced breast cancer in the Fifth Central Hospital of Tianjin and the People's Hospital of Binzhou from August 2015 to June 2017 were randomly divided into control (57 cases) and treatment (57 cases) groups. Patients in the control group were po administered with Letrozol Tablets, 1 tablet/time, once daily. Patients in the treatment group were po administered with Xihuang Pills on the basis of the control group, 3 g/time, twice daily. Patients in two groups were treated for 3 months. After treatment, the clinical efficacy was evaluated, and the changes of serological indicators, CD4⁺/CD8⁺, FACT-B score in two groups before and after treatment were compared. Follow-up for 1 year, the survival rates of the two groups were compared. Results After treatment, the objective remission rate and clinical benefit rate in the control were 26.3% and 56.1%, and in the treatment group were 36.8% and 75.4%, and there was no significant difference in objective remission rate between the two groups. The clinical benefit rate of the treatment group was significantly higher than that of the control group, and there were differences between two groups (P<0.05). After treatment, E₁ and E₂ in two groups were significantly deeased, but CD4⁺/CD8⁺ was significantly increased, and there were differences in the same group (P<0.05). After treatment, E₁ and E₂ in the treatment group were lower than those in the control group, but CD4⁺/CD8⁺ was higher than that in the control group, and there were differences between two groups (P<0.05). After treatment, physiological status score, emotional status score, additional attention score, social/family status score, functional status score and total score in two groups were significantly increased, and there were differences between two groups (P<0.05). After treatment, those FACT-B scores in the treatment group were higher than those in the control group, and there were differences between two groups (P<0.05). Follow-up for 1 year, the survival rates in the control and treatment group were 42.1%, 61.4%, and there were differences between two groups (P<0.05). Conclusion Xihuang Pills combined with letrozol has significant effect in treatment of advanced breast cancer, and can effectively stabilize the patient's condition, and also can inhibit the estrogen synthesis, and can correct the imbalance of peripheral blood T lymphocyte subsets, and improve the life quality and survival rate, which has a certain clinical application value.