目的 探讨复方苦参注射液联合ET方案（表柔比星联合多西他赛）治疗乳腺癌的临床疗效。方法 选取2016年1月—2017年12月邳州市中医院收治的94例晚期乳腺癌患者作为研究对象，将所有患者随机分为对照组和治疗组。每组各47例。对照组患者给予ET方案治疗，静脉滴注注射用盐酸表柔比星70 mg/m²，连续3 d，4周后重复1次；静脉滴注多西他赛注射液75 mg/m²，1次/周，连用6周，停2周。治疗组患者在对照组治疗的基础上第1～10天静脉滴注复方苦参注射液，20 mL用氯化钠注射液200 mL稀释。8周为1个疗程，两组患者均治疗2个疗程。观察两组近期临床疗效，比较两组患者的无进展生存期（PFS）、总生存期（OS）、生存质量测定量表简表（QOL-BREF）评分、肿瘤标志物和免疫因子水平。结果 治疗后，对照组的临床缓解率为38.3%，疾病控制率为72.3%，分别显著低于治疗组的57.4%、89.4%，两组比较差异具有统计学意义（P<0.05）。治疗后，治疗组患者的PFS、OS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，治疗组的QOL-BREF评分显著升高，同组比较差异具有统计学意义（P<0.05），且治疗后治疗组QOL-BREF评分显著高于对照组，两组比较差异具有统计学意义（P<0.05）。治疗后，两组血清癌胚抗原（CEA）、糖类抗原153（CA153）和糖类抗原125（CA125）水平均显著降低，同组治疗前后比较差异具有统计学意义（P<0.05）；且治疗后治疗组的肿瘤标志物水平均显著低于对照组，两组比较差异具有统计学意义（P<0.05）。治疗后，治疗组的CD3⁺、CD4⁺和CD4⁺/CD8⁺水平均显著升高，CD8⁺水平显著降低，同组治疗前后比较差异具有统计学意义（P<0.05）；且治疗后治疗组免疫因子水平显著优于对照组，两组比较差异具有统计学意义（P<0.05）。结论 复方苦参注射液联合ET方案治疗晚期乳腺癌疗效确切，能降低肿瘤标志物水平，提高免疫功能，延长患者PFS和OS，提高患者生活质量，具有一定的临床推广应用价值。

Objective To explore the clinical effect of Compound Kushen Injection combined with ET regimen (epirubicin and docetaxel) in treatment of breast cancer. Methods Patients (94 cases) with breast cancer in Pizhou Hospital of Traditional Chinese Medicine from January 2016 to December 2017 were randomly divided into control and treatment groups, and each group had 47 cases. Patients in the control group were given ET regime, and were iv administered with Epirubicin Hydrochloride for injection 75 mg/m² for 3 d, and repeated every 4 weeks. And patients in the control group were also iv administered with Docetaxel Injection 75 mg/m², once weekly for 6 weeks, and stopped for 2 weeks. Patients in the treatment group were iv administered with Compound Kushen Injection on the basis of control group on the first to tenth day, and 20 mL was diluted with 200 mL sodium chloride injection. A course of treatment had 8 weeks, and patients in two groups were treated for 2 courses of treatment. After treatment, the short-term clinical efficacy was evaluated, and the PFS, OS, QOL-BREF score, tumor markers and immune factors levels in two groups were compared. Results After treatment, the clinical remission rate and disease control rate in the control and treatment groups were 38.3% and 72.3%, respectively, which were significantly lower than 57.4% and 89.4% in the treatment group, there were differences between two groups (P<0.05). After treatment, PFS and OS in the treatment group were significantly higher than those in the control group, and there were differences between two groups (P<0.05). After treatment, QOL-BREF score in the treatment group were significantly increased, and there were differences in the same group (P<0.05). And QOL-BREF score in the treatment group after treatment was significantly higher than that in the control group, and there were differences between two groups (P<0.05). After treatment, the levels of CEA, CA153, and CA125 in two groups were significantly decreased, and there were differences in the same group (P<0.05). And the tumor markers levels in the treatment group were significantly lower than those in the control group, and there were differences between two groups (P<0.05). After treatment, the levels of CD3⁺, CD4⁺, and CD4⁺/CD8⁺ in two groups were significantly increased, but the CD8⁺ level was decreased, and there were differences in the same group (P<0.05). And the immune factors levels in the treatment group were significantly better than those in the control, and there were differences between two groups (P<0.05). Conclusions Compound Kushen Injection combined with ET regimen has a definite therapeutic effect in treatment of breast cancer, can reduce the level of tumor markers, improve immune function, prolong PFS and OS, and improve the quality of life, which has a certain clinical application value.