目的 探讨榄香烯注射液联合TAC方案（多西他赛、环磷酰胺联合多柔比星）治疗中晚期乳腺癌的临床疗效。方法 选取2015年1月-2017年12月在天津医科大学肿瘤医院治疗的105例中晚期乳腺癌患者，根据患者住院病历号末尾奇偶数分为对照组（49例）和治疗组（56例）。对照组患者接受TAC化疗方案：静脉滴注多西他赛注射液，75 mg/m²，静脉注射注射用环磷酰胺，500 mg/m²加生理盐水20~30 mL；静脉注射注射用盐酸吡柔比星，60 mg/m²加入5%葡萄糖注射液10 mL溶解。治疗组患者在对照组治疗的基础上静脉滴注榄香烯注射液，0.4~0.6 g/次，1次/d。每个化疗周期为21 d，两组患者持续6个化疗周期。观察两组临床疗效，比较两组的免疫功能、毒性反应、生存质量和预后。结果 治疗后，治疗组总有效率（44.64%）明显高于对照组（26.53%）（P<0.05）。治疗后，两组躯体功能（PF）、认知功能（CF）、总健康状况（QL）评分较治疗前升高（P<0.05）；且治疗后治疗组PF、CF、QL评分明显高于对照组（P<0.05）。治疗后，治疗组CD3⁺、CD4⁺较治疗前升高，CD8⁺较治疗前降低（P<0.05）；对照组CD8⁺较治疗前降低（P<0.05）；治疗后，治疗组CD3⁺、CD4⁺明显低于对照组（P<0.05）。治疗后，治疗组免疫球蛋白G（IgG）、免疫球蛋白M（IgM）水平较治疗前升高（P<0.05）；且治疗组IgG、IgM水平明显高于对照组（P<0.05）。治疗后，两组毒性反应比较无显著性差异。治疗组中位无进展生存时间（14个月）明显长于对照组（10个月），治疗组总生存时间（22个月）明显长于对照组（17个月），差异比较有统计学意义（P<0.05）。结论 榄香烯注射液联合TAC方案治疗中晚期乳腺癌有较好的临床效果，能提高患者免疫功能，改善患者生存质量及预后。

Objective To investigate the effect of Elemene Injection combined with TAC chemotherapy regimen (docetaxel, cyclophosphamide combined with pirarubicin) in treatment of advanced breast cancer. Methods Patients (105 cases) with advanced breast cancer in Tianjin Medical University Cancer Institute & Hospital from January 2015 to December 2017 were randomly divided into the control group (49 cases) and the treatment group (56 cases). Patients in the control group were given TAC chemotherapy regimen:patients were iv administered with Docetaxel Injection, 75 mg/m², and patients were iv administered with Cyclophosphamide for injection, 500 mg/m² added into normal saline 20-30 mL, and patients were also iv administered with Pirarubicin Hydrochloride for injection, 60 mg/m² added into 5% glucose solution 10 mL. Patients in the treatment group were iv administered with Elemene Injection on the basis of the control group, 0.4-0.6 g/time, once daily. Each chemotherapy cycle had 21 d, and patients in two groups were treated for 6 cycles. After treatment, the clinical efficacies were evaluated, and immune function, toxic reaction, quality of life, and prognosis in two groups were compared. Results After treatment, the total effective rate of the treatment group (44.64%) was significantly higher than that of the control group (26.53%) (P<0.05). After treatment, the scores of physical function (PF), cognitive function (CF), and total health status (QL) in two groups were higher than those before treatment (P<0.05). And the scores of PF, CF, and QL in the treatment group were significantly higher than those in the control group after treatment (P<0.05). After treatment, the CD3⁺ and CD4⁺ in the treatment group were higher than before treatment, but the CD8⁺ in the treatment group was lower than before treatment (P<0.05). The CD8⁺ in the control group was lower than before treatment (P<0.05). After treatment, the CD3⁺ and CD4⁺ in the treatment group were significantly lower than those in the control group (P<0.05). After treatment, the levels of immunoglobulin G (IgG) and immunoglobulin M (IgM) in the treatment group were higher than those before treatment (P<0.05), and the levels of IgG and IgM in the treatment group were significantly higher than those in the control group (P<0.05). After treatment, there was no significant difference in toxicity between two groups. The median progression free survival time (14 months) of the treatment group was significantly longer than that of the control group (10 months), and the total survival time (22 months) of the treatment group was significantly longer than that of the control group (17 months), and the difference was statistically significant (P<0.05). Conclusion Elemene Injection combined with TAC chemotherapy regimen has clinical curative effect in treatment of advanced breast cancer, can improve the immune function, quality of life and prognosis of patients.

R979.1

国家自然科学基金资助项目（81703454）