目的 评价注射用香菇多糖联合AC方案和紫杉醇治疗晚期三阴性乳腺癌的临床疗效和安全性。方法 选取2015年1月1日-2017年12月1日天津中医药大学第一附属医院和天津医科大学附属肿瘤医院收治的60例乳腺癌患者为研究对象，将所有患者随机分为对照组和治疗组，每组各30例。对照组患者采用单纯密集AC方案联合紫杉醇：第1天静脉滴注注射用盐酸多柔比星，60 mg/m²，同时第1天也静脉推注注射用环磷酰胺，600 mg/m²，14 d为1个周期，治疗4个周期；之后序贯第1天静脉滴注注射用紫杉醇（白蛋白结合型），175 mg/m²，14 d为1个周期，治疗4个周期。治疗组在对照组治疗的基础上静脉注射注射用香菇多糖，1 mg用2 mL注射用水振摇溶解，加入到生理盐水250 mL中，2次/周，14 d为1个周期，治疗4个周期后进行观察。观察两组的近期临床疗效，比较两组的生活质量评分、淋巴细胞亚群水平、不良反应情况。结果 治疗后，对照组和治疗组的客观有效率（ORR）分别为56.7%、63.3%，疾病控制率（DCR）分别为86.7%、90.0%，两组比较差异无有统计学意义。治疗后，两组患者KPS评分升高，同组治疗前后比较差异无统计学意义，且两组治疗后比较差异亦无统计学意义。治疗后，对照组患者CD4⁺/CD8⁺水平显著降低，治疗组患者CD4⁺、CD4⁺/CD8⁺水平均显著升高，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CD4⁺、CD4⁺/CD8⁺水平明显高于对照组，两组治疗后比较差异具有统计学意义（P<0.05）。治疗后，治疗组白细胞降低、恶心呕吐的Ⅲ~Ⅳ发生率均明显低于对照组，两组不良反应发生率比较差异有统计学意义（P<0.05）。结论 注射用香菇多糖联合AC方案和紫杉醇治疗晚期三阴性乳腺癌具有较好的临床疗效，能改善患者淋巴细胞亚群水平，降低不良反应，具有一定的临床推广应用价值。

Objective To evaluate the efficacy and safety of Lentinan for injection combined with AC regimen and paclitaxel in treatment of advanced triple negative breast cancer. Methods Patients (60 cases) with advanced triple negative breast cancer in the First Teaching Hospital of Tianjin University of TCM and Tianjin Medical University Cancer Institute & Hospital from January 1st 2015 to December 1st 2017 were randomly divided into control and treatment groups, and each group had 30 cases. Patients in the control group were given AC regimen:the first day, patients were iv administered with Doxorubicin Hydrochloride for injection, 60 mg/m², and the first day, patients were also iv administered with Cyclophosphamide for injection, 600 mg/m², 14 d for 1 cycle, treated for 4 cycles. After this, sequential therapy, the first day, patients were iv administered with Paclitaxel for injection (Albumin Bound), 175 mg/m², 14 d for 1 cycle, treated for 4 cycles. Patients in the treatment group were iv administered with Lentinan for injection on the basis of the control group, 1 mg was dissolved by shaking with 2 mL water for injection and added into 250 mL normal saline, twice weekly, 14 d for 1 cycle, and treated for 4 cycles. After treatment, the short-term clinical efficacies were evaluated, and quality of life score, the levels of lymphocyte subsets, and adverse reactions in two groups were compared. Results After treatment, the ORR in the control and treatment groups were 56.7% and 63.3%, respectively, and the DCR in the control and treatment groups were 86.7% and 90.0%, respectively, and there was no difference between two groups. After treatment, KPS scores in two groups were decreased, and the difference was no statistically significant in the same group, and there no significant difference between two groups. After treatment, CD4⁺/CD8⁺ in the control group were significantly decreased, CD4⁺, CD4⁺/CD8⁺ in the treatment group were significantly increased (P<0.05). And the levels of lymphocyte subsets in the treatment group were significantly higher than those in the control group (P<0.05). After treatment, the incidence of Ⅲ-Ⅳ of leucopenia, nausea and vomiting in the treatment group were significantly lower than those in the control group, and there was difference between two groups (P<0.05). Conclusion Lentinan for injection combined with AC regimen and paclitaxel has clinical curative effect in treatment of advanced triple negative breast cancer, can improve the level of lymphocyte subsets, and reduce adverse reactions, which has a certain clinical application value.

R979.1

国家自然科学基金资助项目（81503392）；天津市科技计划项目（15ZXLCSY00020）；天津市卫生和计划生育委员会基金资助项目（2017119）