目的 探讨槐耳颗粒联合AP方案（培美曲塞和顺铂）治疗乳腺癌的临床疗效。方法 选取2017年6月-2018年12月在天津市职业病防治院治疗的100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50例。对照组患者给予AP化疗方案，即第1天静脉滴注注射用培美曲塞二钠，500 mg/m²，第1~3天静脉滴注注射用顺铂75 mg/m²；治疗组患者在对照组的基础上口服槐耳颗粒，1袋/次，3次/d。2周为1个疗程，两组治疗3个疗程。观察两组的临床疗效，比较两组的生存质量测定量表简表（QOL-BREF）评分、血清肿瘤标志物水平。结果 治疗后，对照组和治疗组客观缓解率（ORR）分别为52.00%、58.00%；治疗组疾病控制率（CBR）分别为74.00%、78.00%；两组患者ORR和CBR比较无显著差异。治疗后，两组患者QOL-BREF评分显著升高，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组患者QOL-BREF评分明显高于对照组，两组比较差异有统计学意义（P<0.05）。治疗后，两组患者CEA、CA125、CA153和VEGF水平均显著降低，同组治疗前后比较差异有统计学意义（P<0.05）；且治疗组患者血清肿瘤标志物水平明显低于对照组，两组比较差异有统计学意义（P<0.05）。治疗后，对照组和治疗组恶心、呕吐发生率分别为20.00%、10.00%，白细胞减少发生率分别为22.00%、12.00%，中性粒细胞减少发生率分别为18.00%、8.00%，转氨酶升高发生率分别为24.00%、10.00%，两组不良反应发生率比较差异有统计学意义（P<0.05）。结论 槐耳颗粒联合AP方案治疗乳腺癌具有较好的临床疗效，能降低肿瘤标志物水平，提高生活质量，安全性较高，具有一定的临床推广应用价值。

Objective To investigate the clinical effect of Huaier Granules combined with AP scheme in treatment of breast cancer. Methods Patients (100 cases) with breast cancer in Tianjin Occupational Diseases Precaution and Therapeutic Hospital from June 2017 to December 2018 were randomly divided into control and treatment groups, and each group had 50 cases. Patients in the control group were given AP scheme, and at the first day, patients in the control group were iv administered with Pemetrexed Disodium for injection, 500 mg/m². At the first to third day, patients in the control group were iv administered with Cisplatin for injection, 75 mg/m². Patients in the treatment group were po administered with Huaier Granules on the basis of the control group, 1 bag/time, three times daily. A course had 2 weeks, and patients in two groups were treated for 3 courses. After treatment, the clinical efficacies were evaluated, and QOL-BREF scores and the levels of tumor markers in two groups were compared. Results After treatment, ORR in the control and treatment groups were 52.00% and 58.00%, respectively, and CBR in the control and treatment groups were 74.00% and 78.00%, respectively, and there was no difference between two groups. After treatment, QOL-BREF scores in two groups were significantly increased, and the difference was statistically significant in the same group (P<0.05). And the QOL-BREF scores in the treatment group were significantly higherer than those in the control group, with significant difference between two groups (P<0.05). After treatment, the levels of CEA, CA125, CA153, and VEGF in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the tumor markers in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, the incidence of nausea and vomiting in the control and treatment groups were 20.00% and 10.00%, respectively, the incidence of leukopenia in the control and treatment groups were 22.00% and 12.00%, respectively, the incidence of neutropenia in the control and treatment groups were 18.00% and 8.00%, respectively, the incidence of transaminase rise in the control and treatment groups were 24.00% and 10.00%, respectively, and there was difference between two groups (P<0.05). Conclusion Huaier Granules combined with AP scheme has clinical curative effect in treatment of breast cancer, can reduce the level of tumor markers, and improve the quality of life, with good safety, which has a certain clinical application value.

R979.1

天津市卫生局科技基金资助项目（2014KZ055）