目的 探讨康力欣胶囊联合白蛋白紫杉醇治疗Her-2阴性晚期乳腺癌的临床疗效。方法 选取2020年2月—2022年1月广安门医院南区收治的96例Her-2阴性晚期乳腺癌患者，随机分为对照组（48例）和治疗组（48例）。对照组静脉滴注注射用紫杉醇（白蛋白结合型），260 mg/m²，1次/3周为1个周期，共3个周期。治疗组在对照组治疗基础上口服康立欣胶囊，1.5 g/次，3次/d，治疗3个周期。观察两组患者临床疗效，比较治疗前后两组患者视觉模拟评分（VAS），血清癌胚抗原（CEA）和糖类抗原153（CA153）水平，及无进展生存期和不良反应情况。结果 治疗后，治疗组患者客观缓解率（ORR）和疾病控制率（DCR）分别为62.50%和89.58%，均明显高于对照组41.67%和72.92%，两组比较差异均具有统计学意义（P＜0.05）。治疗后，两组VAS评分及血清CEA和CA153均明显降低（P＜0.05），且治疗组治疗后VAS评分及血清CEA和CA153水平均低于对照组（P＜0.05）。治疗组患者中位无进展生存期为5.23个月（95% CI：4.37～6.09），长于对照组2.85个月（95% CI：2.29～3.42），两组比较差异具有统计学意义（P＜0.05）。治疗组患者不良反应发生率明显低于对照组（33.33% vs 97.92%，P＜0.05）。结论 康力欣胶囊联合白蛋白紫杉醇治疗Her-2阴性晚期乳腺癌患者具有良好的治疗疗效及较低的不良反应发生率。

Objective To explore the efficacy of Kanglixin Capsules combined with paclitaxel (albumin bound) in treatment of Her-2 negative advanced breast cancer. Methods Patients (96 cases) with Her-2 negative advanced breast cancer in South District of Guang'anmen Hospital from February 2020 to January 2022 were randomly divided into control (48 cases) and treatment (48 cases) group. Patients in the control group were iv administered with Paclitaxel for Injection (Albumin Bound), 260 mg/m², once every 3 weeks as a course of treatment, and they were treated for 3 courses of treatment. Patients in the treatment group were po administered with Kanglixin Capsules on the basis of the control group, 1.5 g/time, three times daily, they were treated for 3 courses of treatment. After treatment, the clinical evaluation was evaluated, and the VAS scores and tumor marker CEA and CA153 levels, progression free survival and adverse reactions in two groups before and after treatment were compared. Results After treatment, the objective remission rate (ORR) and disease control rate (DCR) in the treatment group were 62.50% and 89.58% respectively, which were significantly higher than those in the control group (41.67% and 72.92%), there was significant difference between two groups (P < 0.05). After treatment, the VAS score and serum CEA, CA153 in two groups were significantly decreased (P < 0.05), and which in the treatment group were lower than those in the control group (P < 0.05). The median progression-free survival time in the treatment group was 5.23 months (95% CI: 4.37 — 6.09), which was significantly longer than that in the control group (2.85 months 95% CI: 2.29 — 3.42), and there was significant difference between two groups (P< 0.05). The incidence of adverse reactions in the treatment group was significantly lower than that in the control group (33.33% vs 97.92%, P <0.05). Conclusion Kanglixin Capsules combined with albumin paclitaxel has good therapeutic effect and low incidence of adverse reactions in Her-2 negative advanced breast cancer patients.

R979.1

北京市中医药科研课题(JJ2019-74)