目的 探討康力欣膠囊聯(lián)合白蛋白紫杉醇治療Her-2陰性晚期乳腺癌的臨床療效。方法 選取2020年2月—2022年1月廣安門醫(yī)院南區(qū)收治的96例Her-2陰性晚期乳腺癌患者，隨機分為對照組（48例）和治療組（48例）。對照組靜脈滴注注射用紫杉醇（白蛋白結(jié)合型），260 mg/m²，1次/3周為1個周期，共3個周期。治療組在對照組治療基礎(chǔ)上口服康立欣膠囊，1.5 g/次，3次/d，治療3個周期。觀察兩組患者臨床療效，比較治療前后兩組患者視覺模擬評分（VAS），血清癌胚抗原（CEA）和糖類抗原153（CA153）水平，及無進展生存期和不良反應(yīng)情況。結(jié)果 治療后，治療組患者客觀緩解率（ORR）和疾病控制率（DCR）分別為62.50%和89.58%，均明顯高于對照組41.67%和72.92%，兩組比較差異均具有統(tǒng)計學(xué)意義（P＜0.05）。治療后，兩組VAS評分及血清CEA和CA153均明顯降低（P＜0.05），且治療組治療后VAS評分及血清CEA和CA153水平均低于對照組（P＜0.05）。治療組患者中位無進展生存期為5.23個月（95% CI：4.37～6.09），長于對照組2.85個月（95% CI：2.29～3.42），兩組比較差異具有統(tǒng)計學(xué)意義（P＜0.05）。治療組患者不良反應(yīng)發(fā)生率明顯低于對照組（33.33% vs 97.92%，P＜0.05）。結(jié)論 康力欣膠囊聯(lián)合白蛋白紫杉醇治療Her-2陰性晚期乳腺癌患者具有良好的治療療效及較低的不良反應(yīng)發(fā)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

北京市中醫(yī)藥科研課題(JJ2019-74)