目的 探讨康力欣胶囊联合TX方案治疗晚期三阴性乳腺癌的临床疗效。方法 选取2020年1月—2024年1月海南医学院第一附属医院收治的116例晚期三阴性乳腺癌患者，按随机数字表法将患者分为对照组和治疗组，每组各58例。对照组接受TX方案治疗，第1天静脉滴注多西他赛注射液，75 mg/m²；第1～14天餐后30 min温水吞服卡培他滨片，1 250 mg/m²，2次/d。治疗组在对照组治疗基础上餐后30 min温水口服康力欣胶囊，3粒/次，3次/d。两组均以21 d为1个周期，连续治疗4个周期。观察两组的临床疗效，比较两组治疗前后病灶最大径、简式抑郁–焦虑–压力量表（DASS-21）评分、癌症治疗性功能评价量表–乳腺癌（FACT-B）评分及血清肿瘤标志物、白细胞介素-6（IL-6）、CC趋化因子配体20（CCL20）和外周血T淋巴细胞亚群水平变化。统计两组药物不良反应情况。结果 治疗后，治疗组客观缓解率（ORR）、疾病控制率（DCR）分别是50.00%、86.21%，显著高于对照组的31.03%、70.69%（P＜0.05）。治疗后，两组病灶最大径显著减小，DASS-21评分均明显降低（P＜0.05）；治疗后，治疗组病灶最大径和DASS-21评分改善均显著优于对照组（P＜0.05）。治疗后，两组FACT-B各维度评分和总评分均较治疗前显著升高（P＜0.05）；治疗后，治疗组FACT-B评分高于对照组（P＜0.05）。治疗后，两组血清癌胚抗原（CEA）、糖类抗原15-3（CA15-3）、IL-6、CCL20水平均显著降低，治疗组CD4⁺和CD4⁺/CD8⁺显著升高（P＜0.05）；治疗后，治疗组血清肿瘤标志物、IL-6、CCL20和外周血T淋巴细胞亚群水平改善优于对照组。治疗过程中，治疗组血小板降低、白细胞降低、胃肠道反应发生率分别是10.34%、13.79%、15.52%，均显著低于对照组的（24.14%、31.03%、34.48%）（P＜0.05）。结论 康力欣胶囊联合TX方案能提高晚期三阴性乳腺癌患者的近期疗效，可有效减轻肿瘤负荷，改善肿瘤微环境，提高机体抗肿瘤免疫效应，改善患者不良情绪和生活质量。

Objective To investigate the clinical efficacy of Kanglixin Capsules combined with TX regimen in treatment of advanced triple-negative breast cancer. Methods A total of 116 patients with advanced triple-negative breast cancer admitted to the First Affiliated Hospital of Hainan Medical College from January 2020 to January 2024 were selected and divided into control group and treatment group according to random number table method, with 58 cases in each group. Patients in the control group were given TX regimen, and Docetaxel Injection 75 mg/m² were injected intraventically on the first day. And they swallowed Capecitabine Tablets with warm water 30 min after meals, from day 1 to 14, twice daily. Patients in treatment group were po administered with Kanglixin Capsule with warm water 30 min after meal on the basis of control group, 3 capsules/time, 3 times daily. 21 d was as 1 course, both groups were treated for 4 consecutive cycles. The clinical efficacy of the two groups was observed, and the changes of lesion size, DASS-21 score, FACT-B score, serum tumor markers, interleukin-6 (IL-6), CC chemokine ligand 20 (CCL20) and peripheral blood T lymphocyte subsets before and after treatment were compared between two groups. The adverse reaction of drugs in two groups were analyzed. Results After treatment, ORR and DCR in treatment group were 50.00% and 86.21%, respectively, which were significantly higher than 31.03% and 70.69% in the control group (P < 0.05). After treatment, the maximum lesion diameter and DASS-21 score were significantly decreased in both groups (P < 0.05). After treatment, the improvement of lesion maximum diameter and DASS-21 score in treatment group was significantly better than that in control group (P < 0.05). After treatment, FACT-B scores and total scores in both groups were significantly higher than before treatment (P < 0.05). After treatment, the FACT-B score of treatment group was higher than that of control group (P < 0.05). After treatment, the serum levels of carcinoembryonic antigen (CEA), carbohydrate antigen 15-3 (CA15-3), IL-6 and CCL20 were significantly decreased in both groups, and CD4⁺ and CD4⁺/CD8⁺ were significantly increased in treatment group (P < 0.05). After treatment, the levels of serum tumor markers, IL-6, CCL20 and peripheral blood T lymphocyte subsets in treatment group were better than those in control group. During the treatment, the incidence of thrombocytopenia, leukopenia, and gastrointestinal reaction in treatment group were 10.34%, 13.79% and 15.52%, respectively, which were significantly lower than those in control group (24.14%, 31.03% ,and 34.48%) (P < 0.05). Conclusion Kanglixin Capsules combined with TX regimen can improve the short-term efficacy of advanced triple-negative breast cancer patients, effectively reduce tumor load, improve tumor microenvironment and anti-tumor immune effect, which can improve patients’ bad mood and quality of life.

R979.1

海南省卫生计生行业科研项目(22A200068)