目的 探討康力欣膠囊聯(lián)合TX方案治療晚期三陰性乳腺癌的臨床療效。方法 選取2020年1月—2024年1月海南醫(yī)學(xué)院第一附屬醫(yī)院收治的116例晚期三陰性乳腺癌患者，按隨機(jī)數(shù)字表法將患者分為對照組和治療組，每組各58例。對照組接受TX方案治療，第1天靜脈滴注多西他賽注射液，75 mg/m²；第1～14天餐后30 min溫水吞服卡培他濱片，1 250 mg/m²，2次/d。治療組在對照組治療基礎(chǔ)上餐后30 min溫水口服康力欣膠囊，3粒/次，3次/d。兩組均以21 d為1個(gè)周期，連續(xù)治療4個(gè)周期。觀察兩組的臨床療效，比較兩組治療前后病灶最大徑、簡式抑郁–焦慮–壓力量表（DASS-21）評分、癌癥治療性功能評價(jià)量表–乳腺癌（FACT-B）評分及血清腫瘤標(biāo)志物、白細(xì)胞介素-6（IL-6）、CC趨化因子配體20（CCL20）和外周血T淋巴細(xì)胞亞群水平變化。統(tǒng)計(jì)兩組藥物不良反應(yīng)情況。結(jié)果 治療后，治療組客觀緩解率（ORR）、疾病控制率（DCR）分別是50.00%、86.21%，顯著高于對照組的31.03%、70.69%（P＜0.05）。治療后，兩組病灶最大徑顯著減小，DASS-21評分均明顯降低（P＜0.05）；治療后，治療組病灶最大徑和DASS-21評分改善均顯著優(yōu)于對照組（P＜0.05）。治療后，兩組FACT-B各維度評分和總評分均較治療前顯著升高（P＜0.05）；治療后，治療組FACT-B評分高于對照組（P＜0.05）。治療后，兩組血清癌胚抗原（CEA）、糖類抗原15-3（CA15-3）、IL-6、CCL20水平均顯著降低，治療組CD4⁺和CD4⁺/CD8⁺顯著升高（P＜0.05）；治療后，治療組血清腫瘤標(biāo)志物、IL-6、CCL20和外周血T淋巴細(xì)胞亞群水平改善優(yōu)于對照組。治療過程中，治療組血小板降低、白細(xì)胞降低、胃腸道反應(yīng)發(fā)生率分別是10.34%、13.79%、15.52%，均顯著低于對照組的（24.14%、31.03%、34.48%）（P＜0.05）。結(jié)論 康力欣膠囊聯(lián)合TX方案能提高晚期三陰性乳腺癌患者的近期療效，可有效減輕腫瘤負(fù)荷，改善腫瘤微環(huán)境，提高機(jī)體抗腫瘤免疫效應(yīng)，改善患者不良情緒和生活質(zhì)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

海南省衛(wèi)生計(jì)生行業(yè)科研項(xiàng)目(22A200068)