目的 探寻正元胶囊联合紫杉醇（白蛋白结合型）和卡培他滨治疗晚期三阴性乳腺癌的临床疗效。方法 选取2023年2月—2025年2月潍坊市人民医院收治的100例三阴性乳腺癌患者，按照随机数字表法分对照组和治疗组，每组各50例。对照组静脉滴注注射用紫杉醇（白蛋白结合型），每次260 mg/m²，每3周一次；同时口服卡培他滨片，每次1 g/m²，第1～14天每日2次。治疗组在对照组治疗基础上口服正元胶囊，4粒/次，3次/d。21 d为一个周期，两组共治疗3个周期。观察两组的临床疗效，比较两组癌症疲乏量表（CFS）评分、中文版乳腺癌患者生命质量测定量表（FACT-B）评分、临床症状改善、卡诺夫斯基功能状态（KPS）评分、免疫功能（CD3⁺、CD4⁺、CD8⁺及NK细胞）。结果 治疗组客观有效率（ORR）、疾病控制率（DCR）分别是16.00%、90.00%，显著高于对照组的2.00%、62.00%（P＜0.05）。治疗后，治疗组CFS量表中情感疲乏评分、躯体疲乏评分、认知疲乏评分、总评分均较治疗前显著降低（P＜0.05），且治疗组情感疲乏评分、躯体疲乏评分、认知疲乏评分、总评分低于对照组（P＜0.05）。治疗后，两组生理状况评分、情感状况评分、功能状况评分、社会状况评分、附加关注评分、总分均较治疗前显著增加（P＜0.05）；治疗后，治疗组生理状况评分、情感状况评分、功能状况评分、社会状况评分、附加关注评分、总分高于对照组（P＜0.05）。治疗后，两组证候积分显著降低，而KPS评分较前提高（P＜0.05）；治疗后治疗组证候积分低于对照组，KPS评分高于对照组（P＜0.05）。治疗后，两组CD3⁺、CD4⁺及NK细胞较前降低，CD8⁺升高（P＜0.05）；治疗后治疗组CD3⁺、CD4⁺及NK细胞高于对照组，CD8⁺低于对照组（P＜0.05）。结论 正元胶囊联合紫杉醇（白蛋白结合型）和卡培他滨在治疗晚期三阴性乳腺癌的治疗中展现出多重获益，不仅能显著提高患者的临床疗效和生存质量，还有助于缓解临床症状、减轻癌因性疲乏程度，同时未对机体免疫功能产生明显影响。

Objective To explore the effect of Zhengyuan Capsules combined with paclitaxel (albumin bound) and capecitabine in treatment of advanced triple negative breast cancer. Methods From February 2023 to February 2025, 100 patients with triple-negative breast cancer admitted to Weifang People’s Hospital were selected and divided into control group and treatment group according to random number table method, with 50 cases in each group. Patients in control group were given intravenous infusion of Paclitaxel for injection (Albumin Bound), 260 mg/m² each time, once every 3 weeks. At the same time, they were orally administered Capecitabine Tablets, 1 g/m² each time, twice daily from day 1 to day 14. Patients in treatment group were given oral Zhengyuan Capsules, 4 capsules each time, 3 times a day on the basis of control group. 21-Day period was considered as one cycle, and both groups were treated for 3 cycles. The clinical efficacy of two groups was observed, and the cancer fatigue scale (CFS) score, the Chinese version of the breast cancer patient quality of life measurement scale (FACT-B) score, improvement of clinical symptoms, Karnofsky performance status (KPS) score, and immune function (CD3⁺, CD4⁺, CD8⁺, and NK cells) were compared between two groups. Results The objective response rate (ORR) and disease control rate (DCR) in treatment group were 16.00% and 90.00%, respectively, which were significantly higher than those of control group (2.00% and 62.00%) (P < 0.05). After treatment, the scores of emotional fatigue, physical fatigue, cognitive fatigue and total score in the CFS scale of the treatment group were significantly lower than those before treatment (P< 0.05), and the scores of emotional fatigue, physical fatigue, cognitive fatigue and total score in the treatment group were lower than those in the control group (P < 0.05). After treatment, the physiological status score, emotional status score, functional status score, social status score, additional concern score and total score of both groups were significantly increased compared with those before treatment (P < 0.05). After treatment, the physiological status score, emotional status score, functional status score, social status score, additional concern score and total score of the treatment group were higher than those of the control group (P < 0.05). After treatment, the syndrome scores of both groups significantly decreased, while the KPS score was higher than before (P < 0.05). After treatment, the syndrome scores of the treatment group were lower than those of the control group, and the KPS score was higher than that of the control group (P < 0.05). After treatment, the CD3⁺, CD4⁺ and NK cell counts of both groups decreased compared with those before treatment, while CD8⁺ increased (P < 0.05). After treatment, the CD3⁺, CD4⁺ and NK cell counts of the treatment group were higher than those of the control group, and CD8⁺ was lower than that of the control group (P < 0.05). Conclusion Zhengyuan Capsules combined with paclitaxel (albumin-bound) and capecitabine have demonstrated multiple benefits in treatment of advanced triple-negative breast cancer, not only significantly improves the clinical efficacy and life quality of patients, but also helps alleviate clinical symptoms and reduce the degree of cancer-related fatigue. At the same time, it does not have a significant impact on the body’s immune function.

R979.1

吴阶平医学基金会支持项目（NO.320.6750.2023-18-40）