目的 探讨安康欣胶囊联合紫杉醇＋卡铂（TC）方案治疗晚期非小细胞肺癌的临床效果。方法 选择2023年2月—2025年5月于中国人民解放军北部战区总医院化疗的晚期非小细胞肺癌患者100例，按照简单随机法分为对照组（50例）和治疗组（50例）。对照组患者行TC化疗方案，以“第1天紫杉醇注射液＋第2天卡铂注射液”为1个治疗周期，每21天重复1次，连续完成3个周期。治疗组对照组基础上口服安康欣胶囊，3次/d，4～6粒/次，治疗时间与化疗时间同步。统计两组患者的客观缓解率和疾病控制率，比较两组患者治疗前后的卡氏评分（KPS）、血清肿瘤标志物癌胚抗原（CEA）、鳞状细胞癌抗原（SCCA）和细胞角蛋白19片段抗原（CYFRA21‑1），免疫功能指标白细胞分化抗原CD3⁺、CD4⁺、CD8⁺和CD4⁺/CD8⁺，及不良反应情况。结果 治疗组的客观缓解率和疾病控制率均明显高于对照组（64.00% vs 38.00%，88.00% vs 66.00%，P＜0.05）。两组患者治疗后KPS评分明显高于治疗前（P＜0.05），同时治疗组KPS评分显著高于对照组（P＜0.05）。治疗后，两组病患的血清CEA、SCCA和CYFRA21‑1水平较治疗前显著下降（P＜0.05），且治疗组的肺癌相关肿瘤标志物水平均显著低于对照组（P＜0.05）。治疗结束时，治疗组外周血中CD3⁺、CD4⁺细胞比例及CD4⁺/CD8⁺值较治疗前有显著降低，而CD8⁺细胞比例则显著升高（P＜0.05），且与对照组相比，治疗后治疗组免疫功能指标显著更好（P＜0.05）。治疗组不良反应发生率明显低于对照组（P＜0.05）。结论 安康欣胶囊联合TC化疗方案能够有效治疗晚期非小细胞肺癌，不仅可以提高生活质量和免疫功能，而且能够降低肿瘤标志物水平，安全性高。

Objective To investigate the clinical efficacy of Ankangxin Capsules combined with paclitaxel plus carboplatin (TC) regimen in the treatment of advanced non‑small cell lung cancer (NSCLC). Methods A total of 100 patients with advanced NSCLC who received chemotherapy at General Hospital of Northern Theater Command of PLA from February 2023 to May 2025 were divided into control group (50 cases) and treatment group (50 cases) by simple random method. The control group was treated with the TC chemotherapy regimen: Paclitaxel Injection on day 1 plus Carboplatin Injection on day 2 for one cycle, repeated every 21 days for 3 consecutive cycles. On the basis of the control group, the treatment group was additionally given oral Ankangxin Capsules, 4 — 6 capsules each time, 3 times a day, with the treatment duration synchronized with chemotherapy. The objective response rate (ORR) and disease control rate (DCR) were calculated. The Karnofsky Performance Status (KPS) score, serum tumor markers including carcinoembryonic antigen (CEA), squamous cell carcinoma antigen (SCCA), cytokeratin 19 fragment antigen (CYFRA21‑1), immune function indexes including CD3⁺, CD4⁺, CD8⁺ and CD4⁺/CD8⁺ ratio, and adverse reactions were compared between two groups before and after treatment. Results The ORR and DCR in the treatment group were significantly higher than those in the control group (64.00% vs 38.00%, 88.00% vs 66.00%, both P < 0.05). After treatment, the KPS scores in two groups were significantly higher than those before treatment (P < 0.05), and the KPS score in the treatment group was markedly higher than that in the control group (P < 0.05). After treatment, the serum levels of CEA, SCCA and CYFRA21‑1 in both groups were significantly lower than those before treatment (P < 0.05), and the levels of lung cancer‑related tumor markers in the treatment group were notably lower than those in the control group (P < 0.05). At the end of treatment, the percentages of CD3⁺ and CD4⁺ cells and the CD4⁺/CD8⁺ ratio in peripheral blood in the treatment group were significantly increased, while the percentage of CD8⁺ cells was significantly decreased (P < 0.05); compared with the control group, the immune function indexes in the treatment group were significantly better (P < 0.05). The incidence of adverse reactions in the treatment group was significantly lower than that in the control group (P < 0.05). Conclusion Ankangxin Capsules combined with TC chemotherapy regimen is effective in the treatment of advanced NSCLC, which can not only improve quality of life and immune function, but also reduce the levels of tumor markers, with high safety.

R979.1

辽宁省重点研发计划指导计划项目（2022045029）