目的 探讨参丹散结胶囊联合吉西他滨和顺铂（GP）化疗方案治疗晚期非小细胞肺癌的临床疗效。方法 选取2023年2月—2025年4月西安交通大学第一附属医院榆林医院接诊的晚期非小细胞肺癌患者108例作为研究对象，依据随机数表法进行分为对照组与治疗组，每组各54例。对照组患者给予GP化疗方案治疗，静脉滴注注射用盐酸吉西他滨，剂量为1 000 mg/m²，滴注时间30 min，在21 d的治疗周期内，第1、8天给药，同时静脉滴注注射用顺铂，剂量为75 mg/m²，在治疗周期内的第1、2天给药，连续化疗4个周期。治疗组在GP化疗方案基础上口服参丹散结胶囊，6粒/次，3次/d，治疗时间同步化疗时间。观察两组患者的客观缓解率（ORR）和疾病控制率（DCR），比较两组治疗前后生活质量、血清肿瘤标志物癌胚抗原（CEA）、鳞状细胞癌相关抗原（SCCA）、神经元特异烯醇化酶（NSE）、细胞角蛋白19片段（CYFRA21-1）、免疫功能指标T淋巴细胞亚型CD3⁺、CD4⁺、CD8⁺、CD4⁺/CD8⁺和自然杀伤细胞（NK）和不良反应。结果 相较于对照组，治疗组ORR与DCR更高（P＜0.05）。治疗后，两组患者CEA、SCCA、NSE及CYFRA21-1水平均明显下降（P＜0.05），同时治疗后治疗组各项血清肿瘤标志物水平均显著低于对照组（P＜0.05）。治疗后，两组外周血CD3⁺、CD4⁺ T淋巴细胞水平、CD4⁺/CD8⁺值及NK细胞数量较治疗前均显著降低，而CD8⁺ T淋巴细胞水平显著上升（P＜0.05）；治疗后，治疗组CD3⁺、CD4⁺ T淋巴细胞水平、CD4⁺/CD8⁺值及NK细胞数量高于对照组，CD8⁺ T淋巴细胞低于对照组（P＜0.05）。两组患者治疗后肺癌治疗功能评估量表各项评分和总分均明显高于治疗前，同时治疗组患者治疗后生活质量评分均显著高于对照组（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 参丹散结胶囊联合GP化疗方案治疗晚期非小细胞肺癌的临床疗效有所提升，能够改善生活质量和免疫功能，并且下调血清肿瘤标志物水平，不良反应减少。

Objective This study aimed to evaluate the clinical efficacy of Shendan Sanjie Capsules combined with the gemcitabine plus cisplatin (GP) chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC). Methods A total of 108 patients diagnosed with advanced NSCLC who were treated at Yulin Hospital, the First Affiliated Hospital of Xi’an Jiaotong University, from February 2023 to April 2025 were enrolled and randomly assigned to a control group and a treatment group, with 54 patients in each group. The control group received standard GP chemotherapy. Specifically, gemcitabine hydrochloride (1000 mg/m²) was intravenously infused over 30 minutes on days 1 and 8 of a 21-day cycle, and cisplatin (75 mg/m²) was administered via intravenous infusion on days 1 and 2 of each cycle, with four consecutive cycles of chemotherapy completed. On the basis of the identical GP chemotherapy regimen, the treatment group received additional oral administration of Shendan Sanjie Capsules (6 capsules per time, three times daily) throughout the chemotherapy period. The primary outcomes included objective response rate (ORR) and disease control rate (DCR). Secondary outcomes encompassed quality of life, serum levels of tumor markers including carcinoembryonic antigen (CEA), squamous cell carcinoma antigen (SCCA), neuron-specific enolase (NSE), and cytokeratin 19 fragment (CYFRA21-1), peripheral immune parameters CD3⁺, CD4⁺, CD8⁺, CD4⁺/CD8⁺ ratio, and natural killer (NK) cells, as well as the incidence of adverse reactions before and after treatment. Results The treatment group exhibited significantly higher ORR and DCR than the control group (P< 0.05). After treatment, the levels of CEA, SCCA, NSE, and CYFRA21-1 in both groups significantly decreased (P < 0.05), and the levels of all serum tumor markers in treatment group after treatment were significantly lower than those in control group (P < 0.05). After treatment, the levels of peripheral blood CD3⁺, CD4⁺ T lymphocytes, CD4⁺/CD8⁺, and NK cell numbers in both groups were significantly lower than those before treatment, while the level of CD8⁺ T lymphocytes significantly increased (P< 0.05), after treatment, the levels of CD3⁺, CD4⁺ T lymphocytes, CD4⁺/CD8⁺, and NK cell numbers in treatment group were higher than those in control group, while the level of CD8⁺ T lymphocytes was lower than that in control group (P< 0.05). Additionally, all subscale scores and total scores of the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale were significantly elevated in both groups post-treatment, with the treatment group demonstrating superior quality of life improvements relative to the control group (P < 0.05). Furthermore, the incidence of adverse reactions was notably lower in the treatment group (P < 0.05). Conclusion The combination of Shendan Sanjie Capsules and GP chemotherapy exerts superior clinical efficacy in the treatment of advanced NSCLC. This combinatorial strategy can effectively downregulate serum tumor markers, improve patients’ immune function and quality of life, and reduce chemotherapy-related adverse effects, serving as a safe and effective therapeutic regimen for advanced NSCLC.

R979.1

陕西省重点研发计划项目（2023-YBSF-737）