目的 探索清肺散结丸联合TP方案治疗晚期非小细胞肺癌的临床疗效。方法 选择2024年3月—2025年5月西安交通大学第一附属医院榆林医院收治的116例晚期非小细胞肺癌患者，根据随机信封法将患者分为对照组和治疗组，每组58例。对照组患者采用TP方案治疗，第1天静脉滴注紫杉醇注射液175 mg/m²，输注3 h。第2天静脉滴注顺铂注射液75 mg/m²，静脉滴注2～6 h。治疗组患者在对照组基础上口服清肺散结丸，3 g/次，2次/d。以21 d为1个周期，两组连续治疗4个周期。比较两组患者的临床疗效及治疗前后的卡氏评分（KPS）、血清肿瘤标志物[癌胚抗原（CEA）、神经元特异性烯醇化酶（NSE）和细胞角蛋白19片段抗原21-1（CYFRA21-1）]、免疫功能指标[白细胞分化抗原（CD）3⁺、CD4⁺、CD8⁺、CD4⁺/CD8⁺、免疫球蛋白A（IgA）和IgG]和不良反应发生率。结果 治疗组患者客观缓解率和疾病控制率分别为63.79%、87.93%，明显高于对照组的39.66%、67.24%（P＜0.05）。与治疗前相比，两组患者治疗后KPS评分明显升高（P＜0.05），且治疗组KPS评分显著高于对照组（P＜0.05）。与治疗前相比，两组患者治疗后血清CEA、NSE和CYFRA21-1水平均明显降低（P＜0.05），且治疗组患者血清CEA、NSE和CYFRA21-1水平均显著低于对照组（P＜0.05）。与治疗前相比，两组CD3⁺、CD4⁺、CD4⁺/CD8⁺、IgA和IgG水平均明显下降，而CD8⁺水平显著升高（P＜0.05），且治疗组治疗后CD3⁺、CD4⁺、CD4⁺/CD8⁺、IgA和IgG水平高于对照组，CD8⁺水平低于对照组（P＜0.05）。治疗组不良反应发生率（22.41%）明显低于对照组的44.83%（P＜0.05）。结论 清肺散结丸联合TP方案治疗晚期非小细胞肺癌患者的疗效确切，能够有效提高生活质量，改善血清肿瘤标志物和免疫功能，减少临床不良反应。

Objective To explore the clinical efficacy of Qingfei Sanjie Pills combined with TP regimen in treatment of advanced non-small cell lung cancer. Methods A total of 116 patients with advanced non-small cell lung cancer admitted to Yulin Hospital, the First Affiliated Hospital of Xi'an Jiaotong University from March 2024 to May 2025 were enrolled. The patients were divided into control group and treatment group using the random envelope method, with 58 cases in each group. The control group was treated with TP regimen: Paclitaxel Injection 175 mg/m² was intravenously infused for 3 h on the first day, and cisplatin injection 75 mg/m² was intravenously infused for 2 — 6 h on the second day. On the basis of the control group, the treatment group additionally was po administered with Qingfei Sanjie Pills, 3 g/time, twice daily. One treatment cycle lasted 21 days, and both groups received continuous treatment for 4 cycles. The clinical efficacy, KPS score, serum tumor markers [carcinoembryonic antigen (CEA), neuron-specific enolase (NSE) and cytokeratin 19 fragment antigen 21-1 (CYFRA21-1)], immune function indicators [cluster of differentiation (CD) 3⁺, CD4⁺, CD8⁺, CD4⁺/CD8⁺ ratio, immunoglobulin A (IgA) and IgG], and incidence of adverse reactions were compared between the two groups before and after treatment. Results The objective response rate and disease control rate were 63.79% and 87.93% in the treatment group, which were significantly higher than 39.66% and 67.24% in the control group (P < 0.05). Compared with pre-treatment levels, the KPS scores of both groups increased significantly after treatment (P < 0.05), and the KPS score of the treatment group was significantly higher than that of the control group (P < 0.05). Compared with pre-treatment levels, serum CEA, NSE, and CYFRA21-1 levels in both groups significantly decreased after treatment (P < 0.05). Furthermore, the improvement in serum tumor marker levels in the treatment group was significantly greater than that in the control group (P < 0.05). Compared with before treatment, the levels of CD3⁺, CD4⁺, CD4⁺/CD8⁺, IgA and IgG in both groups significantly decreased, but the level of CD8⁺ significantly increased (P < 0.05). The levels of CD3⁺, CD4⁺, CD4⁺/CD8⁺, IgA and IgG in treatment group after treatment were higher than those in control group, but the level of CD8⁺ was lower than that in control group (P < 0.05). The incidence of adverse reactions was 22.41% in the treatment group, significantly lower than 44.83% in the control group (P < 0.05). Conclusion Qingfei Sanjie Pills combined with TP regimen are effective in treatment of advanced non-small cell lung cancer patients, can effectively improve quality of life, serum tumor markers and immune function, and reducing clinical adverse reactions.

陕西省重点研发计划项目（2023-YBSF-737）