目的 探讨华蟾素注射液联合PP方案治疗晚期肺腺癌的临床疗效。方法 纳入2023年2月—2025年8月南方医科大学中西医结合医院收治的122例晚期肺腺癌患者，按照随机数字表法分为对照组和治疗组，每组各61例。对照组采用PP方案治疗，第1天静脉滴注注射用培美曲塞二钠500 mg/m²，静脉滴注顺铂注射液75 mg/m²。在对照组基础上，治疗组静脉滴注华蟾素注射液，20 mL/次加入5%葡萄糖注射液500 mL，1次/d。21 d为1个周期，两组连续治疗4个周期。观察两组临床疗效，比较治疗前后肿瘤标志物癌胚抗原（CEA）、细胞角蛋白19片段抗原21-1（CYFRA21-1）、鳞状细胞癌抗原（SCC-Ag）、欧洲癌症研究与治疗组织生活质量肺癌特异性量表（EORTC QLQ-LC13）评分、外周血CD4⁺/CD8⁺比值、循环肿瘤细胞（CTCs）个数及血清肿瘤坏死因子受体相关因子1（TRAF1）、基质金属蛋白酶-14（MMP-14）、碱性成纤维细胞生长因子（bFGF）水平。结果 治疗后，治疗组ORR、DCR分别为65.57%和88.52%，分别较对照组的47.54%和73.77%均显著升高（P＜0.05）。治疗后，两组患者血清CEA、CYFRA21-1、SCC-Ag水平及咳嗽、气促、胸痛评分较治疗前均明显降低（P＜0.05），且治疗组明显低于对照组（P＜0.05）。治疗后，两组外周血CD4⁺/CD8⁺值明显增加，而CTCs和血清TRAF1、MMP-14、bFGF水平明显下降（P＜0.05），且治疗组这些指标均优于对照组（P＜0.05）。结论 采用华蟾素注射液联合PP方案治疗晚期肺腺癌，可从免疫调节、抑制转移、阻断促癌信号及抗血管生成多途径发挥协同增效作用，并一定程度降低副反应，进而促进患者症状、生活质量的改善，控制疾病进展。

Objective To investigate the clinical efficacy of Huachansu Injection combined with pemetrexed-cisplatin (PP) regimen in the treatment of advanced lung adenocarcinoma. Methods A total of 122 patients diagnosed with advanced lung adenocarcinoma admitted to the Hospital of Integrated Traditional Chinese and Western Medicine, Southern Medical University, from February 2023 to August 2025 were enrolled and randomly divided into a control group and a treatment group using a random number table, with 61 cases in each group. The control group received standard PP chemotherapy: intravenous pemetrexed disodium (500 mg/m²) and cisplatin (75 mg/m²) on the first day of each cycle. On the basis of the PP regimen, the treatment group received additional intravenous infusion of Huachansu Injection (20 mL diluted in 500 mL of 5% glucose solution) once daily. Each cycle lasted 21 days, and both groups completed four consecutive cycles of treatment. The objective response rate (ORR) and disease control rate (DCR) were evaluated. Pre- treatment and post-treatment comparisons were performed for serum tumor markers including carcinoembryonic antigen (CEA), cytokeratin 19 fragment 21-1 (CYFRA21-1), and squamous cell carcinoma antigen (SCC-Ag), EORTC QLQ-LC13 quality-of-life scores, peripheral blood CD4/CD8 ratio, circulating tumor cell (CTC) count, and serum levels of tumor necrosis factor receptor-associated factor 1 (TRAF1), matrix metalloproteinase-14 (MMP-14), and basic fibroblast growth factor (bFGF). Results After treatment, the treatment group achieved significantly higher ORR (65.57% vs 47.54%) and DCR (88.52% vs 73.77%) than the control group (P < 0.05). Both groups exhibited significant reductions in serum CEA, CYFRA21-1, SCC-Ag levels, as well as decreased scores of cough, shortness of breath and chest pain after treatment (P < 0.05), with more prominent improvements observed in the treatment group (P < 0.05). Additionally, the CD4⁺/CD8⁺ ratio was markedly elevated, while CTC counts and serum TRAF1, MMP-14 and bFGF levels were significantly decreased in both groups (P< 0.05); the treatment group demonstrated superior alterations in all these indicators relative to the control group (P < 0.05).Conclusion The combination of Huachansu Injection and PP chemotherapy exerts synergistic anti-tumor effects in advanced lung adenocarcinoma. This combinatorial strategy suppresses disease progression through multiple mechanisms, including immune modulation, inhibition of tumor metastasis, blockade of oncogenic signaling, and anti-angiogenesis. Moreover, it alleviates chemotherapy-related adverse reactions, improves clinical symptoms and quality of life, and achieves favorable therapeutic efficacy for advanced lung adenocarcinoma.

R979.1

厦门市卫生健康高质量发展中青年骨干人才项目（2024GZL-GG46）；广东省中医药局科研项目（20233005）；广东省中医药研究开发重点实验室开放基金项目（KFKT02-005）