参一胶囊联合免疫治疗和化疗在治疗老年晚期非小细胞肺癌患者中的临床研究

A clinical study on Shenyi capsule combined with immunotherapy and chemotherapy in treatment of elderly patients with ad-vanced non-small cell lung cancer

中文关键词: 老年, 非小细胞肺癌, 参一胶囊, 免疫治疗, 临床疗效, 化学治疗, T细胞亚群

英文关键词: elderly  non-small cell lung cancer  Shenyi capsule  immunotherapy  clinical efficacy  chemotherapy  T-cell subsets

中文摘要:

      目的 评估参一胶囊联合免疫治疗对晚期非小细胞肺癌(NSCLC)患者的疗效影响,通过分析检测晚期NSCLC患者外周血细胞因子、T淋巴细胞亚群及免疫抑制细胞的变化,初步阐明参一胶囊的作用机制,并为提高晚期NSCLC的整体疗效提供新的策略.方法 将2021年12月-2024年1月就诊于苏州市中医医院肿瘤内科的60例老年晚期NSCLC患者随机分为2组:观察组和对照组,每组30例.观察组给予参一胶囊联合免疫检查点抑制剂和化疗方案,而对照组仅给予免疫检查点抑制剂和化疗方案.经过12周治疗,比较2组的疗效,并进行统计分析.结果 治疗后,观察组CD3+、CD4+和 CD8+水平分别提高(10.68±2.14)％、(11.69±2.32％)、(7.96±1.83)％,均高于对照组(P＜0.05);观察组CD4+/CD8+比值高于对照组[(1.38±0.23)vs(0.95±0.17),P＜0.05)];观察组IL-6水平低于对照组[(23.17±4.26)μg/mL vs(33.18±5.37)μg/mL,P＜0.05)];观察组 CRP 和 TNF-α 水平降低幅度大于对照组(P＜0.05);观察组体质量改善率高于对照组(83.3％vs50.0％,P＜0.05);观察组不良反应发生率低于对照组(P＜0.05),骨髓抑制和胃肠不适等毒性均较轻(P＜0.05).结论 参一胶囊可增强晚期非小细胞肺癌患者的免疫治疗效果,减少骨髓抑制和胃肠不适的不良反应.

英文摘要:

      Objective To evaluate the therapeutic effects of Shenyi capsule combined with immunotherapy on patients with advanced non-small cell lung cancer(NSCLC),explore preliminarily the mechanism of action of Shenyi capsule based on the changes of cytokines,T lymphocyte subsets and immunosuppressive cells in peripheral blood of patients with advanced NSCLC,and provide new strategies for improving the overall efficacy of advanced NSCLC.Methods 60 elderly patients with advanced NSCLC admitted to Department of Medical Oncology,Traditional Chinese Medicine Hospital of Suzhou City from December 2021 to January 2024 were randomly divided into observation group and control group,with 30 patients in each group.The observation group was given Shenyi Capsule+immune checkpoint inhibitor+chemotherapy regimen,while the control group was given immune checkpoint inhibitor+chemotherapy regimen.After 12 weeks of treatment,the clinical effica-cy of the two groups was compared and statistically analyzed.Results After treatment,the levels of CD3+,CD4+,and CD8+in the observation group increased by(10.68±2.14)％,(11.69±2.32)％,and(7.96±1.83)％,respectively,which were significantly higher than those in the control group(P＜0.05).Additionally,the CD4+/CD8+ratio in the obser-vation group was significantly higher than that in the control group[(1.3 8±0.23)vs(0.95±0.17),P＜0.05)].The level of IL-6 in the observation group was significantly lower than that in the control group[(23.17±4.26)μg/mL vs(33.18±5.37)μg/mL,P＜0.05].The reduction in the levels of CRP and TNF-α in the observation group was greater than that in the control group,(P＜0.05).The weight improvement rate in the observation group was significantly higher than that in the con-trol group(83.3％vs 50.0％,P＜0.05).The incidence of adverse reactions in the observation group was lower than that in the control group(P＜0.05).The toxicity reactions such as bone marrow suppression and gastrointestinal discomfort in the ob-servation group were relatively mild(P＜0.05).Conclusion Shenyi capsule can enhance the efficacy of immunotherapy in patients with advanced NSCLC and reduce adverse effects such as bone marrow suppression and gastrointestinal discomfort.