[摘 要] 目的：探索外周免疫功能状态与肺癌转移的关联，筛选可用于肺癌转移“正虚”评估的外周血免疫标志物。方法：回 顾性分析2023年3月至2025年4月期间上海中医药大学附属市中医医院收治的肺癌患者治疗前的外周血免疫标志物，根据是否 存在远处转移，将患者分为无转移组与转移组，比较两组间免疫细胞和细胞因子的表达差异。将单因素分析P < 0.05的外周血免 疫指标纳入多因素二元Logistic回归模型，以识别肺癌转移的独立预测因素。结果：共纳入193例肺癌患者（无转移组101例，转 移组92例），两组在性别、年龄、吸烟史、饮酒史、病理类型间的差异均无统计学意义（均P > 0.05）。单因素分析显示，无转移组与 转移组间有多项免疫指标存在显著差异（均P < 0.05），包括：淋巴细胞计数，CD3+ 、CD4+ 、CD8+ T、CD19+ B细胞及CD3- CD16+ 56+ NK细胞绝对计数，Treg细胞、CD8+ CD28+ Treg细胞、G-MDSC和CD3- CD16+ CD56+dim NK细胞百分率，以及细胞因子IL-1β、IL-6和 IL-10水平。将差异性指标行二元Logistic回归分析，提示外周血中Treg细胞和CD8+ CD28+ Treg细胞百分率是肺癌发生远处转移 的独立预测因素[OR = 1.193, 95% C（I 1.047, 1.36）, P < 0.01; OR = 0.978, 95% C（I 0.957, 0.999）, P < 0.05]。结论：外周血免疫功 能紊乱是肺癌转移“正虚”的生物学基础，本研究以量化指标证实外周免疫功能状态与肺癌转移的相关性，为“正虚伏毒”和“肿瘤 转移态”理论提供了实证。

[Abstract] Objective: To investigate the association between peripheral immune function status and lung cancer metastasis, and to identify peripheral blood immune biomarkers for ‘Deficiency of Vital Qi’assessment in lung cancer metastasis. Methods: A retrospective analysis was conducted on peripheral blood immune markers collected before treatment from lung cancer patients admitted into Shanghai Municipal Hospital of Traditional Chinese Medicine, affiliated to Shanghai University of Traditional Chinese Medicine, between March 2023 and April 2025. Patients were categorized into the non-metastatic and the metastatic groups based on the presence of distant metastasis, and the differences in the expressions of immune cells and cytokines between groups were compared. Peripheral blood immune markers with P < 0.05 in univariate analysis were incorporated into a multivariate binary logistic regression model to identify independent predictors of lung cancer metastasis. Results: A total of 193 lung cancer patients were included (101 in the non-metastatic group and 92 in the metastatic group). There were no statistically significant differences between the two groups in terms of gender, age, smoking history, drinking history, or pathological type (all P > 0.05). Univariate analysis revealed significant differences in multiple immune markers between the non-metastatic and metastatic groups (all P < 0.05), including: lymphocyte count, CD3+, CD4+, and CD8+ T, CD19+ B cells, absolute counts of CD3-CD16+CD56+ NK cells, percentages of Treg cells, CD8+CD28+ Treg cells, G-MDSC, and CD3-CD16+CD56+dim NK cells , and levels of cytokine IL-1β, IL-6, and IL-10. Binary logistic regression analysis of differential indicators suggested that the percentage of Treg cells and CD8+CD28+ Treg cells in peripheral blood were independent predictors of distant metastasis in lung cancer (OR = 1.193, 95% CI [1.047, 1.36], P < 0.01; OR = 0.978, 95% CI [0.957, 0.999], P < 0.05). Conclusion: Peripheral blood immune dysfunction is the biological basis for 'qi deficiency' in lung cancer metastasis. This study quantitatively demonstrates the correlation between peripheral immune function status and lung cancer metastasis, providing empirical evidence for the theories of 'qi deficiency and hidden toxicity' and 'metastatic state of tumors'.

[基金项目] 国家自然科学基金（No. 82174245）；第五批全国中医临床优秀人才研修项目〔No. 国中医药人教函[2022] 1号〕；上海市卫生健康领军 人才（No. 2022LJ014）；上海申康医院发展中心第二轮《促进市级医院临床技能与临床创新三年行动计划》研究型医师创新转化能力培训项目（No. SHDC2023CRD01）；2024年度上海市卫生健康委员会临床研究专项（No. 20244Y0166）；上海市2024年度“科技创新行动计划” 启明星培育（扬帆专项）（No. 24YF2741300）