基于生物标志物的非小细胞肺癌中医药精准 治疗
Precision Treatment of Non-Small Cell Lung Cancer with Traditional Chinese Medicine Based on Biomarkers
DOI: 10.12677/acm.2026.162652, PDF,    科研立项经费支持
作者: 陈美佳, 陈江龙：黑龙江中医药大学药学院，黑龙江 哈尔滨；朱 昱：中国医学科学院北京协和医学院药用植物研究所云南分所，北京；云南省南药可持续利用重点实验室，云南 景洪；苏锦华：西双版纳州食品药品检验所，云南 景洪；王金辉：西双版纳傣药研究所有限责任公司，云南 景洪；李 光*：黑龙江中医药大学药学院，黑龙江 哈尔滨；中国医学科学院北京协和医学院药用植物研究所云南分所，北京；云南省南药可持续利用重点实验室，云南 景洪；张 瑾*：中日友好医院胸外科，北京
关键词: 非小细胞肺癌；生物标志物；中医药；精准医学；肿瘤微环境；临床试验设计；Non-Small Cell Lung Cancer； Biomarkers； Traditional Chinese Medicine； Precision Medicine； Tumor Microenvironment； Clinical Trial Design
摘要: 晚期非小细胞肺癌(NSCLC)的临床治疗目前面临两大核心挑战：一是靶向治疗后的获得性耐药，主要涉及MET基因扩增介导的EGFR-TKI耐药等机制；二是肿瘤微环境(TME)免疫抑制状态导致的原发性免疫耐药。中医药(TCM)在协同西医治疗、逆转耐药及减轻毒副反应方面具有潜在的临床价值，但其现代应用受限于缺乏微观生物学指标的精确指导，导致治疗方案缺乏标准化。本文旨在构建一个基于生物标志物导向的中医药精准干预理论框架。该框架利用驱动基因突变状态、耐药信号通路激活情况、PD-L1表达水平及TME免疫细胞组成等现代生物标志物，作为中医药介入的客观依据，将中医宏观的“辨证论治”与西医微观的“分子分型”有机结合。本文系统综述了中药活性成分针对特定分子病理事件(如小檗碱抑制MET信号通路、灵芝多糖调节免疫微环境)的药理学机制及临床前证据，深入分析了从基础研究向临床转化过程中面临的药代动力学及标准化难题，并提出了基于生物标志物分层的创新临床试验设计策略(如伞式试验)，为推动中西医结合肺癌治疗向精准化、循证化发展提供理论依据。
Abstract: Clinical management of advanced non-small cell lung cancer (NSCLC) faces major hurdles: first, acquired drug resistance after targeted therapy, which mainly involves mechanisms such as EGFR-TKI resistance mediated by MET gene amplification; second, primary immune resistance caused by the immunosuppressive state of the tumor microenvironment (TME). Traditional Chinese medicine (TCM) has demonstrated significant potential in synergistic enhancement, resistance reversal, and toxicity reduction. However, its modern application is hindered by a lack of precise guidance from microscopic biological indicators, resulting in non-standardized treatment protocols. This paper aims to construct a biomarker-guided theoretical framework for precision TCM intervention. This framework utilizes driver gene mutation status, activated resistance signaling pathways, PD-L1 expression levels, and TME immune cell composition as objective evidence for TCM involvement, organically integrating the macro-level “syndrome differentiation and treatment” of TCM with the micro-level “molecular subtyping” of Western medicine. This systematic review examines the pharmacological mechanisms and preclinical evidence of active components in Chinese herbal medicines targeting specific molecular pathological events (e.g., berberine inhibiting MET signaling, Ganoderma lucidum polysaccharides modulating the immune microenvironment). It thoroughly analyzes pharmacokinetic and standardization challenges encountered during translation from basic research to clinical practice. Finally, innovative biomarker-stratified clinical trial strategies (such as umbrella trials) are proposed to provide a theoretical basis for promoting standardized and evidence-based integration of Chinese and Western medicine in lung cancer therapy.
文章引用：陈美佳, 朱昱, 苏锦华, 王金辉, 陈江龙, 李光, 张瑾. 基于生物标志物的非小细胞肺癌中医药精准 治疗[J]. 临床医学进展, 2026, 16(2): 2468-2477. https://doi.org/10.12677/acm.2026.162652

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