微调3号方对肺脾气虚型晚期非小细胞肺癌患者生存结局的影响：一项回顾性队列研究

The Impact of WeiDiao No. 3 Formula on the Survival Outcomes of Patients with Advanced Non-Small Cell Lung Cancer of Lung-Spleen Qi Deficiency Type: A Retrospective Cohort Study

    摘要
  • 摘要:
    目的 观察中药复方微调3号方（WD-3）联合免疫及化疗对肺脾气虚型晚期非小细胞肺癌（Non-small cell lung cancer，NSCLC）患者生存结局的影响。
    方法 纳入对象为无锡市中医医院及江南大学附属医院肿瘤科在2020年1月1日至2025年3月1日收治的216例Ⅲb~Ⅳ期无驱动基因突变肺脾气虚型NSCLC患者，根据是否给予WD-3口服治疗（≥3个月）分为中药暴露组（n=98，WD-3+免疫联合化疗）和非中药暴露组（n=118，单纯免疫联合化疗），使用倾向性评分匹配（Propensity score matching，PSM）均衡基线资料，比较2组患者的总生存期（Overall survival，OS）、无进展生存期（Progression-free survival，PFS）及基线特征，以Cox比例风险回归模型分析暴露与结局的关联，并进行敏感性分析。
    结果 2组基线资料经PSM匹配后差异无统计学意义（P > 0.05）。匹配后，中药暴露组中位OS（32.92个月）、中位PFS（9.07个月）均长于非中药暴露组（23.24个月、7.89个月），差异有统计学意义（P < 0.05）。多因素分析纳入年龄、PD-L1表达、KPS评分、病理类型等作校正因素，评估WD3暴露与OS、PFS结局的独立关联。结果显示，WD3暴露与降低死亡风险（OS结局）、疾病进展风险（PFS结局）均具统计学意义，其中OS结局HR=0.626，95%CI：0.438~0.894，P=0.01；PFS结局HR=0.721，95%CI：0.535~0.972，P=0.032。敏感性分析显示结果稳健（E-value > 2.1）。
    结论 WD3联合免疫治疗与化疗可能延长无驱动基因突变肺脾气虚型晚期NSCLC患者的OS、PFS，减少死亡风险，取得良好的治疗效果。

     

    Abstract:
    OBJECTIVE To observe the effect of the Chinese herbal compound Weidiao No.3 Formula (WD-3) combined with immunotherapy and chemotherapy on survival outcomes in patients with advanced non-small cell lung cancer (NSCLC) with lung-spleen qi dificiency type.
    METHODS A total of 216 patients with stage Ⅲb–Ⅳ NSCLC without driver gene mutations and with lung-spleen qi vacuity pattern and admitted to the oncology departments of Wuxi Hospital of Traditional Chinese Medicine and Jiangnan University Affiliated Hospital between January 1, 2020, and March 1, 2025, were enrolled. Based on whether they received WD-3 oral treatment (≥3 months), they were divided into a Chinese medicine exposure group (n=98; WD-3+immunotherapy combined with chemotherapy) and a non-exposure group (n=118; immunotherapy combined with chemotherapy alone). Propensity score matching (PSM) was used to balance baseline characteristics. Overall survival (OS), progression-free survival (PFS), and baseline characteristics were compared between the two groups. Cox proportional hazards regression model was used to analyze the association between exposure and outcome, and sensitivity analysis was performed.
    RESULTS After PSM, there were no statistically significant differences in baseline characteristics between the two groups (P > 0.05). After matching, the median OS (32.92 months) and median PFS (9.07 months) in the Chinese medicine exposure group were longer than those in the non-exposure group (23.24 months and 7.89 months, respectively), with statistically significant differences (P < 0.05). Multivariate analysis was conducted, incorporating age, PD-L1 expression, KPS score, pathological type, and other factors as covariates to assess the independent association between WD3 exposure and OS and PFS outcomes. The results indicated that WD3 exposure was statistically significant in reducing the risk of death (OS outcome) and disease progression (PFS outcome). Specifically, for the OS outcome, the HR was 0.626, with a 95%CI of 0.438 to 0.894, and P=0.01; for the PFS outcome, the HR was 0.721, with a 95%CI of 0.535 to 0.972, and P=0.032. Sensitivity analysis showed robust results (E-value > 2.1).
    CONCLUSION WD-3 combined with immunotherapy and chemotherapy may prolong OS and PFS and reduce mortality risk in patients with advanced NSCLC without driver gene mutations and with lung-spleen qi dificiency type, achieves adequate therapeutic effects.

     

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