【目的】基于真实世界研究数据探讨中药联合程序性死亡受体1（PD-1）/程序性死亡配体1（PD-L1）抑制剂一线治疗对老 年非小细胞肺癌（NSCLC）患者无进展生存期（PFS）的影响，挖掘中药核心处方。【方法】回顾性分析2019 年1 月至2023 年 12 月中日友好医院收治的217 例老年NSCLC 患者的临床资料。采用Kaplan-Meier 法估算各组的中位PFS 并绘制生存曲线， Log-rank 检验比较组间中位PFS 的差异，采用Cox 回归模型分析影响老年NSCLC 患者PFS 预后的独立因素，记录并统计相 关不良事件。收集73 例中药联合PD-1/PD-L1 抑制剂一线治疗老年NSCLC 的临床病案，构建中药处方数据库，采用关联规 则及聚类分析等方法挖掘中药有效复方的临床用药特点和思路。【结果】（1）最终共纳入206 例老年NSCLC 患者，其中西医组 133 例（64.56%），中位PFS 为11.90 个月，第1、2、3 年的PFS 率分别为52.7%、26.9%、21.5%；中西医组73 例（35.44%）， 中位PFS 为18.83 个月，第1、2、3 年的PFS 率分别为59.7%、47.8%、40.1%，2 组患者的PFS 比较，差异有统计学意义（P = 0.013）。（2）单因素及多因素Cox 回归分析显示：临床分期、是否服用中药治疗与老年NSCLC 患者PFS 显著相关（P＜0.05 或 P＜0.01）。（3）中药复方共涉及中药296 味，19 种中药的使用频次超过100 次。高频中药经聚类分析后分为6 组，其中“黄芪、 党参、茯苓、白术、仙鹤草”为核心中药处方。【结论】中药联合PD-1/PD-L1 抑制剂一线治疗可显著延长老年NSCLC 患者的 中位PFS，减轻免疫相关不良事件，临床分期、是否服用中药治疗是影响老年NSCLC 患者PFS 的独立预后因素。以“黄芪、 党参、茯苓、白术、仙鹤草”为代表的核心中药处方，体现了中医“扶正补虚”的治疗思想。

Objective To investigate the effect of Chinese medicine combined with first-line programmed death-1 （PD-1）/programmed death-ligand 1（PD-L1）inhibitors on progression-free survival（PFS）in elderly patients with non-small cell lung cancer（NSCLC）based on real-world data，and to explore the core Chinese medicine prescription. Methods A retrospective analysis was conducted on the clinical data of 217 elderly NSCLC patients treated at China-Japan Friendship Hospital from January 2019 to December 2023. The Kaplan-Meier method was used to estimate the median PFS of each group and plot survival curves，and the Log-rank test was employed to compare the differences in median PFS between groups. Cox regression model was used to analyze independent factors influencing PFS prognosis in elderly NSCLC patients，and related adverse events were recorded and analyzed. Clinical records of 73 elderly NSCLC patients treated with Chinese medicine combined with first-line PD-1/PD-L1 inhibitors were collected to establish a Chinese medicine prescription database. Association rule analysis and cluster analysis were used to explore the clinical medication characteristics and principles of effective Chinese medicine compound formulas. Results（1）A total of 206 elderly NSCLC patients were finally included， with 133 cases（64.56%）in the western medicine group and 73 cases（35.44%）in the integrated Chinese medicine and western medicine group（shortened to intergrated group）. The median PFS was 11.90 months in the western medicine group，with 1-，2-，and 3-year PFS rates of 52.7%，26.9%，and 21.5%，respectively；the median PFS was 18.83 months in the integrated group，with 1-，2-，and 3-year PFS rates of 59.7%，47.8%，and 40.1%， respectively. The difference in PFS between the two groups was statistically significant（P = 0.013）.（2）Univariate and multivariate Cox regression analyses showed that clinical stage and whether receiving Chinese medicine treatment were significantly correlated with PFS in elderly NSCLC patients（P＜0.05 or P＜0.01）.（3）The Chinese medicine compound prescriptions involved a total of 296 herbs，with 19 herbs used more than 100 times. After cluster analysis，the high-frequency herbs were divided into six clusters，among which“Astragali Radix， Codonopsis Radix，Poria，Atractylodis Macrocephalae Rhizoma，Agrimoniae Herba”constituted the core prescription. Conclusion Chinese medicine combined with first-line PD-1/PD-L1 inhibitors significantly prolongs median PFS and reduces immune-related adverse events in elderly NSCLC patients. Clinical stage and whether receiving Chinese medicine treatment are independent prognostic factors for PFS. The core prescription represented by“Astragali Radix，Codonopsis Radix，Poria，Atractylodis Macrocephalae Rhizoma，Agrimoniae Herba” embodies the traditional Chinese medicine therapeutic principle of“strengthening vital qi and reinforcing deficiency”.

R273.342

国家自然科学基金项目（编号：82474329）；2024 年国家临床重点专科建设项目：胸外（肺癌）（“1+N”学科群模式）