【摘要】 目的：评估程序性死亡蛋白1(PD-1)/程序性死亡配体1(PD-L1)免疫抑制剂联合扶正祛邪方治疗晚期非小细胞肺癌（NSCLC）的有效性、安全性，以及疗效预测因素。方法：回顾性分析92例经病理证实、TNM分期为Ⅲ～Ⅳ期的NSCLC患者，均行至少2个周期的PD-1/PD-L1抑制剂联合扶正祛邪方治疗。收集首次免疫治疗开始前的临床资料及影像学特征，根据实体瘤免疫疗效评价标准（iRECIST）评估治疗效果，主要结局指标为总生存期（OS）和无进展生存期（PFS）。通过Kaplan-Meier法绘制生存曲线，评估不同因素的中位OS和PFS。采用单因素和多因素Cox回归分析确定OS和PFS的独立危险因素和保护因素。结果：免疫联合中药治疗6个月后疾病控制率为62.0%(57/92)，客观缓解率为43.5%(40/92)。中位OS为31(95%CI 21.2～40.8)个月，中位PFS为20(95%CI 9.2～30.7)个月。一线免疫联合中药治疗33例，中位OS为31(95%CI 21.5～40.5)个月，中位PFS为30(95%CI 8.2～31.8)个月。单因素分析表明，TNM分期、肝转移、基线中性粒细胞与淋巴细胞比率（NLR）及影像组学评分是OS的影响因素；多因素Cox回归分析显示，肝转移、影像组学评分（<0.492）是OS的独立危险因素（均P<0.05）。单因素分析表明，TNM分期、肝转移、基线NLR及免疫治疗线数是PFS的影响因素；多因素Cox回归分析表明，TNM分期Ⅲ期及一线免疫联合中药治疗是PFS的独立保护因素（均P<0.05）。免疫相关不良反应发生率25.0%(23/92),G3及以上不良反应发生率2.2%(2/92)，未发生免疫导致死亡的不良事件。结论：PD-1/PD-L1免疫抑制剂联合扶正祛邪方治疗晚期NSCLC具有一定有效性及安全性。肝转移和影像组学评分（<0.492）是OS的独立危险因素，TNM分期Ⅲ期和一线免疫联合中药治疗为PFS的独立保护因素。影像组学有助于评估中西医结合治疗晚期NSCLC的预后。更多还原

【Abstract】 Objective:To evaluate the efficacy and safety of the combination of PD-1/PD-L1 inhibitors with Fuzheng Quxie Formula in the treatment of advanced non-small cell lung cancer(NSCLC). To explore the potential predictive factors for treatment response. Methods:A retrospective analysis was conducted on 92 patients with pathologically confirmed TNM stage Ⅲ/Ⅳ NSCLC. All patients received at least two cycles of treatment with PD-1/PD-L1 inhibitors combined with Fuzheng Quxie Formula. Clinical data and imaging features were collected prior to the initiation of the first immunotherapy cycle. Treatment outcomes were assessed according to the immune-related response evaluation criteria for solid tumors(iRECIST). The primary endpoints were overall survival(OS) and progression-free survival(PFS). The Kaplan-Meier method was used to plot survival curves,and the Log-rank test was employed to evaluate the impact of various factors on OS and PFS. Univariate and multivariate Cox regression analyses were performed to identify the independent risk factors and protective factors. Results:After 6-month treatment with inhibitors and traditional Chinese medicine(TCM),the disease control rate(DCR) was 62.0%(57/92),the objective response rate(ORR) was 43.5%(40/92). The median OS was 31(95%CI 21.2—40.8) months,and the median PFS was 20(95%CI 9.2—30.7) months. Among the 33 patients who received first-line immunotherapy combined with TCM,the median OS was 31(95%CI 21.5—40.5) months,and the median PFS was 30(95%CI 8.2—31.8) months. Univariate analysis showed that TNM staging,liver metastasis,baseline NLR and the radiomics score(Rad-score) were the influencing factors for OS,while multivariate Cox regression analysis showed that liver metastasis and Rad-score less than 0.492 were the independent risk factors for OS(all P<0.05). Univariate analysis showed that TNM staging,liver metastasis,baseline NLR and the treatment lines were the influencing factors for PFS,while multivariate Cox regression analysis showed that TNM stage Ⅲ and first-line treatment combined with TCM were the independent protective factors for PFS(both P<0.05). The incidence of immune-related adverse events was 25.0%(23/92),with G3 or higher grade adverse reactions occurring in 2.2%(2/92),and no immune-related deaths were observed. Conclusions:The combination of PD-1/PD-L1 inhibitors with Fuzheng Quxie Formula has an efficacy and safety in the treatment of advanced NSCLC. Liver metastasis and Rad-score less than 0.492 are the independent risk factors for OS,while TNM stage Ⅲ and the first-line treatment combined with TCM are the protective factors for PFS. Radiomics can help in the prognostic value of integrative treatment combining traditional Chinese and Western medicine.更多还原