扶正祛邪方联合EGFR-TKI治疗晚期肺腺癌的临床研究  

Clinical study of Fuzheng Quxie Formula combined with EGFR-TKI in the treatment of advanced lung adenocarcinoma

作　　者：许荣忠 李雁[1] 张玲[2] 方志红[1] 赵凡尘[1] 吕祥[1] XU Rongzhong;LI Yan;ZHANG Ling;FANG Zhihong;ZHAO Fanchen;LÜXiang(Department of Oncology,Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,200071,China;Shanghai Pulmonary Hospital,Shanghai,200433,China)

机构地区：[1]上海中医药大学附属市中医医院肿瘤科,上海200071 [2]上海市肺科医院,上海200433

出　　处：《肿瘤药学》2024年第6期723-730,共8页Anti-Tumor Pharmacy

基　　金：国家自然科学基金面上项目(81973795);上海市卫生健康委员会中医药科研项目(2022QN083);未来计划科技发展项目(WL-QNRC-2022005K、WL-HBQN-2021008K)。

摘　　要：目的 观察扶正祛邪方联合EGFR-TKI治疗晚期肺腺癌的临床疗效,探索晚期非小细胞肺癌的中西医结合诊疗方案。方法 采用前瞻性队列研究方法,共纳入448例晚期肺腺癌患者。其中,上海中医药大学附属市中医医院的患者设为观察组(扶正祛邪方+EGFR-TKI组),上海市胸科医院患者设为对照组(EGFR-TKI组)。观察两组患者的临床疗效、无进展生存期(PFS)、安全性及生活质量。结果 扶正祛邪方+EGFR-TKI组患者中位PFS长于EGFR-TKI组(14.2个月vs. 10.43个月)(P<0.05)。在EGFR-TKI一线治疗亚组、19号外显子缺失亚组、21号外显子突变亚组及吉非替尼治疗亚组中,扶正祛邪方联合EGFR-TKI可明显延长患者中位PFS(P<0.05);而在二线治疗方案亚组及厄洛替尼、埃克替尼治疗亚组患者中尚未发现明显益处(P>0.05)。单因素分析显示,扶正祛邪方干预、性别、年龄、吸烟史、化疗与患者PFS相关(P<0.05);多因素回归分析显示,扶正祛邪方是晚期EGFR突变患者PFS的独立保护因素(P<0.05),而吸烟是PFS的危险因素(P<0.05)。结论 扶正祛邪方联合EGFR-TKI能够延长晚期肺腺癌患者的PFS,并延缓TKI药物的耐药。Objective To observe the clinical efficacy of Fuzheng Quxie Formula(扶正祛邪方)combined with EGFR-TKI in the treatment of advanced lung adenocarcinoma,and to explore the integrated traditional Chinese and Western medi-cine diagnosis and treatment of advanced non-small cell lung cancer.Methods A total of 448 patients with advanced lung adenocarcinoma were enrolled in this prospective cohort study.Among them,the patients from Shanghai Traditional Chi-nese Medicine Hospital were selected as the observation group(Fuzheng Quxie Formula+EGFR-TKI group),and the pa-tients from Shanghai Chest Hospital were selected as the control group(EGFR-TKI group).The clinical efficacy,progres-sion-free survival(PFS),safety and quality of life of the two groups were observed.Results The median PFS of Fuzheng Quxie Formula+EGFR-TKI group was longer than that of EGFR-TKI group(14.2 months vs.10.43 months)(P<0.05).Fu-zheng Quxie Formula combined with EGFR-TKI significantly prolonged the median PFS of patients in the EGFR-TKI first-line treatment subgroup,exon 19 deletion subgroup,exon 21 mutation subgroup and gefitinib treatment subgroup(P<0.05).However,no significant benefit was found in patients in the second-line treatment subgroup,the erlotinib treatment subgroup and the icotinib treatment subgroup(P>0.05).Univariate analysis showed that Fuzheng Quxie Formula,gender,age,smoking history,and chemotherapy were associated with PFS(P<0.05).Multivariate regression analysis showed that Fuzheng Quxie Formula was an independent protective factor for PFS in patients with EGFR mutations in advanced stage(P<0.05),while smoking was a risk factor for PFS(P<0.05).Conclusion Fuzheng Quxie Formula combined with EGFR-TKI treatment can prolong the progression-free survival of patients with advanced lung adenocarcinoma,and delay the drug resistance of TKI.

关 键 词：肺腺癌 扶正祛邪方 靶向药 耐药 临床疗效 

分 类 号：R734.2[医药卫生—肿瘤] R979.1[医药卫生—临床医学]