益气养阴解毒方对EGFR-TKIs治疗患者外周血sPD-L1水平的影响及预后分析  

Effect of Yiqi Yangyin Jiedu Prescription on sPD-L1 in Peripheral Blood of Patients Treated with EGFR-TKIs and Prognosis Analysis

作　　者：沈丽萍[1] 蔡雨晴 文艳萍 姜怡[1] 刘苓霜[1] SHEN Liping;CAI Yuqing;WEN Yanping;JIANG Yi;LIU Lingshuang(Longhua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)

机构地区：[1]上海中医药大学附属龙华医院,上海200032

出　　处：《中国实验方剂学杂志》2025年第1期219-226,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：上海市自然科学基金项目(21ZR1463700);上海市中医肿瘤临床医学研究中心项目(21MC1930500)。

摘　　要：目的:观察可溶性程序性死亡因子配体-1(sPD-L1)对表皮生长因子受体抑制剂(EGFR-TKIs)治疗晚期肺腺癌患者的预后及益气养阴解毒方干预后的影响。方法:采用前瞻性队列对照研究方法,纳入2021年5月1日至2023年6月30日龙华医院肿瘤科、上海胸科医院就诊,一线接受EGFR-TKIs治疗的患者,在经过1个月的治疗后疗效评价为未进展且辨证属于气阴两虚证,根据是否联合益气养阴解毒方,分为暴露组(EGFR-TKIs联合益气养阴解毒方)和非暴露组(单用EGFR-TKIs),治疗直至疾病进展或死亡或出现不能耐受的不良反应,最终选取EGFR-TKIs治疗后出现疾病进展的患者入组。应用酶联免疫吸附测定法(ELISA)检测患者入组时和疾病进展时患者sPD-L1的水平,Cox风险比例模型分析影响患者EGFR-TKIs治疗疾病进展的独立预后因素。结果:最终选取EGFR-TKIs治疗后出现疾病进展的患者90例(暴露组39例,非暴露组51例)。90例患者在入组时和疾病进展时血清sPD-L1水平分别为12.06(27.54)ng·L^(-1)和41.99(62.93)ng·L^(-1),与入组时比较,进展时患者血清sPD-L1水平显著升高(P<0.01)。暴露组患者入组时和疾病进展时血清sPD-L1的水平分别12.27(24.78)ng·L^(-1)和29.57(61.12)ng·L^(-1),非暴露组患者入组时和疾病进展时血清sPD-L1水平分别为11.81(28.46)ng·L^(-1)和49.54(74.12)ng·L^(-1),与入组时比较,两组患者疾病进展时sPD-L1水平均显著升高(P<0.01);且疾病进展时,与非暴露组比较,暴露组患者sPD-L1水平显著降低(P<0.01)。Cox多因素分析显示,入组时sPD-L1水平及年龄与患者的无进展生存时间(PFS)有关,低水平sPD-L1(<12.06 ng·L^(-1))较高水平患者延长EGFR-TKI治疗的PFS(P<0.05),降低疾病进展风险。结论:sPD-L1水平的升高是EGFR-TKIs远期疗效的不良预后因素,益气养阴解毒方可下调EGFR-TKIs治疗患者的sPD-L1水平。Objective:To observe the prognosis effect of soluble programmed death ligand-1(sPD-L1)in treating patients with advanced lung adenocarcinoma treated with epidermal growth factor receptor-tyrosine kinase inhibitors(EGFR-TKIs)and the influence of Yiqi Yangyin Jiedu prescription.Method:A prospective cohort-controlled study was conducted to enroll patients treated with EGFR-TKIs in the first line of treatment,who were admitted to the Oncology Department of Longhua Hospital and Shanghai Chest Hospital from May 1st,2021 to June 30th,2023,and they were evaluated as non-progressive and identified with deficiency of Qi and Yin after one month of treatment.The patients were divided into an exposed group(EGFR-TKIs combined with Yiqi Yangyin Jiedu prescription)and a non-exposed group(EGFR-TKIs alone)according to whether or not they were treated with Yiqi Yangyin Jiedu prescription and were treated until disease progression,or death and intolerable adverse reactions occurred.The enzyme-linked immunosorbent assay(ELISA)was applied to detect the level of sPD-L1 in patients at the time of enrollment and disease progression,and Cox risk proportionality model was used to analyze the independent prognostic factors affecting disease progression of patients treated with EGFR-TKIs.Result:A total of 90 patients(39 in the exposed group and 51 in the non-exposed group)undergoing disease progression after EGFR-TKI treatment were enrolled.At the time of enrolment and after disease progression,the levels of serum sPD-L1 in the 90 patients were 12.06(27.54)ng·L^(-1) and 41.99(62.93)ng·L^(-1),respectively.Compared with that at the time of enrollment,the serum sPD-L1 level in the 90 patients was significantly increased after disease progression(P<0.01).The serum sPD-L1 level in patients in the exposed group was 12.27(24.78)ng·L^(-1) and 29.57(61.12)ng·L^(-1) respectively at the time of enrolment and after disease progression.In the non-exposed group,patients had serum sPD-L1 levels of 11.81(28.46)ng·L^(-1) and 49.54(74.12)ng·L^(-1) respe

关 键 词：可溶性程序性死亡因子配体-1 表皮生长因子受体抑制剂(EGFR-TKIs) 肺腺癌 益气养阴解毒方 预后 

分 类 号：R259[医药卫生—中西医结合] R273[医药卫生—中医内科学] R730.5[医药卫生—中医学]