回生口服液联合化疗、免疫治疗调节PD-1/PD-L1信号通路对晚期NSCLC的效果及安全性  

Efficacy and safety of Huisheng oral liquid combined with chemotherapy and immunotherapy on advanced non-small cell lung cancer by regulating the PD-1/PD-L1 signaling pathway

作　　者：赵微微 ZHAO Weiwei(Department of Oncology,Infectious Diseases Hospital of Heilongjiang Province,Heilongjiang,Harbin 150500,China)

机构地区：[1]黑龙江省传染病防治院肿瘤内科,哈尔滨市150500

出　　处：《河北医药》2023年第23期3535-3539,3544,共6页Hebei Medical Journal

基　　金：黑龙江省卫生健康委科研课题(编号:20220303101133)。

摘　　要：目的探讨回生口服液联合免疫治疗、化疗通过调节PD-1/PD-L1信号通路治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的疗效及安全性。方法选取2019年2月至2020年8月60例晚期NSCLC患者,随机分为2组,每组30例。对照组予以信迪利单抗联合紫杉醇+卡铂化疗方案,观察组于对照组基础上予以回生口服液治疗。21 d为1个周期,直至4周期结束。比较2组治疗前、治疗2个周期、治疗4个周期血清肿瘤标志物[细胞角蛋白19片段抗原21-1(CYDRA21-1)、人鳞状细胞癌相关抗原(SCCAg)、癌胚抗原(CEA)]、T淋巴细胞亚群(CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+))、程序性死亡受体(PD)-1/PD-L1信号通路相关指标及临床疗效、安全性、生活质量改善情况、无进展生存期(PFS)、总生存期(OS)。结果观察组客观缓解率(ORR)、疾病控制率(DCR)分别为73.33%、93.33%,高于对照组的46.67%、73.33%(P<0.05);观察组骨髓抑制、脱发、胃肠道反应发生率分别为16.67%、16.67%、36.67%低于对照组43.33%、50.00%、70.00%(P<0.05);观察组生活质量改善率56.67%,高于对照组的30.00%(P<0.05);治疗2、4个周期后观察组血清CYDRA21-1、SCCAg及CEA水平较对照组下降(P<0.05);治疗2、4个周期后观察组CD3^(+)、CD4^(+)及CD4^(+)/CD8^(+)较对照组升高(P<0.05);治疗2、4个周期后观察组外周血CD+4T细胞PD-1、PD-L1水平较对照组下降(P<0.05);观察组中位PFS、中位OS分别为8个月、12个月长于对照组的6个月、9个月(P<0.05)。结论回生口服液联合免疫治疗、化疗能改善晚期NSCLC患者生活质量,调节患者免疫功能,抑制血清肿瘤相关因子表达,减轻部分化疗不良反应,延长患者生存期,疗效确切,这可能与调节PD-1/PD-L1信号通路有关。Objective To investigate the efficacy and safety of Huisheng oral liquid combined with immunotherapy and chemotherapy in the treatment of advanced non-small cell lung cancer(NSCLC)by regulating the programmed cell death protein 1/programmed cell death ligand 1(PD-1/PD-L1)signaling pathway.Methods A total of 60 patients with advanced NSCLC in our hospital from February 2019 to August 2020 were randomly divided into control group(n=30)and observation group(n=30).All patients were given sintilimab combined with chemotherapy(carboplatin plus paclitaxel),and those in the observation group were additionally given Huisheng oral liquid.Patients were treated with 4 cycles,with 21 days per cycle.Serum tumor markers(cytokeratin 19 fragment antigen 21-1[CYDRA21-1],human squamous cell carcinoma associated antigen(SCCAg),carcinoembryonic antigen[CEA]),T lymphocyte subsets(CD3^(+),CD4^(+),CD4^(+)/CD8^(+)),and the PD-1/PD-L1 signaling pathway were compared between the two groups before treatment,and after 2 and 4 treatment cycles.In addition,the efficacy,safety,improvement of quality of life,progression-free survival(PFS),and overall survival(OS)were assessed.Results The objective remission rate(ORR,73.33%vs 46.67%)and disease control rate(DCR,93.33%vs 73.33%)in the observation group were significantly higher than those in the control group(P<0.05).The incidence rates of bone marrow suppression(16.67%vs 43.33%),alopecia(16.67%vs 50.00%)and gastrointestinal reaction(36.67%vs 70.00%)in the observation group were significantly lower than those in the control group(P<0.05).The improvement rate of quality of life in observation group was significantly higher than that in control group(56.67%vs 30.00%,P<0.05).After 2 and 4 cycles of treatment,the serum levels of CYDRA21-1,SCCAg and CEA in the observation group were significantly lower than those in control group(P<0.05).The levels of CD3^(+),CD4^(+)and CD4^(+)/CD8^(+)in the observation group were significantly higher than those in control group(P<0.05).PD-1 and PD-L1 levels in periphe

关 键 词：非小细胞肺癌 信迪利单抗 化疗 回生口服液 肿瘤标志物 生存期 PD-1/PD-L1信号通路 

分 类 号：R734.2[医药卫生—肿瘤]