艾迪注射液联合PP方案治疗Ⅳ期非小细胞肺癌的临床研究  

Efficacy of Aidi injection combined with PP regimen in treatment of stageⅣnon-small-cell lung cancer

作　　者：蒙冲[1] 陈永倖[2] 谢甜[1] Meng Chong;Chen Yongxing;Xie Tian(Department of Medicine,Hainan Provincial People′s Hospital,the Affiliated Hainan Hospital of Hainan Medical College,Haikou 570311,China;Department of Respiratory and Critical Care,Hainan Provincial People′s Hospital,the Affiliated Hainan Hospital of Hainan Medical College,Haikou 570311,China)

机构地区：[1]海南省人民医院海南医学院附属海南医院内科,海口570311 [2]海南省人民医院海南医学院附属海南医院呼吸与危重症医学科,海口570311

出　　处：《国际呼吸杂志》2021年第20期1551-1556,共6页International Journal of Respiration

基　　金：海南省卫生健康行业科研项目(20A200127)。

摘　　要：目的探讨艾迪注射液联合培美曲塞+顺铂方案(PP方案)治疗Ⅳ期非小细胞肺癌(NSCLC)的抗肿瘤疗效以及其对患者血清白细胞介素(IL)-1β、IL-6和外周血T淋巴细胞亚群水平的影响。方法前瞻性研究。选取2016年1月至2020年1月海南省人民医院收治的96例Ⅳ期NSCLC患者,随机将其分成观察组48例和对照组48例。其中对照组采取PP方案化疗,观察组在对照组基础上同期采用艾迪注射液治疗,连续治疗2个周期后评价2组近期疗效及安全性。并比较2组远期生存情况。结果2组治疗后血清细胞角蛋白片段19(CYFRA21-1)、癌胚抗原(CEA)、IL-1β和IL-6浓度均显著下降(P值均<0.05)。与对照组比较,观察组CYFRA21-1、CEA、IL-1β和IL-6降低更显著(P值均<0.05)。治疗后,与对照组比较,观察组KPS功能状态量表卡氏(KPS)评分的改善更显著(P<0.05)。观察组2~3级白细胞减少、血小板减少及胃肠道反应的发生率分别为37.5%(18/48)、6.3%(3/48)、14.6%(7/48),均显著低于对照组[56.3%(28/48)、20.8%(10/48)、33.3%(16/48),P值均<0.05]。观察组中位无进展生存期(PFS)和中位总生存期(OS)分别为4.9个月、20.1个月,较对照组(3.4个月、16.4个月)均显著延长(P值均<0.05)。结论将艾迪注射液用于Ⅳ期NSCLC患者PP方案化疗中表现出良好的增效减毒作用,能进一步抑制患者血清IL-1β、IL-6的表达,增强机体免疫功能,并可使患者在远期生存方面获益。Objective To investigate the antitumor effect of Aidi injection combined with pemetrexed plus cisplatin(PP regimen)in treatment of patients with stageⅣnon-small-cell lung carcinoma(NSCLC)and its effect on levels of serum interleukin(IL)-1B,IL-6 and T lymphocyte subsets in peripheral blood.Methods Perspective reseach was performed 96 patients with NSCLC stageⅣfrom Hainan Provincial People′s Hospital in January 2016 to January 2020.The patients were randomly divided into observation group(n=48)and control group(n=48).The control group got treated with PP regimen and the observation group was treated with Aidi injection on the basis of the control group.The short-term efficacy and safety of two groups were evaluated after two cycles of continuous treatment.The long-term survival was also compared in two groups.Results Serum cytokeratin fragment 19(CYFRA21-1),carcinoembryonic antigen(CEA),IL-1B and IL-6 significantly decreased after treatment in both groups(all P<0.05).CYFRA21-1,CEA,IL-1B and IL-6 decreased more significantly in observation group than in control group(all P<0.05).Karnofsky Performance Status(KPS)score of observation group was improved more significantly than that of control group(P<0.05).The incidences of grade 2-3 leukopenia,thrombocytopenia and gastrointestinal reactions were significantly lower,respectively 37.5%(18/48),6.3%(3/48)and 14.6%(7/48)in observation group than in control group,as 56.3%(28/48),20.8%(10/48),33.3%(16/48)(all P<0.05).The median progression-free survival(PFS),and median overall survival(OS)in observation group were 4.9 months and 20.1 months,which were significantly longer than in control group,3.4 months and 16.4 months(both P<0.05).Conclusions The application of Aidi injection combined with PP regimen in patients with NSCLC stageⅣshowed good effect of efficacy and less toxicity,which can further inhibit serum IL-1βand IL-6 and enhance the immune function,and the therapy can also benefit the patients in the long-term survival.

关 键 词：癌 非小细胞肺癌 抗肿瘤联合化疗方案 顺铂 培美曲塞 角蛋白质类 生物标记 肿瘤 细胞因子类 

分 类 号：R734.2[医药卫生—肿瘤]