扶正治癌组方联合表皮生长因子受体酪氨酸激酶抑制剂治疗晚期非小细胞肺癌临床疗效观察  

Effects of Fuzheng Zhiai Formula combined with epidermal growth factor receptor tyrosine kinase inhibitors therapy for non-small cell lung cancer: A randomized controlled trial

作　　者：朱伟嵘[1] 高蓓莉[2] 焦丽静 许玲[3] 沈小珩[1] 阮铭[1] 吕玲玲[1] 张惟郁[1] 应海峰[1] 陈敬贤[1] 张洪 项轶[2] ZHU Wei-rong;GAO Bei-li;JIAO Li-jing;XU Ling;SHEN Xiao-heng;RUAN Ming;LYU Ling-ling;ZHANG Wei-yu;YING Hai-feng;CHEN Jing-xian;ZHANG Hong;XIANG Yi(Department of Traditional Chinese Medicine,Ruijin Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200025,China;Department of Respiratory Medicine,Ruijin Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200025,China;Department of Oncology,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Chinese Medicine,Shanghai 200437,China;Shanghai Jiaotong University School of Medicine,Shanghai 200025,China)

机构地区：[1]上海交通大学医学院附属瑞金医院中医科,上海200025 [2]上海交通大学医学院附属瑞金医院呼吸科,上海200025 [3]上海中医药大学附属岳阳中西医结合医院肿瘤科,上海200437 [4]上海交通大学医学院,上海200025

出　　处：《中华中医药杂志》2018年第8期3692-3697,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家中医临床研究基地业务建设科研专项课题(No.JDZX2012119)~~

摘　　要：目的:观察扶正治癌中药组方联合表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)靶向药物治疗晚期非小细胞肺癌的疗效及安全性。方法:采用双盲、随机、安慰剂对照的前瞻性临床研究方法,将60例伴有EGFR基因突变的晚期非小细胞肺腺癌一线或二线治疗患者按照1∶1比例随机分为2组:试验组(扶正治癌组方辨证中药+靶向治疗组)和对照组(安慰剂+靶向治疗组)。研究主要疗效指标为:无进展生存时间(PFS);次要疗效指标:总生存时间(OS);客观缓解率(ORR);肺癌症状量表(LSCC量表);中医症候评分;不良反应和安全性评估;组织或血液标本的EGRF基因外显子(E19~21)、Kras、Braf、PI3KCA、ALK基因突变和ROS1基因重排检测。结果:实际50例患者进入意向性分析(试验组28例,对照组22例)。试验组辨证分型气虚型患者中医临床证候改善显著优于对照组(P=0.001)。LSCC量表分析试验组症状改善显著优于对照组(P=0.001)。13例疾病进展患者进行基因突变动态监测,试验组未发现p.T790M耐药突变,对照组发现3例p.T790M突变率为42.86%。两组总体治疗相关药物不良反应发生率无显著差异。试验组严重药物不良反应发生率为6.67%,对照组为16.67%。结论:扶正治癌中药组方有延长TKI靶向治疗的晚期非小细胞肺腺癌患者PFS和OS的趋势,能够显著改善肺癌症状,提高生活质量,同时能够改善气虚型患者临床症候,以及减少严重不良反应事件发生。Objective： To evaluate the efficacy and safety of Fuzheng Zhiai Formula of combined with epidermal growth factor receptor tyrosine kinase inhibitors therapy in the treatment of non-small cell lung cancer. Methods： By double- blind, randomized, placebo-controlled prospective clinical research methods, 60 patients with advanced non-small cell lung adenocarcinoma with EGFR gene mutation were randomly divided into 2 groups according to 1 ： 1 proportions： The trial group （Fuzheng Zhiai Formula treatment combined with TKIs therapy） and the control group （placebo with TKIs therapy）. The major endpoint was Progression Free Survival （PFS）. The secondary study endpoints were Overall Survival （OS）, Objective response rates （ORR）, Lung cancer symptom scale （LSCC scale）, Clinical symptoms score of TCM, toxicity and safety assessment. The change of EGFR gene exon （E19~21）, Kras, Braf, PI3KCA, ALK gene mutations and ROS1 gene rearrangements in tissues or Peripheral blood samples were detected before and after the treatment. Results： The actual 50 cases were treated with intent-to treat （ITT） analysis, including 28 in the trail group and 22 in the control group. The improvement of clinical symptoms scorq of TCM in trial group was significantly better than that of the control group （P=0.001）. The improvement in symptoms of the, LSCC scale was significantly better than the control group （P=0.001）. Thirteen cases of disease progression in patients with gen, mutation monitoring, the trial group did not find p.T790 resistant mutations （0/6 cases）, the control group found 3 cases p.T790M the mutation rate was 42.86% （3/7 cases）. The overall incidence of adverse drug reactions （ADRs） had no significant differenc between the trial group and the control group. The 3-4 degree serious ADRs was 6.67% in the trial group and 16.67% in the control group. Conclusion： Fuzheng Zhial Formula has the tendency to prolong the PFS and OS in TKIs target therapy patients o advanced non-sma

关 键 词：非小细胞肺癌 扶正治癌组方 表皮生长因子受体酪氨酸激酶抑制剂 临床研究 

分 类 号：R734.2[医药卫生—肿瘤]