养阴解毒颗粒联合吉非替尼治疗表皮生长因子受体突变晚期肺腺癌阴虚型的临床研究  

Clinical study of Yangyin Jiedu Granules combined with Gefitinib in the treatment of patients with advanced lung adenocarcinoma of yin deficiency with EGFR mutation

作　　者：王雯珺 钦敬茹 张程程 杨鹭 汤哲伟 钱鑫乐 邓海滨[1] 杨佳 王中奇[1] WANG Wen-jun;QIN Jing-ru;ZHANG Cheng-cheng;YANG Lu;TANG Zhe-wei;QIAN Xin-le;DENG Hai-bin;YANG Jia;WANG Zhong-qi(Department of Oncology,Longhua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Department of Oncology,Northern Jiangsu People's Hospital,Yangzhou 225001,China)

机构地区：[1]上海中医药大学附属龙华医院肿瘤科,上海200032 [2]江苏省苏北人民医院肿瘤科,扬州225001

出　　处：《中华中医药杂志》2021年第4期2415-2418,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家中医药管理局国家中医临床研究基地业务建设科研专项(No.JDZX2015067);国家自然科学基金青年科学基金项目(No.81703855);上海市教育委员会科研创新计划项目(No.2017-01-07-00-10-E00064)。

摘　　要：目的:观察中药养阴解毒颗粒联合吉非替尼治疗表皮生长因子受体(EGFR)突变晚期肺腺癌阴虚型的临床疗效。方法:69例晚期肺腺癌患者随机分为治疗组35例和对照组34例。对照组口服吉非替尼,治疗组在口服吉非替尼的基础上联合养阴解毒颗粒,比较两组的临床疗效。结果:治疗组客观缓解率在第3、6、8个月时显著高于对照组(P<0.05);治疗组的无进展生存期和中位无进展生存期分别为12.70、12.40个月,对照组分别为8.58、8.20个月,两组比较差异均有统计学意义(P<0.01);治疗组的血清肿瘤标志物CEA在第3、6、9个月时下降情况较对照组显著(P<0.05);治疗组在改善生活质量和中医证候症状方面优于对照组,且不良事件的发生率低于对照组(P<0.05)。结论:养阴解毒颗粒能够提高吉非替尼治疗EGFR突变晚期肺腺癌阴虚型患者的疗效,值得临床广泛应用。Objective:To observe the clinical efficacy of Chinese medicine Yangyin Jiedu Granules combined with targeted drug Gefitinib in the treatment of patients with advanced lung adenocarcinoma of yin deficiency of EGFR mutation.Methods:A total of 69 patients were randomly assigned to the treatment group(35 cases)and the control group(34 cases).The control group was treated with Gefitinib,and the treatment group was given the Chinese medicine Yangyin Jiedu Granules with Gefitinib,and compare the clinical efficacy of the two groups.Results:The ORR was significantly higher in the treatment group than that in the control group at the 3 rd,6 th,and 8 th month(P<0.05).The PFS and mPFS of the control group was 12.70 months and 12.4 months respectively.The PFS and mPFS of the treatment group was 8.58 months and 8.20 months respectively.The difference between the two groups was statistically significant(P<0.01);The tumor marker CEA in the treatment group decreased significantly at the 3 rd,6 th,and 9 th months,and the difference was statistically significant(P<0.05);The treatment group was better than the control group in terms of quality of life and TCM syndromes and symptoms,and the incidence of adverse events was lower than the control group(P<0.05).Conclusion:Yangyin Jiedu Granules can improve the efficacy of Gefitinib in treating patients with advanced lung adenocarcinoma of yin deficiency with EGFR mutation and is worthy of extensive clinical application.

关 键 词：肺腺癌 表皮生长因子受体突变 养阴解毒颗粒 吉非替尼 临床疗效 疾病无进展生存期 

分 类 号：R734.2[医药卫生—肿瘤]