益气养阴病证结合辨治肺癌表皮生长因子受体酪氨酸激酶抑制剂靶向治疗相关症状群的随机对照双盲临床研究  

Effects of the herbal formula based on disease-syndrome combination of benefiting qi and nourishing yin treatment on symptom clusters associated with EGFR-TKI targeted therapy for lung cancer patients:A randomized,double-blind study

作　　者：姚嘉麟 赵艺 焦丽静 王芹 李嘉旗 毕凌 徐建芳[3] 孙建立[4] 陈智伟[2] 朱伟嵘[5] 侯爱画 冯高华 贾英杰[8] 沈伟生[9] 李湧健[10] 张子文[11] 龚亚斌[1] 许玲[1] YAO Jia-in;ZHAO Yi;JIAO Li-jing;WANG Qin;LI Jia-qi;BI Ling;XU Jian-fang;SUN Jian-li;CHEN Zhi-wei;ZHU Wei-rong;HOU Ai-hua;FENG Gao-hua;JIA Ying-jie;SHEN Wei-sheng;LI Yong-jian;ZHANG Zi-wen;GONG Ya-bin;XU Ling(Department I of Oncology,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Lung Tumor Clinical Medical Center,Shanghai Chest Hospital,Shanghai Jiaotong University,Shanghai 200030,China;Department of Oncology,Shanghai Pulmonary Hospital,Tongji University,Shanghai 200433,China;Department of Oncology,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Department of TCM,Ruijin Hospital,Shanghai Jiaotong University,Shanghai 200025,China;Department of Oncology,Yantai Hospital of Traditional Chinese Medicine,Yantai 264013,China;Department of Oncology,Zhangjiagang Hospital of Traditional Chinese Medicine,Zhangjiagang 215699,China;Department of Oncology,First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300073,China;Department of Oncology,Jiangyin People's Hospital,Jiangyin 214499,China;Department of Oncology,Suzhou Hospital of Traditional Chinese Medicine,Suzhou 215007,China;Department of Oncology,Changshu No.2 People's Hospital,Changshu 215501,China)

机构地区：[1]上海中医药大学附属岳阳中西医结合医院肿瘤一科,上海200437 [2]上海交通大学附属胸科医院肺部肿瘤中心,上海200030 [3]同济大学附属上海市肺科医院肿瘤科,上海200433 [4]上海中医药大学附属龙华医院肿瘤科,上海200032 [5]上海交通大学医学院附属瑞金医院中医科,上海200025 [6]烟台市中医医院肿瘤科,烟台264013 [7]张家港市中医医院肿瘤科,张家港215699 [8]天津中医药大学第一附属医院肿瘤科,天津300073 [9]江阴市人民医院肿瘤科,江阴214499 [10]苏州市中医医院肿瘤科,苏州215007 [11]常熟市第二人民医院肿瘤科,常熟215501

出　　处：《中华中医药杂志》2023年第5期2470-2476,共7页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：中医药行业科研专项(No.201307006);国家中医药管理局中医药循证能力建设项目(No.2019XZZX-ZL004);上海市自然科学基金项目(No.20ZR1459400);上海申康医院发展中心临床三年行动计划项(No.SHDC2020CR1052B);上海市科学技术委员会项目(No.20Y21902000)。

摘　　要：目的:观察益气养阴病证结合辨治晚期肺腺癌表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)靶向治疗相关症状群的影响。方法:采用多中心、随机对照、双盲试验设计,收集拟接受EGFR-TKI靶向治疗的晚期肺腺癌患者451例,随机分为两组,最后纳入分析病例354例,试验组(中药+EGFR-TKI)185例和对照组(安慰剂+EGFR-TKI)169例。观察治疗前后中医证候总分、各症状评分及不良反应发生率。结果:治疗3、5、7个月时,试验组总有效率(65.79%、73.53%、77.78%)显著优于对照组(45.83%、48.39%、49.04%)(P<0.01)。治疗7个月时,试验组较对照组咳嗽、咯痰、气短、乏力、失眠、腹泻症状群显著改善(P<0.05);其中试验组总分、腹泻、乏力评分在各时间点均有显著改善(P<0.05,P<0.01);试验组瘙痒、皮疹发生率较对照组显著减少(P<0.05,P<0.01)。结论:益气养阴病证结合诊疗方案可改善肺腺癌EGFR-TKI靶向治疗相关症状群,减少EGFR-TKI不良反应的发生。Objective:To observe the effects of herbal formula based on disease-syndrome combination of benefting qi and nourishing yin on symptom clusters associated with epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI)targeted therapy in advanced lung adenocarcinoma.Methods:The study used a multicenter,randomized,controlled,double-blind trial design to collect 451 patients with advanced lung adenocarcinoma who would receive EGFR-TKI targeted therapy and were randomized into two groups,354 cases who completed the protocol were included in the final analysis:185 cases in the trial group(herbal formula+EGFR-TKI)and 169 cases in the control group(placebo+EGFR-TKI).The total score,each symptom scores of TCM syndrome scores,and the occurrence of adverse events were dynamically observed before and after treatment.Results:At 3,5 and 7 months of treatment,the total effective rate of the trial group(65.79%,73.53%and 77.78%)was significantly better than that of the control group(45.83%,48.39%and 49.04%)(P<0.01).At 7 months of treatment,the symptoms clusters of cough,sputum,shortness of breath,fatigue,insomnia and diarrhea were significantly improved in the trial group compared with the control group(P<0.05);the total effect,diarrhea,and fatigue scores were statistically different in the trial group at all time points(P<0.05,P<0.01);pruritus and skin rash were significantly reduced in the trial group compared with the control group(P<0.05,P<0.01).Conclusion:The herbal formula based on disease-syndrome combination of benefiting qi and nourishing yin can effectively improve the symptoms associated with EGFR-TKI targeted therapy for lung adenocarcinoma and reduce the occurrence of EGFR-TKI-related adverse event.

关 键 词：益气养阴 病证结合 肺腺癌 表皮生长因子受体酪氨酸激酶抑制剂 症状群 

分 类 号：R273[医药卫生—中西医结合]