益气养阴散结方联合EGFR-TKIs治疗EGFR-TKIs继发耐药的晚期非小细胞肺癌的临床研究  

Clinical Study of Yiqi Yangyin Sanjie Decotion Combined with EGFR-TKIs for EGFR-TKIs Resistance in Non-small Cell Lung Cancer

作　　者：杨雪飞[1] 叶知锋[1] 张晓丽[1] 蒋璐[1] 郭俊华[1] 黄伶[1] 黄挺[1] YANG Xuefei;YE Zhifeng;ZHANG Xiaoli;JIANG Lu;GUO Junhua;HUANG Ling;HUANG Ting(Department of Oncology, Hangzhou Hospital of Traditional Chinese Medicine, Guangxing Hospital Affiliated to Zhejiang Medical University, Hangzhou 310000, Zhejiang, China)

机构地区：[1]浙江省中医药大学附属广兴医院(杭州市中医院)肿瘤科

出　　处：《中华中医药学刊》2018年第2期442-445,共4页Chinese Archives of Traditional Chinese Medicine

基　　金：浙江省中医药管理局项目(2013ZB088)

摘　　要：目的：观察中药益气养阴散结方联合EGFR-TKIs治疗EGFR-TKIs继发耐药的晚期非小细胞肺癌的临床疗效。方法：将EGFR-TKIs治疗耐药后的晚期非小细胞肺癌患者随机分为化疗组、EGFR-TKIs组及益气养阴散结方联合EGFR-TKIs组。化疗组为用多西他赛或培美曲塞联合或不联合顺铂/卡铂进行化学治疗2-4个周期,EGFR-TKIs组为继续用原EGFR-TKIs药物治疗,益气养阴散结方联合EGFR-TKIs组为同时用中药益气养阴散结方联合原EGFR-TKIs药物治疗至不能耐受或死亡。对各组的临床疗效、生存时间、临床症候疗效、不良反应及生活质量进行评估。结果：（1）益气养阴散结方联合EGFR-TKIs治疗组DCR明显延长达46.9%,EGFR-TKIs组DCR 29.6%,化疗组DCR 32.0%;（2）治疗后益气养阴散结方联合EGFR-TKIs治疗组与EGFRTKIs治疗组、化疗组比较,临床证候疗效改善具有统计学意义,在联合治疗组及EGFR-TKIs治疗组治疗后较治疗前临床证候也存在明显改善（P〈0.05）;（3）3组患者治疗后生活质量疗效等级改变观察,益气养阴散结方联合EGFR-TKIs治疗组优于EGFR-TKIs治疗组及化疗组（P=0.026）;（4）益气养阴散结方联合EGFR-TKIs治疗组中位PFS 4.8月,中位OS 29.4月,与EGFR-TKIs治疗组（中位PFS 3.9月,中位OS 26.1月）及化疗组（中位PFS 5.0月,中位OS 20.1月）相比,中位PFS无统计学差异,中位OS明显延长,具有统计学差异（P〈0.05）。结论：益气养阴散结方联合EGFR-TKIs能延长EGFR-TKIs继发耐药的晚期非小细胞肺癌生存期（OS和PFS）,与化疗组及EGFR-TKIs组相比可改善患者临床证候,改善生活质量,安全性良好,最终转化成生存的获益。Objective：To observe the clinical curative effect of Yiqi Yangyin Sanjie Decotion combined with EGFR - TKIs for EGFR - TKIs secondary resistance in non - small cell lung cancer. Methods ： EGFR - TKIs treatment resistant advanced non - small cell lung cancer patients were randomly divided into the chemotherapy group, the EGFR - TKIs group and Yiqi Yangyin Sanjie Decotion combined with EGFR - TKIs group. The chemotherapy group was treated with docetaxel/pemetrexed combined with cisplatin/carboplatin. The chemotherapy cycles were 2 - 4. The EGFR - TKIs group was continued to use the original EGFR -TKIs medication. Yiqi Yangyin Sanjie Decotion combined with EGFR - TKIs group was at the same time treated with Yiqi Yangyin Sanjie Decotion combined with EGFR - TKIs to the original EGFR -TKIs intolerance or death. The clinical efficacy, survival time, clinical symptoms, adverse reactions and quality of fife were assessed in each group. Results ： @In Yiqi Yangyin Sanjie Decotion combined with EGFR - TKIs treatment group, DCR was 46.9% ,29.6% in the EGFR - TKIs group and 32% in the chemotherapy group. @After treatment, clinical syndromes in the combined group were improved with statistical significance than those in the EGFR -TKIs group and the chemotherapy group. In the combined group and the EGFR - TKIs group after treatment, the clinical syndrome also had obvious improvement （ P 〈 0.05 ）. （~）Three groups＇ quality of life of the combined treatment group was much better than that of the EGFR - TKIs group and the chemotherapy group （P = 0. 026）. @The median PFS was 4.8 months and the median OS was 29.4 months in the combined group. In the EGFR- TKIs group （mPFS 3.9 months ,mOS 26.1 months ） and in the chemotherapy group （ mPFS 5.0 months, mOS 20.1 months）, the mPFS was prolonged but there was no significant difference among the three guoups. The mOS was significantly longer between the combined group and the EGFR- TKIs group or the chemotherapy group （P 〈 O. 05 ）. Conclusion： Yiqi Yang

关 键 词：非小细胞肺癌 表皮生长因子受体 酪氛酸激酶抑制剂 益气养阴散结方 耐药 

分 类 号：R734.2[医药卫生—肿瘤]