分阶段中药辅助靶向治疗EGFR敏感突变的非小细胞肺癌的临床研究  

Clinical Study of Staged Chinese Herbal Medicine Assisted Target Therapy in the Treatment of Non Small Cell Lung Cancer with EGFR Sensitive Mutation

作　　者：鞠立霞[1] 韩明权[1] 苏晋梅[1] 张勤[1] 屠洪斌[1] 董志毅[1] 张素芳[1] 

机构地区：[1]同济大学附属上海市肺科医院中西医结合科,上海200433

出　　处：《上海中医药大学学报》2017年第3期18-22,共5页Academic Journal of Shanghai University of Traditional Chinese Medicine

基　　金：国家自然科学基金青年基金资助项目(81207106);上海市科委中医引导项目(14401932200;12401907500);上海市卫计委科研课题立项项目(20124Y123);上海市卫计委中医药科研课题资助项目(2012L051A)

摘　　要：目的:评价分阶段中药辅助靶向药物治疗非小细胞肺癌的疗效和安全性。方法:纳入92例非小细胞肺癌患者,随机分为治疗组(46例)和对照组(46例)。两组均予表皮生长因子受体酪氨酸激酶抑制剂(epidermal growth factor receptor tyrosine kinase inhibitors,EGFR-TKIs)治疗,治疗组在服用EGFR-TKIs药物初始3个月内给予益气健脾、清热祛湿方药治疗,3个月后给予益气养阴方药治疗。治疗前后评估两组患者的Karnofsky功能状态(Karnofsky Performance Status,KPS)评分,治疗开始后1个月评估临床疗效,治疗过程中记录皮疹发生情况,比较两组患者的疾病无进展生存期(progression-free survival,PFS)。结果:治疗组的平均PFS为(13.58±5.07)个月,对照组为(10.02±2.85)个月,治疗组患者的PFS较对照组明显延长(P<0.01)。治疗过程中,治疗组的皮疹发生率为66.7%,对照组为82.9%,治疗组的皮疹发生率明显低于对照组(P<0.05),且治疗组的皮疹发生情况较对照组明显减轻(P<0.05)。治疗1个月后,两组患者的临床疗效比较,差异无统计学意义(P>0.05)。治疗后,两组患者的KPS评分较治疗前均明显升高(P<0.05),且治疗组患者的KPS评分明显高于对照组(P<0.05)。结论:分阶段中药辅助靶向药物治疗非小细胞肺癌可减轻患者的皮肤毒性,改善其生存质量,且可延迟患者对EGFR-TKIs耐药的发生时间。Objective： To evaluate the efficacy and safety of staged Chinese herbal medicine assisted target therapy in the treatment of non small cell lung cancer （ NSCLC ）. Methods ： Ninety-two subjects with NSCLC were selected and randomly divided into the treatment group （46 cases） and the control group （46 cases）. The patients in both groups were treated with epidermal growth factor receptor tyrosine kinase inhibitors （EGFR-TKIs）. The patients in the treatment group were also treated with prescriptions of benefiting qi and strengthening spleen and clearing-heat and eliminating dampness within initial 3 months during taking EGFR-TKIs, and received prescriptions of benefiting qi and nourishing yin for another 3 months. The score of Karnofsky performance status （KPS） in the two groups were assessed before and after treatment. The clinical efficacy after treatment for one month was evaluated. The skin rash was recorded in the course of treatment and the progression-free survival （PFS） was compared between the two groups. Results ： The average PFS in the treatment group was （ 13.58 ±5.07 ） months, and the average PFS in the control group was （ 10.02 ± 2.85 ） months. The PFS of the treatment group was significantly longer than that of the control group（P 〈 0.01 ）. In the treatment course, the incidence of rash in the treatment and the control group were 66.7% and 82.9% respectively, and both the incidence and severity of the rash in the treatment group were significantly alleviated compared with the control group （ P 〈 0.05 ）. There were no statistically significant differences on the clinical efficacy between the two groups after treatment for one month （ P 〉 0.05 ）. The KPS score in both groups was significantly increased compared with treatment before （ P 〈 0.05 ） and the KPS score in the treatment group was significantly higher than that in the control group after treatment （ P 〈 0.05 ）. Conclusion ： The staged Chinese herbal medicine assisted target

关 键 词：非小细胞肺癌 靶向治疗 中医药 分阶段治疗 表皮生长因子受体 

分 类 号：R734.2[医药卫生—肿瘤]