益气养阴解毒方联合埃克替尼治疗老年晚期EGFR突变肺腺癌的临床研究  

Clinical study on Yiqi Yangyin Jiedu Decoction combined with icotinib in the treatment of elderly patients with advanced EGFR-mutant lung adenocarcinoma

作　　者：蒙家泉 焦丽静 姚嘉麟 李嘉旗 龚亚斌[1] 许玲[1,3] MENG Jiaquan;JIAO Lijing;YAO Jialin;LI Jiaqi;GONG Yabin;XU Ling(Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200437,China;Institute of Clinical Immunity, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437,China;Tumor Disease Project Team, Evidence-Based Medicine Center of China Traditional Chinese Medicine, Shanghai 200437,China)

机构地区：[1]上海中医药大学附属岳阳中西医结合医院,上海200437 [2]上海中医药大学附属岳阳中西医结合医院临床免疫研究所,上海200437 [3]中国中医药循证医学中心肿瘤疾病项目组,上海200437

出　　处：《现代中西医结合杂志》2022年第7期877-881,1004,共6页Modern Journal of Integrated Traditional Chinese and Western Medicine

基　　金：国家中医药管理局中医药循证能力建设项目(2019XZZX-ZL004);上海申康医院发展中心促进市级医院临床技能与临床创新能力三年行动计划项目(SHDC2020CR1052B);上海市科委“科技创新行动计划”医学创新研究专项(20Y21902000)。

摘　　要：目的观察益气养阴解毒方联合埃克替尼治疗老年晚期表皮生长因子受体酪氨酸激酶(EGFR)突变肺腺癌患者的疗效。方法选择2015年1月—2016年8月上海中医药大学附属龙华医院及上海中医药大学附属岳阳中西医结合医院收治的老年晚期EGFR突变肺腺癌一线或二线治疗患者69例,采用随机、双盲、安慰剂对照的前瞻性研究方法将患者分为2组,试验组39例给予益气养阴解毒方颗粒剂联合埃克替尼治疗,对照组30例予中药安慰剂颗粒联合埃克替尼治疗,2组均治疗至疾病进展或药物不可耐受。治疗1个月后,观察比较2组的客观疗效、中医症状评分及中医症状疗效、体力状况评分、生活质量FACT-L评分;随访至2020年7月20日,比较2组无进展生存期(PFS);记录治疗过程中2组不良反应发生情况。结果治疗1个月后,试验组客观缓解率为45.9%(17/37),对照组为20.7%(6/29),试验组显著高于对照组(P<0.05)。试验组中医症状评分明显低于治疗前(P<0.05),对照组降低不明显(P>0.05);试验组中医症状总有效率为47.1%(16/34),对照组为33.3%(10/30),2组比较差异无统计学意义(P>0.05);2组治疗后体力状况评分、FACT-L各项评分比较差异均无统计学意义(P均>0.05)。试验组中位PFS较对照组延长1.73个月,但2组间比较差异无统计学意义(P>0.05)。2组均未出现严重药物不良反应,且试验组皮疹、皮肤瘙痒及腹泻发生率均明显低于对照组(P均<0.05)。结论益气养阴解毒方可提高埃克替尼治疗老年晚期EGFR突变肺腺癌患者的疾病控制效果,并可减轻患者的不良反应。Objective It is to observe the clinical efficacy of Yiqi Yangyin Jiedu Decoction combined with icotinib in the treatment of elderly patients with advanced epidermal growth factor receptor(EGFR)mutant lung adenocarcinoma.Methods A total of 69 elderly patients with advanced EGFR-mutant lung adenocarcinoma who were admitted to the Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine and Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from January 2015 to August 2016 treated with first-line or second-line therapy were selected,and were divided into 2 groups by a placebo-controlled prospective research method,39 patients in the experimental group were treated with Yiqi Yangyin Jiedu Decoction granules combined with icotinib,and 30 patients in the control group were treated with traditional Chinese medicine placebo granules combined with icotinib,both groups were treated until disease progression or drug intolerance.After 1 month of treatment,the objective curative effect,TCM symptom score,TCM symptom curative effect,physical status score,and FACT-L score of life quality of the two groups were observed and compared;the follow-up was carried out until July 20,2020,and the progression-free survival time(PFS)of the two groups was compared;the occurrence of adverse reactions in the two groups during the treatment was recorded.Results After 1 month of treatment,the objective remission rate was 45.9%(17/37)in the experimental group and 20.7%(6/29)in the control group,and the experimental group was significantly higher than the control group(P<0.05).The TCM symptom score in the experimental group was significantly lower than that before treatment(P<0.05),but the decrease of the scores in the control group was not significant(P>0.05).The total effective rate of TCM symptoms in the experimental group was 47.1%(16/34)and that in the control group was 33.3%(10/30),the experimental group was significantly higher

关 键 词：益气养阴解毒方 埃克替尼 老年人 肺腺癌 表皮生长因子受体酪氨酸激酶 

分 类 号：R734.2[医药卫生—肿瘤]