复方红豆杉胶囊维持治疗气虚痰瘀证晚期非小细胞肺癌的多中心、大样本、前瞻性队列研究  

Adjuvant compound yew capsules in maintenance treatment for advanced non-small cell lung cancer with qi deficiency and phlegm stasis syndrome:A multicenter,large sample,prospective cohort study

作　　者：王学谦[1] 张英[1] 董军 王维[2] 焦智民[3] 张勇[4] 蒋益兰[5] 杨祖贻[6] 薛文翰[7] 王慧娟 都振利 王新杰[10] 李润浦 孙红梅[12] 曹晓红 张美英[1] 侯炜[1] WANG Xueqian;ZHANG Ying;DONG Jun;WANG Wei;JIAO Zhimin;ZHANG Yong;JIANG Yilan;YANG Zuyi;XUE Wenhan;WANG Huijuan;DU Zhenli;WANG Xinjie;LI Runpu;SUN Hongmei;CAO Xiaohong;ZHANG Meiying;HOU Wei(Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Chongqing Cancer Hospital,Chongqing 400030,China;Anyang Cancer Hospital,Henan Anyang 455001,China;Shanxi Provincial Cancer Hospital,Shanxi Taiyuan 030013,China;Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine,Hunan Changsha 410006,China;Sichuan Cancer Hospital,Sichuan Chengdu 610042,China;Gansu Cancer Hospital,Gansu Lanzhou 730050,China;Gansu Wuwei Tumor Hospital,Gansu Wuwei 733099,China;Dezhou Second People's Hospital,Shandong Dezhou 253007,China;The First Affiliated Hospital of Zhengzhou University,Henan Zhengzhou 450052,China;Baoding Second Central Hospital,Hebei Baoding 072750,China;Cancer Hospital of Jiamusi City,Heilongjiang Jiamusi 154007,China;Fenyang Hospital of Shanxi Province,Shanxi Lvliang 032299,China)

机构地区：[1]中国中医科学院广安门医院,北京100053 [2]重庆市肿瘤医院,重庆400030 [3]安阳市肿瘤医院,河南安阳455001 [4]山西省肿瘤医院,山西太原030013 [5]湖南省中医药研究院附属医院,湖南长沙410006 [6]四川省肿瘤医院,四川成都610042 [7]甘肃省肿瘤医院,甘肃兰州730050 [8]甘肃省武威肿瘤医院,甘肃武威733099 [9]德州市第二人民医院,山东德州253007 [10]郑州大学第一附属医院,河南郑州450052 [11]保定市第二中心医院,河北保定072750 [12]佳木斯市肿瘤医院,黑龙江佳木斯154007 [13]山西省汾阳医院,山西吕梁032299

出　　处：《现代肿瘤医学》2024年第9期1631-1637,共7页Journal of Modern Oncology

基　　金：中国中医科学院科技创新工程重大攻关项目(编号:C12021A01801);国家中医药管理局中医药创新团队及人才支持计划项目(编号:ZYYCXTD-C-202205);“优秀青年科技人才(创新类)”培养专项(编号:ZZ14-YQ-013);北京市科学技术协会-青年人才托举工程(编号:BYESS2023357)。

摘　　要：目的:探讨复方红豆杉胶囊维持治疗气虚痰瘀证晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的临床疗效和安全性。方法:采用多中心、大样本、前瞻性队列研究方法,纳入一线化疗4~6周期后疗效评价疾病稳定以上进入维持治疗阶段患者,根据患者意愿分为治疗组160例,对照组109例。对照组根据鳞癌和非鳞癌分别给予吉西他滨和培美曲塞单药化疗维持治疗,治疗组给予复方红豆杉胶囊维持治疗。均以21天为1个疗程,两组干预至少2个疗程,每周期进行生活质量评价,每2疗程进行影像学疗效评价。比较两组疾病无进展生存时间(progression-free survival time,PFS)、生活质量,同时进行药物安全性评价。结果:269例入组患者中,246例患者出现PFS终点事件(91.45%),其中治疗组145例,中位PFS为106天,对照组101例,中位PFS为120天,两组PFS比较差异无统计学意义(P>0.05)。采用美国肺癌生存质量量表(FACT-L4.0版)和欧洲五维健康量表中视觉模拟量表(EQ-5D-VAS)对两组患者生活质量评分进行比较,两种生活质量评价量表均提示治疗组较对照组在提高生活质量方面存在优势(P<0.05)。治疗期间两组共有19例患者出现ADR,治疗组7例(占治疗组人数4.38%),对照组12例(占对照组人数11.01%),ADR发生率在治疗组中更低,尤其表现在骨髓抑制不良反应的发生率方面。结论:在延长PFS方面,复方红豆杉胶囊维持治疗气虚痰瘀证晚期NSCLC的疗效非劣于现代医学单药维持化疗,且在高生活质量、低不良反应方面,复方红豆杉胶囊更具有一定优势。Objective:To investigate the clinical efficacy and safety of adjuvant compound yew capsules for maintenance treatment of advanced non-small cell lung cancer(NSCLC)with Qi deficiency and phlegm stasis syndrome.Methods:Through a multicenter,large sample,prospective cohort study,the patients with stable disease and above into maintenance treatment after 4~6 cycles of first-line chemotherapy were included.And they were divided into the treatment group(160 cases)and the control group(109 cases)according to their willingness.The control group was given single drug of gemcitabine and pemetrexed for squamous cell carcinoma and non-squamous cell carcinoma respectively,and the treatment group was given adjuvant compound yew capsules for maintenance treatment.Both groups were given 21 days as 1 course of treatment,with at least 2 courses intervened,with quality of life evaluated every cycle and imaging efficacy evaluated every 2 courses of treatment.Progression-free survival time(PFS)and quality of life were compared between the two groups,and drug safety evaluation was also performed.Results:Among the 269 enrolled patients,246 patients had PFS endpoint events(91.45%),including 145 patients in the treatment group with a median PFS of 106 days and 101 patients in the control group with a median PFS of 120 days,with no statistical significance between the two groups in PFS(P>0.05).The American lung cancer quality of life scale(FACT-L4.0)and the EuroQol five dimension scale(EQ-5D-VAS)were used to compare the scores of life quality of the two groups.Both of the two life quality assessment scales suggested that the treatment group had an advantage over the control group in improving the quality of life(P<0.05).During the treatment,a total of 19 patients in both groups developed ADR,including 7 patients in the treatment group(4.38%)and 12 patients in the control group(11.01%).The incidence of ADR was lower in the treatment group,especially manifested in adverse reactions of bone marrow suppression.Conclusion:In terms of prolongin

关 键 词：复方红豆杉胶囊 非小细胞肺癌 维持治疗 疾病无进展生存时间 生活质量 队列研究 

分 类 号：R734.2[医药卫生—肿瘤]