中医综合治疗方案维持治疗晚期非小细胞肺癌的多中心、大样本、前瞻性队列研究  

Comprehensive Traditional Chinese Medicine Therapeutic Scheme in Maintenance Treatment for Advanced Non-small Cell Lung Cancer: a Multicenter, Large-sample and Prospective Cohort Study

作　　者：王学谦[1] 侯炜[1] 郑佳彬 林丽珠[2] 张洪亮 解英[4] 蒋益兰[5] 李平[6] 王沈玉[7] 舒琦瑾[8] 王维[9] 李建柱 李戈[11] 张美英[1] 林洪生[1] WANG Xueqian;HOU Wei;ZHENG Jiabin;LIN Lizhu;ZHANG Hongliang;XIE Ying;JIANG Yilan;LI Ping;WANG Shenyu;SHU Qijin;WANG Wei;LI Jianzhu;LI Ge;ZHANG Meiying;LIN Hongsheng(Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing,100053;The First Affiliated Hospital of Guangzhou University of Chinese Medicine;Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine;Shanxi Provincial Cancer Hospital;Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine;Anhui Provincial Hospital;Liaoning Cancer Hospital and Institute;Zhejiang Provincial Hospital of Chinese Medicine;Chongqing Cancer Hospital;Qinhuangdao Fourth Hospital;Dalian Hospital of Traditional Chinese Medicine)

机构地区：[1]中国中医科学院广安门医院,北京市100053 [2]广州中医药大学第一附属医院 [3]新疆维吾尔自治区中医院 [4]山西省肿瘤医院 [5]湖南省中医药研究院附属医院 [6]安徽省立医院 [7]辽宁省肿瘤医院 [8]浙江省中医院 [9]重庆市肿瘤医院 [10]秦皇岛市第四医院 [11]大连市中医院

出　　处：《中医杂志》2020年第8期690-694,共5页Journal of Traditional Chinese Medicine

基　　金：中医药行业科研专项(201307006);中国中医科学院中央级公益性科研院所基本科研业务费(ZZ13-024-6)。

摘　　要：目的探讨中医综合治疗方案维持治疗晚期非小细胞肺癌的临床疗效及安全性。方法采用多中心、大样本、前瞻性队列研究方法,纳入化疗2~4个周期后疗效评价疾病稳定以上进入维持阶段患者,根据患者意愿分为治疗组126例、对照组123例。对照组给予化疗药物进行维持治疗,治疗组进行中医综合治疗方案(汤药、中药注射液、中成药)维持治疗。21~28天为1个疗程,两组干预至少2个疗程。比较两组疾病无进展生存时间(PFS)、中位生存期(OS)、生活质量,同时进行药物安全性评价。结果 229例患者出现PFS终点事件(91.97%),其中治疗组114例,中位PFS为152天;对照组115例,中位PFS为161天,两组PFS比较差异无统计学意义(P>0.05)。两组共134患者死亡,其中治疗组62例,中位OS为593天;对照组72例,中位OS为518天,两组OS比较差异无统计学意义(P>0.05)。治疗组治疗后各时间点生活质量评分均较治疗前升高(P<0.05),且较同时间对照组生活质量评分均升高(P<0.01)。治疗期间两组共有45例患者出现不良事件,其中对照组33例,出现44次不良事件;治疗组12例,出现12次不良事件,治疗组不良事件发生率低于对照组(P<0.05)。结论在延长生存时间方面,中医综合治疗方案维持治疗晚期非小细胞肺癌的疗效与现代医学化疗维持作用相当,且中医综合治疗方案具有高生活质量、低不良反应的优势。Objective To explore clinical efficacy and safety of comprehensive traditional Chinese medicine(TCM) therapeutic scheme in maintenance treatment for advanced non-small cell lung cancer(NSCLC). Methods A multicenter, large-sample, prospective cohort study was conducted. After 2-4 cycles of chemotherapy, patients entering the maintenance stage with efficacy evaluation of stable disease(SD) and above were enrolled into two groups according to their intention, including 126 cases in treatment group and 123 cases in control group. The maintenance treatment in the control group was given chemotherapy drugs. The maintenance treatment of comprehensive TCM therapeutic scheme including decoctions, injections of Chinese materia medica and Chinese patent medicine was performed to the treatment group. One course of treatment was 21-28 days, and groups received the intervention for no less than 2 courses of treatment. Disease progression-free survival(PFS), median overall survival(OS) and quality of life were compared between groups, and drug safety was evaluated at the same time. Results PFS outcome events occurred in 229 patients(91.97%), with 114 cases in the treatment group(median PFS 152 days) and 115 cases in the control group(median PFS 161 days). There was no statistically significant difference in PFS between groups(P>0.05). There were 134 patients dead in the two groups, with 62 cases in the treatment group(median OS 593 days) and 72 cases in the control group(median OS 518 days). There was no statistically significant difference in OS between groups(P>0.05). The quality of life scores at each point-in-time in the treatment group were improved after the treatment(P<0.05), and they were higher than those at the same point-in-time in the control group(P<0.01). Adverse reactions occurred in 45 patients in the 2 groups during the treatment, with 33 patients in the control group(44 adverse events) and 12 patients in the treatment group(12 adverse events). The incidence of adverse events in the treatment group was lower th

关 键 词：非小细胞肺癌 中医综合治疗 维持治疗 队列研究 生存时间 中位总生存期 生活质量 

分 类 号：R734.2[医药卫生—肿瘤]