基于循环肿瘤细胞金复康口服液联合化疗治疗术后Ⅰb~Ⅱb期非小细胞肺癌的临床研究  

Clinical study on Jinfukang Oral Liquid combined with chemotherapy in the treatment of non-small cell lung cancer at Ⅰb-Ⅱb stages after operation based on circulating tumor cell

作　　者：陆恩昊[1] 姚逸临[1] 李和根[1] 朱丽华[1] 周蕾[1] 范瑞 欧阳怡然 张任 田合川 LU Enhao;YAO Yilin;LI Hegen;ZHU Lihua;ZHOU Lei;FAN Rui;OUYANG Yiran;ZHANG Ren;TIAN Hechuan(Department of Oncology,Longhua Hospital Affliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)

机构地区：[1]上海中医药大学附属龙华医院肿瘤科,上海200032

出　　处：《上海中医药大学学报》2022年第4期31-35,共5页Academic Journal of Shanghai University of Traditional Chinese Medicine

基　　金：上海市卫健委卫生行业临床研究专项项目(201940144);上海市卫健委临床重点专科(中医肿瘤)建设项目(shslczdzk03701);上海市科委中医肿瘤临床医学研究中心建设项目(21MC1930500)。

摘　　要：目的:基于循环肿瘤细胞(CTC)比较单纯化疗与金复康口服液联合化疗治疗Ⅰb~Ⅱb期非小细胞肺癌(NSCLC)术后患者的疗效差异。方法:采用多中心随机对照研究方法,纳入144例Ⅰb~Ⅱb期NSCLC术后患者,随机分为治疗组72例与对照组72例,对照组患者给予含铂双药化疗方案治疗,治疗组患者在对照组治疗基础上给予金复康口服液口服。21~28 d为1个化疗周期,共治疗4个周期。分别于化疗前、化疗中(第2周期化疗后)、化疗后(第4周期化疗后)及化疗结束后1年、1.5年、2年,检测所有患者的CTC计数,并于化疗前检测所有患者的肿瘤标志物及免疫指标水平。采用重复测量分析探讨CTC变化趋势,采用Spearman分析法对CTC计数与肿瘤标志物、免疫指标水平进行相关性分析,采用多因素线性回归对CTC计数与免疫指标水平进行相关性分析。结果:研究中,3例患者被剔除,最终纳入统计分析者治疗组70例、对照组71例。(1)对照组患者的CTC计数在化疗期间下降,但在化疗结束后出现反弹,治疗组患者的CTC计数在化疗中及化疗后均持续下降,无反弹趋势。(2)Ⅱb期患者化疗结束后1年CTC计数治疗组低于对照组(P<0.05),其他观察时点组间差异均无统计学意义(P>0.05)。(3)相关性分析结果显示,CTC计数与癌胚抗原(CEA)、CD8+T淋巴细胞水平呈正相关(P<0.05)。结论:金复康口服液联合化疗可在一定程度上降低Ⅰb~Ⅱb期NSCLC术后患者外周血CTC计数,并在一定程度上抑制化疗结束后CTC计数的反弹趋势,尤其对Ⅱb期患者效果更显著。Objective:To compare the curative effect between chemotherapy and Jinfukang Oral Liquid combined with chemotherapy in treating postoperative patients with non-small cell lung cancer(NSCLC)at Ⅰ b-Ⅱ b stages based on circulating tumor cell(CTC).Methods:A multi-center randomized controlled trial was applied. A total of 144 postoperative patients with NSCLC at Ⅰb-Ⅱb stages were included and randomly divided into the treatment group(72 cases)and control group(72 cases). The patients in the control group were treated with platinum-containing double-drug chemotherapy,and the patients in the treatment group were orally treated with Jinfukang Oral Liquid based on the treatment of the control group. 21~28 days were one chemotherapy cycle and a total of 4 cycles were done. Before chemotherapy,in the middle of chemotherapy(after two chemotherapy cycles),after chemotherapy(after four chemotherapy cycles),and 1,1.5 and 2 years after chemotherapy,the CTC count of all patients was detected,and the levels of tumor marker and immunological indicators were tested before chemotherapy. The changing trend of CTC was explored by repeated measurement analysis,the correlation between CTC count and the levels of tumor marker and immunological indicators was analyzed by Spearman analysis method,and the correlation between CTC count and the levels of immunological indicators was analyzed by multiple linear regression.Results:In the study,3 patients were eliminated,and finally 70 cases in the treatment group and 71 cases in the control group were included in the statistical analysis.(1)The CTC count of the control group decreased during chemotherapy,but rebounded after chemotherapy,and the CTC count of the treatment group decreased continuously in the middle of chemotherapy and after chemotherapy with no rebound trend.(2)One year after chemotherapy,the CTC count of the patients at Ⅱb stage in the treatment group was lower than that in the control group(P<0.05),and there were no statistical differences in other time points(P>0.05).(

关 键 词：非小细胞肺癌 术后 金复康口服液 化疗 循环肿瘤细胞 

分 类 号：R734.2[医药卫生—肿瘤]