结肠镜、免疫法粪便潜血检测及风险分级筛查策略在结直肠癌筛查中的效果研究:一项多中心随机对照试验  

Evaluation of the Effectiveness of Colonoscopy,Fecal Immunochemical Test and Risk-adapted Screening Strategies in Population-based Colorectal Cancer Screening:A Multicenter Randomized Controlled Trial

作　　者：陈宏达 廖先珍[2] 杜灵彬 董栋[4] 魏东华[5] 高屹[6] 郑卫方 陈静君 卢明 张愉涵 陆斌 骆晨雨 李娜 周月阳 骆家辉 蔡洁 石菊芳[10] 代敏 CHEN Hongda;LIAO Xianzhen;DU Lingbin;DONG Dong;WEI Donghua;GAO Yi;ZHENG Weifang;CHEN Jingjun;LU Ming;ZHANG Yuhan;LU Bin;LUO Chenyu;LI Na;ZHOU Yueyang;LUO Jiahui;CAI Jie;SHI Jufang;DAI Min(Medical Research Center,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China;Department of Cancer Prevention,Hunan Cancer Hospital,Changsha 410000,China;Department of Cancer Prevention,Institute of Cancer and Basic Medicine,Chinese Academy of Sciences,Cancer Hospital of University of Chinese Academy of Sciences,Zhejiang Cancer Hospital,Hangzhou 310022,China;Office of Cancer Prevention and Treatment,Xuzhou Cancer Hospital,Xuzhou,Jiangsu 221000,China;Department of Cancer Prevention,Anhui Provincial Cancer Hospital,Hefei 230031,China;Department of Colorectum Surgery,Tumor Hospital of Yunnan Province/Third Affiliated Hospital of Kunming Medical University,Kunming 650118,China;Department of Anorectal Diseases,Lanxi Hospital of Traditional Chinese Medicine,Lanxi,Zhejiang 321100,China;Department of Cancer Screening,Taizhou Cancer Hospital,Taizhou,Zhejiang 317500,China;Department of General Surgery,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China;Office of Cancer Screening,National Cancer Center,National Clinical Research Center for Cancer,Cancer Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100021,China)

机构地区：[1]中国医学科学院北京协和医院医学科学研究中心,北京100730 [2]湖南省肿瘤医院肿瘤防治研究办公室,长沙410000 [3]中国科学院大学附属肿瘤医院(浙江省肿瘤医院)防治科、中国科学院基础医学与肿瘤研究所,杭州310022 [4]徐州市肿瘤医院肿瘤防治办公室,江苏徐州221000 [5]安徽省肿瘤医院防癌科,合肥230031 [6]云南省肿瘤医院结直肠外科,昆明650118 [7]兰溪市中医院肛肠科,浙江兰溪321100 [8]台州市肿瘤医院癌症筛查中心,浙江台州317500 [9]中国医学科学院北京协和医院基本外科,北京100730 [10]国家癌症中心国家肿瘤临床医学研究中心、中国医学科学院肿瘤医院癌症早诊早治办公室,北京100021

出　　处：《协和医学杂志》2023年第1期114-123,共10页Medical Journal of Peking Union Medical College Hospital

基　　金：国家自然科学基金(82173606,82273726);北京市科技新星计划(Z191100001119065);北京市自然科学基金(7202169);中国医学科学院医学与健康科技创新工程(2017-I2M-1-006,2022-I2M-1-003)。

摘　　要：目的评价结肠镜、免疫法粪便潜血检测(fecal immunochemical test,FIT)及风险分级筛查策略在人群结直肠癌筛查中的可行性和有效性。方法基于2018年5月—2021年5月全国6个中心开展的人群结直肠癌筛查随机对照试验(TARGET-C研究),将符合要求的受试者按照1∶2∶2的比例随机分配至结肠镜组、FIT组、分级筛查组(经风险评估,高风险人群接受结肠镜检查;低风险人群接受FIT检测,FIT阳性者接受结肠镜检查)。3组人群分别接受不同方案的结直肠癌筛查,其中结肠镜组仅接受基线筛查,FIT组与分级筛查组在基线筛查的基础上接受每年1次的随访筛查。主要研究结局为进展期肿瘤(包括结直肠癌和进展期腺瘤)检出率。比较3种筛查方案的人群参与率、进展期肿瘤检出率和结肠镜检查负荷。结果共入选符合纳入与排除标准的受试者19373名,包括男性8082名(41.7%),女性11291名(58.3%);平均年龄(60.5±6.5)岁。其中结肠镜组3883名、FIT组7793名、分级筛查组7697名。FIT组与分级筛查组已完成2轮次随访筛查。FIT组整体人群筛查参与率最高(99.3%),分级筛查组次之(89.2%),结肠镜组最低(42.3%)。意向性分析结果显示,结肠镜组进展期肿瘤检出率高于FIT组(2.76%比2.17%,OR结肠镜组比FIT组=1.30,95%CI:1.01~1.65,P=0.037),结肠镜组与分级筛查组进展期肿瘤检出率无统计学差异(2.76%比2.35%,OR结肠镜组比分级筛查组=1.19,95%CI:0.93~1.51,P=0.156),分级筛查组与FIT组进展期肿瘤检出率亦无统计学差异(2.35%比2.17%,OR分级筛查组比FIT组=1.09,95%CI:0.88~1.34,P=0.440)。以每检出1例进展期肿瘤所需要的结肠镜检查次数作为评价人群筛查时结肠镜检查负荷的指标,结肠镜组的结肠镜检查负荷最高(15.4次),分级筛查组次之(10.2次),FIT组最低(7.8次)。结论基于结直肠癌风险评估的分级筛查策略对于人群结直肠癌的筛查具有可行性和有效性,可作为传统结�Objective To evaluate the feasibility and effectiveness of colonoscopy,fecal immunochemical test(FIT)and risk-adapted screening strategies in population-based colorectal cancer screening.Methods Based on the randomized controlled trial of colorectal cancer screening(TARGET-C)which was carried out in 6 centers of 5 provinces in China from May 2018 to May 2021,the participants who met the inclusion criteria of the study were randomly assigned to one of the following screening intervention groups in a ratio of 1∶2∶2,which were colonoscopy group,FIT group and risk-adapted screening group(participants evaluated to be at high risk were recommended to undertake colonoscopy,those at low risk were recommended to undertake FIT and FIT positive people received colonoscopy).The 3 groups received different schemes of colorectal cancer screening,in which the colonoscopy group only received baseline screening,whereas the FIT group and the risk-adapted screening group received annual follow-up screening on the basis of baseline screening.The main outcome was the detection rate for advanced colorectal neoplasm(including colorectal cancer and advanced adenoma).The participation rate,detection rate for any neoplasm and resource load of colonoscopy among different screening groups were further analyzed.Results A total of 19373 participants meeting the inclusion and exclusion criteria were enrolled,including 8082 males(41.7%)and 11291 females(58.3%),with an average age of(60.5±6.5)years.Among them,3883 were in the colonoscopy group,7793 in the FIT group,and 7697 in the risk-adapted screening group.After 1 or 3 rounds of screening(2 rounds of follow-up screening completed in FIT group and risk-adapted screening group),the overall participation was the highest for the FIT group(99.3%),followed by the risk-adapted screening group(89.2%)and the coloscopy group(42.3%).According to the intention-to-treat analysis,the detection rates of advanced neoplasm in the colonoscopy group was higher than that in the FIT group(2.76%vs.2.17%,ORcol

关 键 词：结直肠肿瘤 免疫法粪便潜血检测 结肠镜 分级筛查 风险评估 

分 类 号：R1[医药卫生—公共卫生与预防医学] R73