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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

陈宏达,  廖先珍,  杜灵彬,  董栋,  魏东华,  高屹,  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,  代敏

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文章导航 > 协和医学杂志  > 2023 >  14(1): 114-123
陈宏达, 廖先珍, 杜灵彬, 董栋, 魏东华, 高屹, 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, 代敏. 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[J]. 协和医学杂志, 2023, 14(1): 114-123. doi: 10.12290/xhyxzz.2022-0537
引用本文: 陈宏达, 廖先珍, 杜灵彬, 董栋, 魏东华, 高屹, 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, 代敏. 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[J]. 协和医学杂志, 2023, 14(1): 114-123. doi: 10.12290/xhyxzz.2022-0537
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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. 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[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(1): 114-123. doi: 10.12290/xhyxzz.2022-0537
Citation: 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. 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[J]. Medical Journal of Peking Union Medical College Hospital, 2023, 14(1): 114-123. doi: 10.12290/xhyxzz.2022-0537
shu

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

doi: 10.12290/xhyxzz.2022-0537
  • 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

基金项目: 

国家自然科学基金 82173606

国家自然科学基金 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

中国医学科学院医学与健康科技创新工程 2022-I2M-1-003

详细信息
    通讯作者:

    代敏, E-mail：daimin2002@hotmail.com

  • 中图分类号: R1; R73

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

  • 1.

    Medical Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

  • 2.

    Department of Cancer Prevention, Hunan Cancer Hospital, Changsha 410000, China

  • 3.

    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

  • 4.

    Office of Cancer Prevention and Treatment, Xuzhou Cancer Hospital, Xuzhou, Jiangsu 221000, China

  • 5.

    Department of Cancer Prevention, Anhui Provincial Cancer Hospital, Hefei 230031, China

  • 6.

    Department of Colorectum Surgery, Tumor Hospital of Yunnan Province/ Third Affiliated Hospital of Kunming Medical University, Kunming 650118, China

  • 7.

    Department of Anorectal Diseases, Lanxi Hospital of Traditional Chinese Medicine, Lanxi, Zhejiang 321100, China

  • 8.

    Department of Cancer Screening, Taizhou Cancer Hospital, Taizhou, Zhejiang 317500, China

  • 9.

    Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

  • 10.

    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

Funds: 

National Natural Science Foundation of China 82173606

National Natural Science Foundation of China 82273726

Beijing Nova Program of Science and Technology Z191100001119065

Natural Science Foundation of Beijing Municipality 7202169

CAMS Innovation Fund for Medical Sciences 2017-I2M-1-006

CAMS Innovation Fund for Medical Sciences 2022-I2M-1-003

More Information

    摘要
  • 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19 373名，包括男性8082名(41.7%)，女性11 291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，可作为传统结肠镜检查和FIT筛查方案的有效补充。
    Abstract:   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 19 373 participants meeting the inclusion and exclusion criteria were enrolled, including 8082 males(41.7%) and 11 291 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%, ORcolonoscopy vs FIT=1.30, 95% CI: 1.01-1.65, P=0.037); there were no statistically significant differences regarding the detection rates of advanced neoplasm between the colonoscopy group and the risk-adapted screening group(2.76% vs. 2.35%, ORcolonoscopy vs risk-adapted screening=1.19, 95% CI: 0.93-1.51, P=0.156), and between the risk-adapted screening group and the FIT group(2.35% vs. 2.17%, ORrisk-adapted screening vs FIT=1.09, 95% CI: 0.88-1.34, P=0.440). The number of colonoscopies needed to be performed to detect one advanced neoplasm was used as an indicator to evaluate the resource load of colonoscopy. The number was the highest for the coloscopy group(15.4), followed by the risk-adapted screening group(10.2) and the FIT group(7.8).  Conclusions  The risk-adapted screening strategy is feasible and effective in population-based colorectal cancer screening, and could serve as an effective supplement to the traditional colonoscopy and FIT-based colorectal cancer screening strategies.
    作者贡献：陈宏达负责研究方案设计、实施和论文撰写；廖先珍、杜灵彬、董栋、魏东华、高屹、郑卫方、陈静君、石菊芳负责各中心研究实施、数据收集；卢明、张愉涵、陆斌、骆晨雨、李娜、周月阳、骆家辉、蔡洁负责数据整理与核查；代敏负责总体研究设计、论文修订；所有作者均参与论文审校。
    利益冲突：所有作者均声明不存在利益冲突
    • HTML全文

  • 图  1  研究对象入组流程图

    FIT：免疫法粪便潜血检测

    下载: 全尺寸图片 幻灯片

    图  2  3组筛查方案的人群参与率

    FIT：同图 1

    下载: 全尺寸图片 幻灯片

    表  1  19 373名受试者基线资料比较[n(%)]

    指标 结肠镜组(n=3883) FIT组(n=7793) 分级筛查组(n=7697) P值
    性别0.172 0.172
      男性 1617(41.6) 3310(42.5) 3155(41.0)
      女性 2266(58.4) 4483(57.5) 4542(59.0)
    年龄(岁) 0.545
      50~54 906(23.3) 1825(23.4) 1836(23.9)
      55~59 830(21.4) 1603(20.6) 1574(20.4)
      60~64 992(25.5) 1924(24.7) 1886(24.5)
      65~69 807(20.8) 1729(22.2) 1658(21.5)
      70~74 348(9.0) 712(9.1) 743(9.7)
    教育背景* 0.614
      初中及以下 2701(73.4) 5605(72.2) 5595(72.9)
      高中 696(18.9) 1542(19.9) 1495(19.5)
      大学及以上 281(7.6) 621(8.0) 582(7.6)
    体质量指数(kg/m2)* 0.614
      ＜23 1395(37.9) 2872(37.0) 2860(37.3)
      ≥23 2283(62.1) 4896(63.0) 4812(62.7)
    吸烟* 0.646
      非吸烟 2978(81.0) 6269(80.7) 6154(80.2)
      戒烟 572(15.6) 1217(15.7) 1212(15.8)
      吸烟 128(3.5) 282(3.6) 306(4.0)
    饮酒* 0.168
      从不 2659(72.3) 5722(73.7) 5649(73.6)
      偶尔 491(13.3) 1047(13.5) 983(12.8)
      规律 528(14.4) 999(12.9) 1040(13.6)
    一级亲属结直肠癌家族史* ＜0.001
      是 160(4.4) 335(4.3) 473(6.2)
      否 3427(93.2) 7277(93.7) 7038(91.7)
      不清楚 91(2.5) 156(2.0) 161(2.1)
    FIT：同图 1；*结肠镜组、FIT组和分级筛查组中分别有205名、25名、25名受试者信息缺失
    下载: 导出CSV

    表  2  3次筛查中FIT组与分级筛查组FIT阳性率以及结肠镜检查顺应率比较

    筛查方案 基线筛查 第1次随访筛查 第2次随访筛查
    FIT阳性率
    [%，(N阳性/N受检)]    		 结肠镜检查顺应率
    [%，(N接受/N阳性)]    		 FIT阳性率
    [%，(N阳性/N受检)]    		 结肠镜检查顺应率
    [%，(N接受/N阳性)]    		 FIT阳性率
    [%，(N阳性/N受检)]    		 结肠镜检查顺应率
    [%，(N接受/N阳性)]
    FIT组 13.7(1071/7793) 76.3(817/1071) 5.6(341/6048) 75.7(258/341) 5.5(339/6113) 71.7(243/339)
    分级筛查组(低风险人群) 10.2(782/7697) 76.9(601/782) 3.8(244/6352) 74.6(182/244) 2.7(163/6131) 60.1(98/163)
    FIT: 同图 1
    下载: 导出CSV

    表  3  结肠镜组、FIT组和分级筛查组3次筛查中进展期肿瘤检出率比较

    筛查阶段 进展期肿瘤(%，95% CI) 结肠镜组比FIT组
    结肠镜组 FIT组 分级筛查组 OR(95% CI)† P值
    基线筛查
      总体 2.76(2.29~3.32) 1.15(0.94~1.42) 1.65(1.39~1.96) 2.45(1.84~3.26) ＜0.001
        近端结肠* 1.36(1.05~1.78) 0.53(0.39~0.71) 0.62(0.47~0.83) 2.62(1.74~3.97) ＜0.001
        远端结肠和直肠# 1.73(1.36~2.19) 0.80(0.62~1.02) 1.17(0.95~1.43) 2.19(1.54~3.12) ＜0.001
        基线筛查+第1次随访筛查
      总体 2.76(2.29~3.32) 1.67(1.41~1.98) 1.91(1.63~2.24) 1.68(1.29~2.18) ＜0.001
        近端结肠* 1.36(1.05~1.78) 0.72(0.55~0.93) 0.73(0.56~0.94) 1.91(1.30~2.79) 0.001
        远端结肠和直肠# 1.73(1.36~2.19) 1.15(0.94~1.42) 1.35(1.12~1.63) 1.50(1.08~2.06) 0.014
    基线筛查+第1次随访筛查+第2次随访筛查
      总体 2.76(2.29~3.32) 2.17(1.87~2.52) 2.35(2.04~2.71) 1.30(1.01~1.65) 0.037
        近端结肠* 1.36(1.05~1.78) 0.96(0.77~1.20) 0.90(0.71~1.13) 1.46(1.03~2.05) 0.031
        远端结肠和直肠# 1.73(1.36~2.19) 1.48(1.23~1.77) 1.65(1.39~1.96) 1.19(0.88~1.61) 0.244
    筛查阶段 结肠镜组比分级筛查组 分级筛查组比FIT组
    OR(95% CI)† P值 OR(95% CI)† P值
    基线筛查
      总体 1.69(1.29~2.20) ＜0.001 1.45(1.11~1.92) 0.008
        近端结肠* 2.21(1.49~3.28) ＜0.001 1.19(0.79~1.82) 0.409
        远端结肠和直肠# 1.46(1.06~2.02) 0.021 1.49(1.08~2.08) 0.017
    基线筛查+第1次随访筛查
      总体 1.45(1.12~1.87) 0.004 1.15(0.91~1.47) 0.245
        近端结肠* 1.89(1.29~2.76) 0.001 1.01(0.70~1.47) 0.941
        远端结肠和直肠# 1.26(0.92~1.72) 0.148 1.18(0.88~1.57) 0.266
    基线筛查+第1次随访筛查+第2次随访筛查
      总体 1.19(0.93~1.51) 0.156 1.09(0.88~1.34) 0.440
        近端结肠* 1.56(1.10~2.20) 0.012 0.94(0.68~1.29) 0.681
        远端结肠和直肠# 1.06(0.79~1.42) 0.680 1.12(0.87~1.44) 0.384
    FIT：同图 1；*包括病变检出部位仅为近端结肠或近端与远端结肠/直肠同时存在的病例；#包括病变检出部位仅为远端结肠/直肠或近端与远端结肠/直肠同时存在的病例；†Logistics回归分析校正年龄、性别和研究中心后，各筛查方案对进展期肿瘤检出风险的OR值和95% CI
    下载: 导出CSV

    表  4  结肠镜组、FIT组和分级筛查组3次筛查中结肠镜检查负荷比较

    筛查阶段 进展期肿瘤(n, 95% CI) 任意结直肠肿瘤(n, 95% CI)
    结肠镜组 FIT组 分级筛查组 结肠镜组 FIT组 分级筛查组
    基线筛查
      总体 15.4(12.8~18.5) 9.1(7.5~11.1) 10.3(8.8~12.2) 4.1(3.8~4.5) 3.2(2.9~3.5) 3.5(3.2~3.8)
        男性 10.7(8.5~13.5) 6.5(5.2~8.3) 8.0(6.7~9.5) 3.0(2.7~3.4) 2.5(2.2~2.8) 2.8(2.6~3.1)
        女性 22.9(17.0~30.9) 14.7(10.4~21.1) 22.4(14.9~34.0) 5.6(4.9~6.4) 4.5(3.8~5.4) 5.9(4.9~7.3)
    基线筛查+第1次随访筛查
      总体 15.4(12.8~18.5) 8.3(7.1~9.7) 10.5(9.0~12.2) 4.1(3.8~4.5) 3.1(2.9~3.4) 3.4(3.2~3.7)
        男性 10.7(8.5~13.5) 6.2(5.1~7.5) 8.2(6.9~9.8) 3.0(2.7~3.4) 2.5(2.3~2.8) 2.9(2.6~3.1)
        女性 22.9(17.0~30.9) 12.5(9.4~16.7) 18.6(13.4~26.1) 5.6(4.9~6.4) 4.2(3.6~4.9) 5.1(4.3~6.0)
    基线筛查+第1次随访筛查+第2次随访筛查
      总体 15.4(12.8~18.5) 7.8(6.8~9.0) 10.2(8.9~11.8) 4.1(3.8~4.5) 3.0(2.8~3.3) 3.5(3.2~3.7)
        男性 10.7(8.5~13.5) 5.9(5.0~7.0) 8.3(7.1~9.8) 3.0(2.7~3.4) 2.5(2.3~2.7) 2.9(2.7~3.1)
        女性 22.9(17.0~30.9) 11.4(8.9~14.5) 15.3(11.8~20.1) 5.6(4.9~6.4) 3.9(3.5~4.5) 4.9(4.3~5.6)
    FIT: 同图 1
    下载: 导出CSV
    • 参考文献(23)
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  • 收稿日期:  2022-09-26
  • 录用日期:  2022-11-22
  • 刊出日期:  2023-01-30

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