张 娟,钱立庭,魏东华.不同筛查方案结直肠癌筛查随机对照试验基线结果分析[J].中国肿瘤,2021,30(11):806-812.
不同筛查方案结直肠癌筛查随机对照试验基线结果分析
Baseline Analysis on Randomized Controlled Trial of Different Protocols in Colorectal Cancer Screening
中文关键词  修订日期:2021-07-07
DOI:10.11735/j.issn.1004-0242.2021.11.A002
中文关键词:  结直肠癌  筛查  早诊早治  结肠镜检查  安徽
英文关键词:colorectal cancer  screening  early diagnosis and treatment  colonoscopy  Anhui
基金项目:中国医学科学院医学与健康科技创新工程重大协同创新项目(2017?鄄I2M?鄄1?鄄006);国家自然科学基金青年项目(71804002)
作者单位
张 娟 安徽省肿瘤医院 
钱立庭 安徽省肿瘤医院 
魏东华 安徽省肿瘤医院 
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中文摘要:
      摘 要:[目的] 分析结肠镜、粪便隐血试验(FIT)及风险评估筛查方案的人群结直肠癌筛查参与率和筛查效果。[方法] 2018年5月至2019年5月,在安徽省合肥市招募50~74岁且符合研究要求的受试者,将其随机分配到3个筛查组(按1∶2∶2的比例):结肠镜组、FIT组、风险评估组。所有受试者进行风险调查和评估,结肠镜组进行结肠镜检查,FIT组进行FIT检测,阳性者行结肠镜检查,风险评估组评估为高危者进行结肠镜检查,低危者进行FIT检测。计算不同筛查方案的参与率、检出率和阳性预测值。[结果] 共计招募3 821名受试者,结肠镜组、FIT组、风险评估组的参与率分别是45.3%(347/766)、96.0%(1 470/1 532)、86.0%(1 310/1 523);结肠镜检查参与率分析显示,FIT组阳性人群参与率最高为80.6%,结肠镜组最低为45.3%,差异有统计学意义(P<0.05);三组筛查方法在进展期肿瘤检出率方面,差异无统计学意义(P>0.05)。FIT组阳性对于进展期腺瘤阳性预测值最高(P<0.05)。在筛查中所需结肠镜检查负荷指标上,每检出1例进展期肿瘤所需要的结肠镜检查数,结肠镜组为20例,FIT组为10例,风险评估组为19例。[结论] FIT组及风险评估组显示出较高的参与率,在人群筛查中所需结肠镜检查的负荷数量方面,FIT法展示了较好的筛查效率。
英文摘要:
      Abstract:[Purpose] To analyze the performance of protocols of colonoscopy,fecal immunochemical test(FIT) and risk assessment in colorectal cancer screening. [Methods] From May 2018 to May 2019,eligible participants aged 50~74 years in Anhui Province were recruited and randomly allocated into colonoscopy group,FIT group and risk assessment screening group for screening of colorectal cancer with a ratio of 1∶2∶2. Colonoscopy group was directly subjected to colonoscopy; FIT group was subjected to FIT test,for those with positive result subjected to colonoscopy; and risk assessment group was subjected to risk assessment,in which colonoscopy was performed for those with high-risk and FIT test was given for those with low-risk. Participation rate,detection rate and positive predictive value in all three groups were calculated. [Results] A total of 3 821 subjects were recruited. The participation rates of the colonoscopy,FIT and risk assessment screening groups were 45.3%(347/766),96.0%(1 470/1 532) and 86.0%(1 310/1 523),respectively. The compliance rate of colonoscopy was 80.6% in the FIT positive subjects,which was significantly higher than that in colonoscopy group(45.3%,P<0.05). There was no significant difference in the detection rate of advanced tumor among three groups(P>0.05). The positive predictive value for advanced adenoma in FIT positive group was the highest(P<0.05).The number needed for colonoscopy to detect one advanced tumor were 20,10 and 19 cases for three groups,respectively. [Conclusion] The FIT and risk assessment screening approaches show high participation rates. In terms of the number needed for colonoscopy to detect one advanced tumor,FIT method showed better screening effect.
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