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

[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3821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%(1470/1532)、86.0%(1310/1523);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。

[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 3821 subjects were recruited.The participation rates of the colonoscopy,FIT and risk assessment screening groups were 45.3%(347/766),96.0%(1470/1532)and 86.0%(1310/1523),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.