定量与定性便隐血检测用于结直肠癌组织性筛查的效果比较

Comparison of Quantitative and Qualitative Fecal Immunochemical Testing in Organized Screening for Colo-rectal Cancer

[目的]比较定量与定性便隐血检测在人群结直肠癌组织性筛查项目中的应用效果。[方法]以2021—2023年浙江省海宁市结直肠癌筛查项目中40~74岁人群为研究对象,采用整群抽样分定量免疫化学法粪便隐血试验(FIT)(免疫比浊法)组和定性FIT(胶体金法)组,比较两组人群的初筛阳性率、结肠镜检查依从率、结肠镜进展期肿瘤检出率、结肠镜负荷及成本效果。[结果]共有92093名40~74岁筛查对象完成结直肠癌初筛,其中定量FIT组44635名,平均年龄59.17岁,定性FIT组47458名,平均年龄58.91岁。定量FIT组粪便隐血阳性率4.77%(2127人)低于定性FIT组阳性率21.82%(10357人)。定量FIT组结肠镜检查依从率为53.22%,高于定性FIT组的46.55%。定量FIT组和定性FIT组对结肠镜进展期腺瘤的检出率分别为26.94%和8.73%,定量FIT组的结直肠癌和进展期腺瘤检出率均高于定性FIT组(P<0.001)。男性进展期腺瘤检出率为17.10%,高于女性的9.02%;65~74岁年龄组进展期腺瘤检出率为16.68%,高于50~64岁年龄组的12.04%和40~49岁年龄组的8.52%。定量FIT组与定性FIT组平均每发现1例早期病例成本分别为3709.08元和5551.26元,对应的早期发现成本系数分别为0.03和0.05。[结论]定量FIT技术筛查效果优于定性FIT,定量FIT技术筛查成本低于定性FIT法,定量FIT技术值得推广应用。

[Purpose]To compare the efficacy of quantitative and qualitative fecal occult blood testing in a population-based colorectal cancer screening program.[Methods]Residents aged 40~74 years old in Haining City of Zhejiang Province underwent colorectal screening from 2021 to 2023,and the whole cohort sampling was divided into quantitative fecal immunochemical test(FIT)(immunoturbidimetric assay)and qualitative FIT(colloidal gold assay)groups.The initial screening positive rate,colonoscopy adherence rate,progressed colorectal tumor detection rate,colonoscopy load,and the cost-effectiveness between the two groups were compared.[Results]A total of 92093 residents aged 40~74 years old underwent colorectal screening,among whom 44635 subjects(mean age:59.17)in quantitative FIT group and 47458 subjects(mean age:58.91)in qualitative FIT group.The positive rate in the quantitative FIT group was 4.77%(2127),which was lower than that in the qualitative FIT group(21.82%)(10357).The colonoscopy compliance rate was 53.22% in the quantitative FIT group,which was higher than that in the qualitative FIT group(46.55%).The detection rates of colonoscopy for progressive adenoma were 26.94% and 8.73% in the quantitative FIT and qualitative FIT groups,respectively,and the detection rates of colorectal cancer and progressive adenomas were higher in the quantitative FIT group than those in the qualitative FIT group(P<0.001).The detection rate of progressive adenomas was 17.10% in men,which was higher than that in women(9.02%).The detection rate of progressive adenomas was 16.68% in the age group of 65~74 years old,which was higher than those in the age group of 50~64 and 40~49 years old(12.04% and 8.52%).The average cost per early case detected in the quantitative FIT group and qualitative FIT group was RMB 3709.08 and RMB 5551.26;and the corresponding cost coefficients were 0.03 and 0.05,respectively.[Conclusion]The screening effect of quantitative FIT is better than that of qualitative FIT,the screening cost of quantitative FIT is lower than that of qualitative FIT method,indicating that the quantitative FIT is worth promoting its application in colorectal cancer screening.