定量粪便免疫化学试验在结直肠癌伺机性筛查中的应用分析

Application analysis of quantitative fecal immunochemical test in opportunistic screening of colorectal cancer

目的分析和评价定量粪便免疫化学试验(FIT)在无症状健康体检人群结直肠癌伺机性筛查中的应用情况。方法选择2018年1月1日至2021年12月31日在苏州大学附属第一医院健康管理中心进行常规体检并行定量FIT结直肠癌伺机性筛查的53319例体检者,其中定量FIT阳性并完成结肠镜检查者纳入定量FIT阳性组,定量FIT阴性并完成结肠镜检查者纳入定量FIT阴性组。分析定量FIT参与率、阳性率。以结肠镜和病理检查结果为金标准,包括无明显异常,非息肉性病变,息肉样病变[增生性和(或)炎症性息肉、非进展期腺瘤、进展期腺瘤],以及结直肠癌,分析定量FIT阳性与阴性组的各类病变检出率,受检者的定量FIT测定值,以及定量FIT对结直肠癌和进展期腺瘤的灵敏度和阴性预测值。绘制受试者操作特征曲线(ROC)并计算曲线下面积(AUC),评估定量FIT对结直肠癌和进展期腺瘤的筛查效能。统计学方法采用卡方检验或Fisher确切概率法、Wilcoxon秩和检验。结果共完成定量FIT检测51420例,总参与率为96.44%(51420/53319),定量FIT阳性2483例(4.83%)。定量FIT阳性人群结肠镜参与率为26.22%(651/2483),其中540例被纳入定量FIT阳性组;定量FIT阴性人群结肠镜参与率为1.18%(576/48937),其中523例被纳入定量FIT阴性组。定量FIT阳性组的结直肠癌、进展期腺瘤检出率均高于定量FIT阴性组[3.9%(21/540)比0(0/523)、16.1%(87/540)比3.3%(17/523)],差异均有统计学意义(Fisher确切概率法、χ^(2)=49.79,均P<0.001)。定量FIT测定值从高到低依次为结直肠癌、进展期腺瘤、非息肉性病变、非进展期腺瘤、无明显异常、增生性和(或)炎症性息肉[分别为1052.0 ng/mL(390.5 ng/mL,3058.0 ng/mL)、294.5 ng/mL(116.8 ng/mL,951.8 ng/mL)、131.5 ng/mL(10.5 ng/mL,327.3 ng/mL)、97.0 ng/mL(11.0 ng/mL,238.0 ng/mL)、20.0 ng/mL(0.0 ng/mL,175.3 ng/mL)、14.0 ng/mL(0.0 ng/mL,171.0 ng/mL)],差异有统计学意义(H=120.53,P<0.001)。定量FIT对结直肠癌和进展期腺瘤的灵敏度[95%置信区间(95%CI)]分别为100.0%(80.8%~100.0%)和83.6%(74.8%~89.9%),阴性预测值(95%CI)分别为100.0%(99.1%~100.0%)和96.7%(94.7%~98.0%)。ROC分析显示,定量FIT筛查结直肠癌和进展期腺瘤的AUC(95%CI)分别为0.874(0.820~0.928)和0.723(0.675~0.770)。结论本研究定量FIT参与率高,定量FIT阳性的高危人群中有更多的结直肠癌和进展期腺瘤患者,且定量FIT对结直肠癌和进展期腺瘤具有良好的灵敏度和阴性预测值。因此,对于健康体检人群结直肠癌筛查应提倡定量FIT阳性-结肠镜序贯筛查,该方法也可能适用于我国大规模人群的结直肠癌筛查。

Objective To analyze and evaluate the application of quantitative fecal immunochemical test(FIT)in opportunistic screening of colorectal cancer in asymptomatic population undergoing health checkups.Methods From January 1,2018 to December 31,2021,at the Health Management Center of the First Affiliated Hospital of Soochow University,53319 subjects who underwent routine health checkups and with quantitative FIT opportunistic screening for colorectal cancer were selected.Those with positive quantitative FIT results and received colonoscopy were enrolled in the FIT positive group,and those with negative quantitative FIT results and received colonoscopy were enrolled in the FIT negative group.The participation rate and positive rate of quantitative FIT were analyzed.The results of colonoscopy and pathological findings were taken as the gold standard,including normal,non-polyposis lesions,polyposis(hyperplastic and(or)inflammatory polyps,non-advanced adenoma,advanced adenoma),and colorectal cancer,the detection rates of various lesions of the FIT positive and negative groups,the quantitative FIT measurement value of subjects,and the sensitivity and negative predictive value of quantitative FIT for colorectal cancer and advanced adenoma were analyzed.The receiver operating characteristic curve(ROC)was drawn and the area under the curve(AUC)was calculated,the screening efficacy of quantitative FIT for colorectal cancer and advanced adenoma was evaluated.Chi-square test or Fisher exact probability method and Wilcoxon rank sum test were used for statistical analysis.Results A total of 51420 cases had completed quantitative FIT,and the total participation rate was 96.44%(51420/53319).Quantitative FIT was positive in 2483 cases(4.83%).The participation rate of colonoscopy in FIT positive group was 26.22%(651/2483),of which 540 cases were enrolled in FIT positive group.The colonoscopy participation rate of FIT negative group was 1.18%(576/48937),of which 523 cases were enrolled in the FIT negative group.The detection rates of colorectal cancer and advanced adenoma in FIT positive group were both higher than those of the FIT negative group(3.9%,21/540 vs.0,0/523;16.1%,87/540 vs.3.3%,17/523),and the differences were statistically significant(Fisher exact probability method and χ^(2)=49.79;both P<0.001).Populations with quantitative FIT values from high to low were those with colorectal cancers,advanced adenomas,non-polyp lesions,non-advanced adenomas,normal,and hyperplastic and(or)inflammatory polyps(1052.0 ng/mL(390.5 ng/mL,3058.0 ng/mL);294.5 ng/mL(116.8 ng/mL,951.8 ng/mL);131.5 ng/mL(10.5 ng/mL,327.3 ng/mL);97.0 ng/mL(11.0 ng/mL,238.0 ng/mL);20.0 ng/mL(0.0 ng/mL,175.3 ng/mL);14.0 ng/mL(0.0 ng/mL,171.0 ng/mL)),and the difference was statistically significant(H=120.53,P<0.001).The sensitivities(95% confidence interval(95%CI))of quantitative FIT in colorectal cancer and advanced adenoma were 100.0%(80.8% to 100.0%)and 83.6%(74.8% to 89.9%),respectively.The negative predictive values(95%CI)were 100.0%(99.1% to 100.0%)and 96.7%(94.7% to 98.0%),respectively.The results of ROC analysis showed that the AUCs(95%CI)of quantitative FIT in colorectal cancer and advanced adenoma were 0.874(0.820 to 0.928)and 0.723(0.675 to 0.770),respectively.Conclusions In this study,the participation rate of quantitative FIT is high.More patients with advanced adenomas and colorectal cancers are found in the high risk popolation with positive quantitative FIT.Quantitative FIT has a good sensitivity and a negative predictive value for colorectal cancer and advanced adenoma.Therefore,positive quantitative FIT-colonoscopies sequential screening should be advocated in population undergoing health checkups for colorectal cancer screening,and it may be applicable to large-scale population screening in China.