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目的 探讨定量与定性粪隐血试剂在结直肠癌筛查中的应用效果.方法 以结直肠癌早诊早治筛查为平台,不改变原有筛查方法和流程,抽取浙江省海宁市的4个村40～74岁结直肠癌筛查应检人员为研究对象,初筛包括病史问卷和粪隐血试验,首次粪便采样分别用定量与定性试剂检测,间隔1周后第2次采样用粪隐血定性检测.病史问卷阳性或任意试剂出现1次阳性即为初筛阳性;初筛阳性者进行精筛(电子结肠镜检查).效果评价包括粪隐血阳性率、肠道病变检出率、试剂敏感度、特异度、约登指数等,并进行卫生经济学分析.组间率的比较采用卡方检验.结果 4个村共完成8 427份病史问卷调查,阳性715例(8.48％);粪隐血定量试剂检测6 644份,阳性295例(4.44％);定性试剂检测12 633份,324例阳性(2.56％),定量检测与定性检测比较,差异有统计学意义(x2=49.27,P＜0.01).共有854例初筛阳性者行电子结肠镜检查,总体肠道病变检出率为22.72％(194/854);其中定量组病变检出率为34.55％(66/191),定性组为17.73％(36/203),两组比较差异有统计学意义(x2=14.53,P＜0.01),定量与定性双阳性者中病变检出率为43.75％(14/32).定量与定性粪隐血试剂结直肠癌检出率分别为3.66％(7/191)和0.99％(2/203);进展期腺瘤检出率分别为8.38％(16/191)和5.91％(12/203),但差异均无统计学意义(x2=2.08和0.96,P均＞0.05);定量和定性粪隐血诊断进展期腺瘤以上病变(癌)的敏感度分别为45.10％和27.45％;定量与定性粪隐血试剂肠道病变平均检出成本分别为每例5 874.50和1 432.14元.结论 粪隐血定量试剂对结直肠癌筛查效果优于定性试剂,但筛查成本前者是后者的4.10倍.

Objective To investigate the application effects of quantitative and qualitative fecal occult blood (FOB) reagent in colorectal cancer screening.Methods With the platform of colorectal cancer screening for early diagnosis and treatment,the original screening methods and process were not changed,individuals underwent colorectal cancer screening,aged from 40 to 74 years old,from four villages of Haining City in Zhejiang Province were selected as study objects.Initial screening included medical history questionnaire and FOB test.The first stool samples were examined both with quantitative and qualitative FOB test,one week later the second samples were detected with qualitative FOB test.History positive or once of any type of reagent positive was considered as initial screening positive.The individuals with initial screening positive received fine screening (colon endoscope examination).The effects evaluation included the positive rate of FOB,intestinal lesion detection rate,sensitivity,specificity and Youden index.The health economic analysis was calculated.Chi-square test was performed for comparisons between the two groups.Results A total of 8 427 history survey were completed,the positive rate of history was 8.48％(715/8 427) ; 6 644 underwent quantitative detection of FOB and the positive rate was 4.44 ％ (295/6 644) ; qulitative test was conducted in 12 633 samples were conducted and the positive rate was 2.56 ％ (324/12 633),the difference was statistically significant (x2 =49.27,P＜ 0.01).A total of 854 individuals with initial screening positive underwent electronic colonoscopy examination,the total intestinal lesion detection rate was 22.72％ (194/854),of which the intestinal lesion detection rate of quantitative group was 34.55％ (66/191),and that of qualitative group was 17.73％ (36/203),the difference was statistically significant (x2 =14.53,P＜0.01).The detection rate of both quantitative and qualitative test positive was 43.75 ％ (14/32).The colorectal cancer detection rates of quantitative and qualitative FOB test were 3.66％ (7/191) and 0.99％ (2/203),advanced adenoma detection rates were 8.38 ％ (16/191) and 5.91％,there were no significant differences (x2 =2.08 and 0.96,both P＞0.05).The sensitivity of quantitative and qualitative FOB test in advanced adenoma and cancer detection rate was 45.10％ and 27.45％,respectively.The average cost of quantitative and qualitative FOB test in intestinal lesions detection was 5 874.50 and 1 432.14 yuan.Conclusion The effects of quantitative FOB test in colorectal cancer screening was better than that of qualitative reagent,however on the cost of screening,the former was 4.10 times of the latter.