Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Clin Gastroenterol Hepatol. 2011 Apr;9(4):333-9. doi: 10.1016/j.cgh.2010.12.012. Epub 2010 Dec 23.
BACKGROUND & AIMS: The fecal immunochemical test (FIT) is superior to the guaiac-based fecal occult blood test in detecting neoplasia. There are not much data on the optimal number of FITs to perform. We conducted a population-based trial to determine attendance and diagnostic yield of 1- and 2-sample FIT screening.
The study included 2 randomly selected groups of subjects aged 50-74 years (1-sample FIT, n=5007; 2-sample FIT, n=3197). The 2-sample group was instructed to collect fecal samples on 2 consecutive days. Subjects were referred for colonoscopy when at least 1 sample tested positive (≥50 ng hemoglobin/mL).
Attendance was 61.5% in the 1-sample group (2979 of 4845; 95% confidence interval, 60.1%-62.9%) and 61.3% in the 2-sample group (1875 of 3061; 95% confidence interval, 59.6%-63.0%; P=.84). In the 1-sample group 8.1% tested positive, and in the 2-sample group 12.8% had at least 1 positive test outcome and 5.0% had 2 positive test outcomes (P<.05). When the mean from both test results in the 2-sample group was used, 10.1% had a positive test outcome (P<.05). The detection rates for advanced neoplasia were 3.1% in the 1-sample group, 4.1% in the 2-sample group with at least 1 positive test outcome, 2.5% when both test results were positive, and 3.7% among subjects with the mean from both test results being positive.
There is no difference in attendance for subjects offered 1- or 2-sample FIT screening. The results allow for the development of efficient FIT screening strategies that can be adapted for local colonoscopy capacities, rather than varying the cut-off value in a 1-sample strategy.
粪便免疫化学检测（FIT）在检测肿瘤方面优于愈创木脂粪便潜血检测。关于进行多少次 FIT 的最佳数据并不多。我们进行了一项基于人群的试验，以确定 1 次和 2 次样本 FIT 筛查的参与率和诊断收益。
该研究纳入了两组年龄在 50-74 岁之间的随机选择的受试者（1 次样本 FIT 组，n=5007；2 次样本 FIT 组，n=3197）。2 次样本组被指示连续两天采集粪便样本。当至少有 1 个样本检测结果阳性（≥50ng 血红蛋白/mL）时，对受试者进行结肠镜检查。
1 次样本组的参与率为 61.5%（4845 例中的 2979 例；95%置信区间，60.1%-62.9%），2 次样本组为 61.3%（3061 例中的 1875 例；95%置信区间，59.6%-63.0%；P=.84）。在 1 次样本组中，8.1%的样本检测结果阳性，在 2 次样本组中，12.8%的样本至少有 1 个阳性检测结果，5.0%的样本有 2 个阳性检测结果（P<.05）。当使用 2 次样本组的平均结果时，10.1%的样本检测结果阳性（P<.05）。在 1 次样本组中，高级别肿瘤的检出率为 3.1%，在 2 次样本组中，至少有 1 个阳性检测结果的检出率为 4.1%，2 次检测结果均阳性的检出率为 2.5%，2 次检测结果平均值阳性的检出率为 3.7%。
接受 1 次或 2 次样本 FIT 筛查的受试者的参与率没有差异。这些结果为制定高效的 FIT 筛查策略提供了依据，可以根据当地结肠镜检查能力进行调整，而无需改变 1 次样本策略中的截止值。
