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重复两样本粪便免疫化学试验筛查结直肠癌的就诊率和诊断率。

Attendance and diagnostic yield of repeated two-sample faecal immunochemical test screening for colorectal cancer.

机构信息

Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.

Department of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands.

出版信息

Gut. 2017 Jan;66(1):118-123. doi: 10.1136/gutjnl-2014-308957. Epub 2015 Sep 14.

Abstract

OBJECTIVE

Limited data exist on attendance and additional yield of 2-sample faecal immunochemical testing (FIT) screening during multiple rounds. We therefore conducted a population-based colorectal cancer screening trial comparing attendance and yield of repeated 1-sample and 2-sample FIT screenings.

DESIGN

Two randomly selected groups of average-risk subjects aged 50-74 years were invited for two rounds of either 1-sample (n=5007) or 2-sample (n=3197) FIT (OC-sensor Micro) screening. The test was considered positive if at least one sample was positive (cut-off 50 ng/mL; 10 µg haemoglobin/g).

RESULTS

The cumulative attendance rate was similar for repeated 1-sample and 2-sample FIT screenings (1-sample FIT: 68.1%; 2-sample FIT: 67.1%, p=0.368). The positivity rate in the second round was lower for 1-sample FIT (6.2%, 95% CI 5.4% to 7.2%) than for 2-sample FIT (8.4%, 95% CI 7.1% to 9.8%, p=0.007), whereas the detection rate of advanced neoplasia (AN, 1-sample FIT: 1.9%, 95% CI 1.2% to 2.2%; 2-sample FIT: 1.7%, 95% CI 1.2% to 2.5%, p=0.861) and the positive predictive value (1-sample FIT: 32%, 95% CI 24% to 40%; 2-sample FIT: 21%, 95% CI 15% to 29%, p=0.075) did not differ. After two rounds of screening, the cumulative diagnostic yield of AN for 1-sample FIT was 29.3 per 1000 invitees, compared with 34.0 for 2-sample FIT (p=0.241).

CONCLUSIONS

Using 2-sample FIT instead of 1-sample FIT does not result in a higher detection rate of AN in the second round of repeated FIT screening. Furthermore, both strategies lead to a similar yield of AN over two rounds. These findings imply that 1-sample FIT screening is preferred over 2-sample FIT screening.

摘要

目的

关于多次轮次中进行两样本粪便免疫化学检测(FIT)筛查的出席率和额外检出率,目前仅有有限的数据。因此,我们开展了一项基于人群的结直肠癌筛查试验,比较了重复进行单样本和双样本 FIT 筛查的出席率和检出率。

设计

随机选择两组年龄在 50-74 岁的一般风险受试者,邀请他们参加两轮单样本(n=5007)或双样本(n=3197)FIT(OC-sensor Micro)筛查。如果至少一个样本呈阳性(截止值 50ng/mL;10µg 血红蛋白/g),则认为该检测为阳性。

结果

重复进行单样本和双样本 FIT 筛查的累积出席率相似(单样本 FIT:68.1%;双样本 FIT:67.1%,p=0.368)。第二轮单样本 FIT 的阳性率(6.2%,95%CI 5.4%至 7.2%)低于双样本 FIT(8.4%,95%CI 7.1%至 9.8%,p=0.007),而高级别肿瘤(AN,单样本 FIT:1.9%,95%CI 1.2%至 2.2%;双样本 FIT:1.7%,95%CI 1.2%至 2.5%,p=0.861)的检出率和阳性预测值(单样本 FIT:32%,95%CI 24%至 40%;双样本 FIT:21%,95%CI 15%至 29%,p=0.075)并无差异。两轮筛查后,单样本 FIT 的 AN 累积诊断率为每 1000 名受邀者 29.3 例,而双样本 FIT 为 34.0 例(p=0.241)。

结论

与单样本 FIT 相比,使用双样本 FIT 不会导致第二轮重复 FIT 筛查中 AN 的检出率更高。此外,两种策略在两轮筛查中均导致 AN 的检出率相似。这些发现意味着单样本 FIT 筛查优于双样本 FIT 筛查。

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