New immunochemical fecal occult blood test with two-consecutive stool sample testing is a cost-effective approach for colon cancer screening: Results of a prospective multicenter study in Chinese patients

New immunochemical fecal occult blood test with two-consecutive stool sample testing is a cost-effective approach for colon cancer screening: Results of a prospective multicenter study in Chinese patients
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DOI:
10.1002/ijc.21774
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发表时间:
2006-06-15
影响因子:
6.4
通讯作者:
Rao, Jianyu
Rao, Jianyu
中科院分区:
医学1区
文献类型:
--
作者:
Li, Shirong;Wang, Huahong;Rao, Jianyu

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本研究的目的是评价一种新的免疫化学粪便潜血试验方法(Hemosure IFOBT),并将其与基于愈创木酸的化学方法(CFOBT)进行比较,用于结直肠癌检测。还评价了假设序贯法(SFOBT),其中IFOBT仅用作CFOBT的确证试验。从中国北京的5家主要医院共招募了324名患者。对于每名患者,连续采集3份粪便样本,同时进行CFOBT和IFOBT检测,然后进行结肠镜检查。我们比较了3种方法(CFOBT,IFOBT和SFOBT)在两种情况下的灵敏度和特异性,前2个连续样本与所有3个样本。尽管在三样本设置中,所有3种方法检测癌症和大(> 20 mm)或多发性腺瘤的灵敏度相似,但在两样本设置中,IFOBT检测癌症的灵敏度高于SFOBT(分别为87.8%和75.5%,p < 0.05)和大腺瘤(> 20分钟)或多发性腺瘤(分别为65.4%和42.3%,p < 0.05)。IFOBT也比CFOBT具有更高的特异性(分别为89.2%和75.5%,p < 0.01),在三样本设置中通过结肠镜检查定义的“正常”个体中。比较两个样本设置的三个样本设置,CFOBT和SFOBT显示出显着的损失的灵敏度检测癌症以及腺瘤,而IFOBT的灵敏度没有显着变化。总的来说,IFOBT与两个样本测试显示出兼容的灵敏度和特异性的三个样本测试,并有一个较低的相对成本比三个样本测试发现的癌症。总之,采用两个连续粪便样本的新型Hemosure IFOBT似乎是结肠癌筛查的最具成本效益的方法。(c)2006威利-利斯公司
The purpose of the study is to evaluate a new immunochemical fecal occult blood test method (Hemosure IFOBT), and compare it to the Guaiac-based chemical method (CFOBT) for colorectal cancer detection. A hypothetical sequential method (SFOBT), in which IFOBT was used only as a confirmatory test for CFOBT, was also evaluated. A total of 324 patients were recruited from 5 major hospitals in Beijing, China. For each patient, 3 consecutive stool samples were collected for simultaneous CFOBT and IFOBT tests, followed by colonoscopic examination. We compared the sensitivity and specificity of the 3 methods (CFOBT, IFOBT and SFOBT) in two settings, with the first 2 consecutive samples versus all 3 samples. Although the sensitivity for the detection of cancer and large (> 20 mm) or multiple adenoma was similar for all 3 methods in the three-sample setting, in the two-sample setting IFOBT had higher sensitivity than SFOBT for detecting cancer (87.8% vs. 75.5%, respectively, p < 0.05) and large (> 20 min) or multiple adenomas (65.4% vs. 42.3%, respectively, p < 0.05). The IFOBT also had a higher specificity than the CFOBT (89.2% vs. 75.5%, respectively, p < 0.01) in '' normal '' individuals defined by colonoscopy in the three-sample setting. Comparing two-sample setting to the three-sample setting, both CFOBT and SFOBT showed significant loss of sensitivity for the detection of cancer as well as adenoma, whereas the sensitivity for IFOBT did not change significantly. Overall, IFOBT with two-sample testing showed compatible sensitivity and specificity to the three-sample testing, and had a lower relative cost per cancer detected than the three-sample testing. In conclusion, the new Hemosure IFOBT with two consecutive stool samples appears to be the most cost-effective approach for colon cancer screening. (c) 2006 Wiley-Liss, Inc.