Limburg Paul J, Devens Mary E, Harrington Jonathan J, Diehl Nancy N, Mahoney Douglas W, Ahlquist David A
Division of Gastroenterology and Hepatology and Department of Biostatistics, Mayo Clinic, Rochester, Minnesota 55905, USA.
Am J Gastroenterol. 2003 Oct;98(10):2299-305. doi: 10.1111/j.1572-0241.2003.07630.x.
Stool testing is a well established method of screening for colorectal neoplasia. Emerging data suggest that novel biomarkers may offer performance advantages over fecal occult blood. In this large, prospective study, we assessed fecal calprotectin (a leukocyte-derived protein) as a screening biomarker for colorectal neoplasia. Fecal calprotectin was directly compared to fecal hemoglobin (Hb) and colonoscopy as the existing criterion standards for stool screening and structural evaluation, respectively.
Subjects included colonoscopy patients with a personal history of colorectal neoplasia, family history of colorectal cancer, or iron deficiency anemia. Stool specimens were collected before purgation, processed appropriately, and quantitatively analyzed for calprotectin (Nycomed Pharma, Oslo, Norway) and for Hb (Mayo Medical Laboratories, Rochester, MN) by masked technicians. Colonoscopies were performed by experienced endoscopists without prior knowledge of the fecal assay results.
Among 412 subjects, 97 (24%) subjects had one or more colorectal neoplasms (including three with adenocarcinomas). Fecal calprotectin levels did not differ significantly between subjects with versus subjects without colorectal neoplasms (p = 0.33). Neither tumor number (p = 0.85) nor tumor size (p = 0.86) significantly influenced the observed fecal calprotectin concentrations. Estimates of the sensitivity, specificity, and positive and negative predictive values of fecal calprotectin for any colorectal neoplasms were 37%, 63%, 23%, and 76%, respectively. Comparable performance estimates for fecal Hb were 3%, 97%, 27%, and 77%, respectively.
In this cohort of colonoscopy patients at above average risk, fecal calprotectin was a poor screening biomarker for colorectal neoplasia. Further investigation of tumor-derived, rather than blood-based, biomarkers may be a more rewarding approach to stool screening for colorectal neoplasia.
粪便检测是一种成熟的结直肠肿瘤筛查方法。新出现的数据表明，新型生物标志物在性能上可能优于粪便潜血检测。在这项大型前瞻性研究中，我们评估了粪便钙卫蛋白（一种白细胞衍生蛋白）作为结直肠肿瘤筛查生物标志物的情况。将粪便钙卫蛋白分别与粪便血红蛋白（Hb）以及结肠镜检查进行直接比较，后者分别作为粪便筛查和结构评估的现有标准方法。
研究对象包括有结直肠肿瘤个人史、结直肠癌家族史或缺铁性贫血的结肠镜检查患者。在清肠前收集粪便标本，进行适当处理，由不知情的技术人员对钙卫蛋白（挪威奥斯陆Nycomed制药公司）和Hb（美国明尼苏达州罗切斯特市梅奥医学实验室）进行定量分析。结肠镜检查由经验丰富的内镜医师进行，他们事先不知道粪便检测结果。
在412名研究对象中，97名（24%）有一个或多个结直肠肿瘤（包括3例腺癌）。有结直肠肿瘤的研究对象与无结直肠肿瘤的研究对象之间，粪便钙卫蛋白水平无显著差异（p = 0.33）。肿瘤数量（p = 0.85）和肿瘤大小（p = 0.86）均未对观察到的粪便钙卫蛋白浓度产生显著影响。粪便钙卫蛋白对任何结直肠肿瘤的敏感性、特异性、阳性预测值和阴性预测值估计分别为37%、63%、23%和76%。粪便Hb的相应性能估计分别为3%、97%、27%和77%。
在这组平均风险以上的结肠镜检查患者中，粪便钙卫蛋白是一种较差的结直肠肿瘤筛查生物标志物。进一步研究肿瘤来源而非血液来源的生物标志物，可能是结直肠肿瘤粪便筛查更有价值的方法。
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