| 卢明,陈宏达,刘成成,张愉涵,魏锣沛,吕章艳,任建松,石菊芳,邹霜梅,李霓,代敏.定量免疫粪便隐血试验对进展期结直肠肿瘤筛检效能的评价[J].Chinese journal of Epidemiology,2020,41(12):2104-2111 |
| 定量免疫粪便隐血试验对进展期结直肠肿瘤筛检效能的评价 |
| Diagnostic performance of quantitative fecal immunochemical test in detection of advanced colorectal neoplasia |
| Received:December 16, 2019 |
| DOI：10.3760/cma.j.cn112338-20191216-00888 |
| KeyWord: 结直肠肿瘤 定量免疫粪便隐血试验 筛查 |
| English Key Word: Colorectal neoplasm Quantitative fecal immunochemical testing Screening |
| FundProject:中国医学科学院医学与健康科技创新工程（2017-I2M-1-006，2019-I2M-2-002）；国家自然科学基金（81703309）；北京市科技新星计划（Z191100001119065）；北京市自然科学基金（7202169） |
| Author Name | Affiliation | E-mail | | Lu Ming | Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China | | | Chen Hongda | Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China | | | Liu Chengcheng | Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China | | | Zhang Yuhan | Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China | | | Wei Luopei | Department of Science and Development, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou 310009, China | | | Lyu Zhangyan | Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Department of Epidemiology and Biostatistics, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Hospital, Tianjin 300060, China | | | Ren Jiansong | Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China | | | Shi Jufang | Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China | | | Zou Shuangmei | Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China | | | Li Ni | Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China | | | Dai Min | Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China | daimin2002@hotmail.com |
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| Abstract: |
| 目的 评价定量免疫粪便隐血试验（FIT）对进展期结直肠肿瘤（结直肠癌和进展期腺瘤）的筛检效能，为进一步优化中国人群结直肠癌筛查策略提供理论参考。方法 基于1项正在开展的人群结直肠癌筛查随机对照试验，选取3 407例已完成结肠镜检查的50~74岁受试者作为研究对象。所有受试者在结肠镜检查前均提供粪便标本。采用定量FIT通过标准化操作流程对所有粪便标本进行检测。以结肠镜和病理结果作为金标准，计算定量FIT对进展期结直肠肿瘤的筛检效能指标。结果 3 407例受试者中男性占51.5%（n=1 753），年龄为（60.5±6.3）岁，共包括结直肠癌28例（0.8%）、进展期腺瘤255例（7.5%）、非进展期腺瘤677例（19.9%）、良性病变和正常者2 447例（71.8%）。当采用厂家推荐阳性截断值（20 μg Hb/g）时，总体FIT阳性率为2.8%（96/3 407），对于结直肠癌和进展期腺瘤的灵敏度分别为57.1%（95% CI：37.2%~75.5%）和11.0%（95% CI：7.4%~15.5%），特异度为98.4%（95% CI：97.8%~98.8%）。当阳性截断值调整至5 μg Hb/g时，定量FIT对于结直肠癌和进展期腺瘤的灵敏度分别增加至64.3%（95% CI：44.1%~81.4%）和16.5%（95% CI：12.1%~21.6%），特异度降低至95.2%（95% CI：94.4%~95.9%）。受试者工作曲线分析结果显示，FIT对于结直肠癌和进展期腺瘤的曲线下面积分别为0.908（95% CI：0.842~0.973）、0.657（95% CI：0.621~0.692），且在不同性别、年龄组人群中筛检效能较为一致。结论 在本研究中，定量FIT对结直肠癌诊断灵敏度尚可，但对进展期腺瘤的诊断灵敏度较低。在人群结直肠癌筛查中，定量FIT的阳性截断值可以根据预设检出率及结肠镜检查负荷灵活调整，具有一定优势。 |
| English Abstract: |
| Objective To evaluate the diagnostic performance of quantitative fecal immunochemical testing (FIT) and to provide reference for designing effective colorectal cancer (CRC) screening strategy in China. Methods Based on an ongoing randomized controlled trial comparing the colorectal cancer screening strategies, this current study involved 3 407 participants aged 50-74 years who had undergone colonoscopies. All the feces samples were collected from the participants prior to receiving the colonoscopy. Fecal hemoglobin (Hb) was tested by FIT following a standardized operation process. Diagnosis-related indicators of FIT were calculated using the colonoscopy results as the gold standard. Results Among the 3 407 participants, the mean age (SD) as 60.5 (6.3) years and 1 753 (51.5%) were males. The participants involved 28 (0.8%) CRCs, 255 (7.5%) advanced adenomas, 677 (19.9%) nonadvanced adenomas, and 2 447 (71.8%) benign or negative findings. With an overall positivity rate of 2.8% (96/3 407) at the recommended cutoff value of 20 μg Hb/g, the sensitivities of FIT for both CRC and advanced adenoma were 57.1% (95% CI:37.2%-75.5%) and 11.0% (95% CI:7.4%-15.5%), respectively, with the corresponding specificity as 98.4% (95% CI:97.8%-98.8%). At a decreased cut-off value of 5 μg Hb/g, the sensitivities for detecting CRC and advanced adenoma increased to 64.3% (95% CI:44.1%-81.4%) and 16.5% (95% CI:12.1%-21.6%), respectively, but the specificity reduced to 95.2% (95% CI:94.4%-95.9%). The areas under the ROC curve for CRC and advanced adenoma were 0.908 (95% CI:0.842-0.973) and 0.657 (95% CI:0.621-0.692), respectively. Of the diagnostic performance, there were no significant differences noticed by different sex and age groups. Conclusions In our study, the quantitative FIT showed modest sensitivity in detecting CRC but limited sensitivity in detecting advanced adenoma. In population-based CRC screening programs, the quantitative FIT had the advantage of adjusting the positive threshold based on the targeted detection rate and available resource load of colonoscopy. |
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