| 张 娟,钱立庭,魏东华.不同筛查方案结直肠癌筛查随机对照试验基线结果分析[J].中国肿瘤,2021,30(11):806-812. |
| 不同筛查方案结直肠癌筛查随机对照试验基线结果分析 |
| Baseline Analysis on Randomized Controlled Trial of Different Protocols in Colorectal Cancer Screening |
| 中文关键词 修订日期：2021-07-07 |
| DOI：10.11735/j.issn.1004-0242.2021.11.A002 |
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| 中文关键词: 结直肠癌 筛查 早诊早治 结肠镜检查 安徽 |
| 英文关键词:colorectal cancer screening early diagnosis and treatment colonoscopy Anhui |
| 基金项目:中国医学科学院医学与健康科技创新工程重大协同创新项目（2017?鄄I2M?鄄1?鄄006）；国家自然科学基金青年项目（71804002） |
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| 中文摘要: |
| 摘 要：［目的］ 分析结肠镜、粪便隐血试验（FIT）及风险评估筛查方案的人群结直肠癌筛查参与率和筛查效果。［方法］ 2018年5月至2019年5月，在安徽省合肥市招募50～74岁且符合研究要求的受试者，将其随机分配到3个筛查组（按1∶2∶2的比例）：结肠镜组、FIT组、风险评估组。所有受试者进行风险调查和评估，结肠镜组进行结肠镜检查，FIT组进行FIT检测，阳性者行结肠镜检查，风险评估组评估为高危者进行结肠镜检查，低危者进行FIT检测。计算不同筛查方案的参与率、检出率和阳性预测值。［结果］ 共计招募3 821名受试者，结肠镜组、FIT组、风险评估组的参与率分别是45.3%（347/766）、96.0%（1 470/1 532）、86.0%(1 310/1 523)；结肠镜检查参与率分析显示，FIT组阳性人群参与率最高为80.6%，结肠镜组最低为45.3%，差异有统计学意义（P＜0.05）；三组筛查方法在进展期肿瘤检出率方面，差异无统计学意义（P＞0.05）。FIT组阳性对于进展期腺瘤阳性预测值最高（P＜0.05）。在筛查中所需结肠镜检查负荷指标上，每检出1例进展期肿瘤所需要的结肠镜检查数，结肠镜组为20例，FIT组为10例，风险评估组为19例。［结论］ FIT组及风险评估组显示出较高的参与率，在人群筛查中所需结肠镜检查的负荷数量方面，FIT法展示了较好的筛查效率。 |
| 英文摘要: |
| Abstract：［Purpose］ To analyze the performance of protocols of colonoscopy，fecal immunochemical test(FIT) and risk assessment in colorectal cancer screening. ［Methods］ From May 2018 to May 2019，eligible participants aged 50～74 years in Anhui Province were recruited and randomly allocated into colonoscopy group，FIT group and risk assessment screening group for screening of colorectal cancer with a ratio of 1∶2∶2. Colonoscopy group was directly subjected to colonoscopy; FIT group was subjected to FIT test，for those with positive result subjected to colonoscopy; and risk assessment group was subjected to risk assessment，in which colonoscopy was performed for those with high-risk and FIT test was given for those with low-risk. Participation rate，detection rate and positive predictive value in all three groups were calculated. ［Results］ A total of 3 821 subjects were recruited. The participation rates of the colonoscopy，FIT and risk assessment screening groups were 45.3%(347/766)，96.0%(1 470/1 532) and 86.0%(1 310/1 523)，respectively. The compliance rate of colonoscopy was 80.6% in the FIT positive subjects，which was significantly higher than that in colonoscopy group（45.3%，P＜0.05）. There was no significant difference in the detection rate of advanced tumor among three groups(P＞0.05). The positive predictive value for advanced adenoma in FIT positive group was the highest(P<0.05).The number needed for colonoscopy to detect one advanced tumor were 20，10 and 19 cases for three groups，respectively. ［Conclusion］ The FIT and risk assessment screening approaches show high participation rates. In terms of the number needed for colonoscopy to detect one advanced tumor，FIT method showed better screening effect. |
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