Risk of colorectal cancer seven years after flexible sigmoidoscopy screening: randomised controlled trial
Risk of colorectal cancer seven years after flexible sigmoidoscopy screening: randomised controlled trial
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DOI：
10.1136/bmj.b1846
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发表时间：
2009-05-31
影响因子：
105.7
通讯作者：
Bretthauer, Michael
中科院分区：
文献类型：
--
作者：
Hoff, Geir;Grotmol, Tom;Bretthauer, Michael
目的确定软式乙状结肠镜筛查后结直肠癌的风险。设计随机对照试验。设置在挪威的两个地区--奥斯陆市和泰勒马克县进行基于人群的筛查（城市和城乡混合人口）。参与者55 736名年龄在55-64岁的男性和女性。干预一次仅进行乙状结肠镜筛查，有或没有单轮粪便潜血试验（n= 13823）与未筛查（n= 41913）相比。主要结果测量计划终点为5年、10年和15年后结直肠癌的累积发病率和死亡率。这第一份报告，从研究提出的累积发病率后7年的后续行动和风险比死亡后6 years.Results没有发现差异，在7年的累积发病率之间的结直肠癌的筛查和对照组（134.5比131.9例每10万人年）。在意向筛查分析中，发现结直肠癌死亡率有降低的趋势（风险比0.73，95%置信区间0.47至1.13，P=0.16）。与对照组相比，参加者的死亡率在统计学上显著降低，（风险比0.41，0.21至0.82，P=0.011）和直肠乙状结肠癌（0.24，0.08至0.76，结论随访7年后，乙状结肠镜筛查并不能降低结直肠癌的发病率。筛查组的结直肠癌死亡率没有显著降低，但似乎更低，在符合方案分析中，任何部位的结直肠癌和直肠乙状结肠癌的死亡率降低了59%，这是一项容易产生选择偏倚的分析。
Objective To determine the risk of colorectal cancer after screening with flexible sigmoidoscopy.Design Randomised controlled trial.Setting Population based screening in two areas in Norway-city of Oslo and Telemark county (urban and mixed urban and rural populations).Participants 55 736 men and women aged 55-64 years.Intervention Once only flexible sigmoidoscopy screening with or without a single round of faecal occult blood testing (n=13 823) compared with no screening (n=41 913).Main outcome measures Planned end points were cumulative incidence and mortality of colorectal cancer after 5, 10, and 15 years. This first report from the study presents cumulative incidence after 7 years of follow-up and hazard ratio for mortality after 6 years.Results No difference was found in the 7 year cumulative incidence of colorectal cancer between the screening and control groups (134.5 v 131.9 cases per 100 000 person years). In intention to screen analysis, a trend towards reduced colorectal cancer mortality was found (hazard ratio 0.73, 95% confidence interval 0.47 to 1.13, P=0.16). For attenders compared with controls, a statistically significant reduction in mortality was apparent for both total colorectal cancer (hazard ratio 0.41, 0.21 to 0.82, P=0.011) and rectosigmoidal cancer (0.24, 0.08 to 0.76, P=0.016).Conclusions A reduction in incidence of colorectal cancer with flexible sigmoidoscopy screening could not be shown after 7 years' follow-up. Mortality from colorectal cancer was not significantly reduced in the screening group but seemed to be lower for attenders, with a reduction of 59% for any location of colorectal cancer and 76% for rectosigmoidal cancer in per protocol analysis, an analysis prone to selection bias.Trial registration Clinical trials NCT00119912.