Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial.
Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial.
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DOI：
10.1001/jama.2014.8266
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发表时间：
2014-08-13
影响因子：
120.7
通讯作者：
Hoff, Geir
中科院分区：
文献类型：
--
作者：
Holme, Oyvind;Loberg, Magnus;Kalager, Mette;Bretthauer, Michael;Hernan, Miguel A.;Aas, Eline;Eide, Tor J.;Skovlund, Eva;Schneede, Jorn;Tveit, Kjell Magne;Hoff, Geir
结直肠癌是一个主要的健康负担。许多国家建议进行筛查。在一项基于人群的试验中评估乙状结肠镜筛查对结直肠癌发病率和死亡率的有效性在50-64岁人群中进行的随机对照试验。1999-2000年（55-64岁年龄组）和2001年（50-54岁年龄组）进行了筛查。随访结束：2011年12月31日。挪威奥斯陆市和泰勒马克县的人口。在筛查区确定了100 210人。1，415名患者因既往结直肠癌、移民或死亡而被排除。在人口登记册中找不到三个人。随机分配至筛选组的个体被邀请进行筛选。在筛查组中，个体以1：1的比例随机分配至仅一次软式乙状结肠镜检查或仅一次软式乙状结肠镜检查和粪便潜血试验（FOBT）的组合。筛选试验阳性的个体（癌症、腺瘤、息肉≥10 mm或FOBT阳性）接受结肠镜检查。对照组不接受任何干预。结直肠癌发病率和死亡率。98,792人被纳入意向筛查分析;对照组78,220人，筛查组20,572人（10,283人随机接受软式乙状结肠镜检查，10,289人随机接受软式乙状结肠镜检查和FOBT）。筛查依从性为63%。中位10.9年后，筛选组有71人死于结直肠癌，对照组有330人（31.4 vs. 43.1例死亡，绝对率差异为11.7（95% CI 3.0-20.4）/100，000人-年）;风险比[HR] 0.73（95%置信区间[CI] 0.56-0.94）。筛查组有253例患者确诊为结直肠癌，对照组有1，086例患者确诊为结直肠癌（112.6 vs. 141.0例，绝对率差：28.4（95% CI 12.1-44.7）/100，000人-年）; HR 0.80（95% CI 0.70-0.92）。50-54岁年龄组（HR 0.68; 95% CI 0.49-0.94）和55-64岁年龄组（HR 0.83; 95% CI 0.71-0.96）的结直肠癌发病率均降低。仅软式乙状结肠镜检查组与软式乙状结肠镜检查/FOBT筛查组之间无差异。在挪威，与不进行筛查相比，仅进行一次软式乙状结肠镜检查筛查或软式乙状结肠镜检查和FOBT可降低人群结直肠癌的发病率和死亡率。筛查在50-54岁和55-64岁年龄组中均有效。临床试验标识符NTC 00119912，http://clinicaltrials.gov
Colorectal cancer is a major health burden. Screening is recommended in many countries. Estimate the effectiveness of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality in a population-based trial. Randomized controlled trial in individuals aged 50–64 years. Screening was performed in 1999–2000 (55–64 year age-group) and 2001 (50–54 year age-group). End of follow-up: Dec 31st 2011. Population of Oslo city and Telemark County, Norway. 100,210 individuals were identified in the screening areas. 1,415 individuals were excluded due to prior colorectal cancer, emigration, or death. Three individuals could not be traced in the population registry. Individuals randomized to the screening group were invited to screening. Within the screening group, individuals were randomized 1:1 to once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood-testing (FOBT). Individuals with positive screening test (cancer, adenoma, polyp ≥10 mm, or positive FOBT) were offered colonoscopy. The control group received no intervention. Colorectal cancer incidence and mortality. 98,792 individuals were included in the intention to screen analyses; 78,220 in the control group and 20,572 in the screening group (10,283 randomized to flexible sigmoidoscopy and 10,289 to flexible sigmoidoscopy and FOBT). Compliance with screening was 63%. After median 10.9 years, 71 individuals had died from colorectal cancer in the screening group, and 330 in the control group (31.4 vs. 43.1 deaths, absolute rate difference 11.7 (95% CI 3.0–20.4) per 100,000 person-years); hazard ratio [HR] 0.73 (95% confidence interval [CI] 0.56–0.94). Colorectal cancer was diagnosed in 253 individuals in the screening group, and 1,086 in the control group (112.6 vs. 141.0 cases, absolute rate difference: 28.4 (95% CI 12.1–44.7) per 100,000 person-years); HR 0.80 (95% CI 0.70–0.92). Colorectal cancer incidence was reduced in both the 50–54 year age-group (HR 0.68; 95% CI 0.49–0.94) and the 55–64 year age-group (HR 0.83; 95% CI 0.71–0.96). There was no difference between the flexible sigmoidoscopy only and the flexible sigmoidoscopy/FOBT screening groups. In Norway, once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening. Screening was effective both in the 50–54 and the 55–64 year age-group. ClinicalTrials identifier NTC00119912, http://clinicaltrials.gov
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影响因子：
105.7
作者：
Hoff, Geir;Grotmol, Tom;Bretthauer, Michael
通讯作者：
Bretthauer, Michael
影响因子：
5.5
作者：
Lansdorp-Vogelaar I;Knudsen AB;Brenner H
通讯作者：
Brenner H
影响因子：
6.2
作者：
MUTO, T;BUSSEY, HJR;MORSON, BC
通讯作者：
MORSON, BC
影响因子：
24.5
作者：
Gondal, G;Grotmol, T;Hoff, G
通讯作者：
Hoff, G
影响因子：
8.4
作者：
Larsen, Inger Kristin;Smastuen, Milada;Moller, Bjorn
通讯作者：
Moller, Bjorn