结肠镜筛查对女性和男性结直肠癌发病率和死亡率的长期效果：一项随机试验。
Long-Term Effectiveness of Sigmoidoscopy Screening on Colorectal Cancer Incidence and Mortality in Women and Men: A Randomized Trial.
机构信息
Sørlandet Hospital Kristiansand, Kristiansand, Norway, and University of Oslo Institute of Health and Society and Oslo University Hospital, Oslo, Norway (Ø.H., M.L., M.B., T.J.E.).
University of Oslo Institute of Health and Society and Oslo University Hospital, Oslo, Norway, and Harvard T.H. Chan School of Public Health and Harvard-MIT Division of Health Sciences and Technology, Boston, Massachusetts (M.K., M.A.H.).
出版信息
Ann Intern Med. 2018 Jun 5;168(11):775-782. doi: 10.7326/M17-1441. Epub 2018 Apr 24.
BACKGROUND
The long-term effects of sigmoidoscopy screening on colorectal cancer (CRC) incidence and mortality in women and men are unclear.
OBJECTIVE
To determine the effectiveness of flexible sigmoidoscopy screening after 15 years of follow-up in women and men.
DESIGN
Randomized controlled trial. (ClinicalTrials.gov: NCT00119912).
SETTING
Oslo and Telemark County, Norway.
PARTICIPANTS
Adults aged 50 to 64 years at baseline without prior CRC.
INTERVENTION
Screening (between 1999 and 2001) with flexible sigmoidoscopy with and without additional fecal blood testing versus no screening. Participants with positive screening results were offered colonoscopy.
MEASUREMENTS
Age-adjusted CRC incidence and mortality stratified by sex.
RESULTS
Of 98 678 persons, 20 552 were randomly assigned to screening and 78 126 to no screening. Adherence rates were 64.7% in women and 61.4% in men. Median follow-up was 14.8 years. The absolute risks for CRC in women were 1.86% in the screening group and 2.05% in the control group (risk difference, -0.19 percentage point [95% CI, -0.49 to 0.11 percentage point]; HR, 0.92 [CI, 0.79 to 1.07]). In men, the corresponding risks were 1.72% and 2.50%, respectively (risk difference, -0.78 percentage point [CI, -1.08 to -0.48 percentage points]; hazard ratio [HR], 0.66 [CI, 0.57 to 0.78]) (P for heterogeneity = 0.004). The absolute risks for death from CRC in women were 0.60% in the screening group and 0.59% in the control group (risk difference, 0.01 percentage point [CI, -0.16 to 0.18 percentage point]; HR, 1.01 [CI, 0.77 to 1.33]). The corresponding risks for death from CRC in men were 0.49% and 0.81%, respectively (risk difference, -0.33 percentage point [CI, -0.49 to -0.16 percentage point]; HR, 0.63 [CI, 0.47 to 0.83]) (P for heterogeneity = 0.014).
LIMITATION
Follow-up through national registries.
CONCLUSION
Offering sigmoidoscopy screening in Norway reduced CRC incidence and mortality in men but had little or no effect in women.
PRIMARY FUNDING SOURCE
Norwegian government and Norwegian Cancer Society.
背景
乙状结肠镜筛查对女性和男性结直肠癌（CRC）发病率和死亡率的长期影响尚不清楚。
目的
确定女性和男性在 15 年随访后接受乙状结肠镜筛查的效果。
设计
随机对照试验。（ClinicalTrials.gov：NCT00119912）。
地点
挪威奥斯陆和泰勒马克郡。
参与者
基线时年龄在 50 至 64 岁且无先前 CRC 的成年人。
干预措施
筛查（1999 年至 2001 年），采用乙状结肠镜检查和/或粪便潜血检查，与不筛查相比。筛查结果阳性的患者接受结肠镜检查。
测量指标
按性别分层的年龄调整 CRC 发病率和死亡率。
结果
在 98678 人中，20552 人被随机分配至筛查组，78126 人分配至非筛查组。女性的依从率为 64.7%，男性为 61.4%。中位随访时间为 14.8 年。女性 CRC 的绝对风险在筛查组为 1.86%，在对照组为 2.05%（风险差异，-0.19 个百分点[95%CI，-0.49 至 0.11 个百分点]；HR，0.92[CI，0.79 至 1.07]）。在男性中，相应的风险分别为 1.72%和 2.50%（风险差异，-0.78 个百分点[CI，-1.08 至 -0.48 个百分点]；风险比[HR]，0.66[CI，0.57 至 0.78]）（P 异质性=0.004）。女性 CRC 死亡的绝对风险在筛查组为 0.60%，在对照组为 0.59%（风险差异，0.01 个百分点[CI，-0.16 至 0.18 个百分点]；HR，1.01[CI，0.77 至 1.33]）。男性 CRC 死亡的相应风险分别为 0.49%和 0.81%（风险差异，-0.33 个百分点[CI，-0.49 至 -0.16 个百分点]；HR，0.63[CI，0.47 至 0.83]）（P 异质性=0.014）。
局限性
通过国家登记处进行随访。
结论
在挪威提供乙状结肠镜筛查可降低男性 CRC 的发病率和死亡率，但对女性的影响较小或没有影响。
主要资金来源
挪威政府和挪威癌症协会。
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