Long-term effects of colonoscopy screening on colorectal cancer incidence and mortality: a multicountry, population-based randomised controlled trial.

Here, we report the effects after 13 years of follow-up.

在这里，我们报告了随访13年后的效果。

Methods

In this multicountry, population-based randomised controlled trial, 84 583 men and women aged 55-64 years at enrolment from Norway, Poland, and Sweden were randomly allocated (1:2) to colonoscopy screening or no screening and analysed.

在这项多国、基于人群的随机对照试验中，共有来自挪威、波兰和瑞典的84,583名年龄在55-64岁之间的男性和女性被随机分配（1:2）接受结肠镜筛查或不接受筛查，并进行了分析。

The primary outcomes were colorectal cancer incidenceand mortality after 10-15 years of follow-up in intention-to-screen analyses, with first analysis after 10 years, and repeated every other year or at longer intervals.

主要结果是在10-15年的随访后，对意向筛查分析中的结直肠癌发病率和死亡率进行评估，首次分析在10年后进行，并每隔一年或更长时间重复一次。

This trial is registered with ClinicalTrials.gov, NCT00883792, and is ongoing.

该试验已在ClinicalTrials.gov注册，编号为NCT00883792，并正在进行中。

Results

At 13 years of follow-up, colorectal cancer incidencewas 375 colorectal cancers (1·46%) of 28 217 individuals in the screening group and 912 colorectal cancers (1·80%) of 56 366 individuals in the no-screening group.

在13年的随访期间，筛查组的结直肠癌发病率为28,217人中的375例（1.46%），未筛查组的结直肠癌发病率为56,366人中的912例（1.80%）。

The risk ratio (RR) was 0·81 (95% CI 0·71-0·90) in intention-to-screen analyses and 0·55 (0·33-0·81) in per-protocol analyses.

在意向性筛查分析中，风险比（RR）为0.81（95%置信区间0.71-0.90），而在按方案分析中，风险比为0.55（0.33-0.81）。

The risk for proximal colorectal cancer was 129 (0·51%) in the screening group versus 283 (0·56%) in the no-screening group (RR 0·91 [0·71-1·09]), and the risk for distal colorectal cancer was 224 (0·87%) in the screening group versus 563 (1·11%) in the no-screening group (RR 0·79 [0·65-0·89]; interaction p<0·0001).

筛查组近端结直肠癌的风险为129例（0.51%），而非筛查组为283例（0.56%），风险比为0.91（95%置信区间0.71-1.09）。对于远端结直肠癌，筛查组的风险为224例（0.87%），而非筛查组为563例（1.11%），风险比为0.79（95%置信区间0.65-0.89；交互作用p<0.0001）。

In men, the colorectal cancer risk was 214 (1·69%) of 14 154 in the screening group and 541 (2·19%) of 28 247 in the no-screening group (RR 0·77 [0·64 to -0·88]); in women, the risk was 161 (1·24%) of 14 063 in the screening group versus 371 (1·43%) of 28 119 in the no-screening group (RR 0·87 [0·70 to 1·02]; interaction p<0·0001).

在男性中，结直肠癌的风险在筛查组为14,154人中的214例（1.69%），而在未筛查组为28,247人中的541例（2.19%）（相对风险0.77 [0.64至-0.88]）；在女性中，筛查组的风险为14,063人中的161例（1.24%），而未筛查组为28,119人中的371例（1.43%）（相对风险0.87 [0.70至1.02]；交互作用p<0.0001）。

Colorectal cancer mortality was 106 (0·41%) of 28 217 in the screening group and 236 (0·47%) of 56 366 in the no-screening group (intention-to-screen RR 0·88 [0·68-1·08], per-protocol RR 0·70 [0·26-1·25]).

结直肠癌死亡率在筛查组为28,217人中的106例（0.41%），而在未筛查组为56,366人中的236例（0.47%）（意向性筛查相对风险0.88 [0.68-1.08]，按方案相对风险0.70 [0.26-1.25]）。

The observed colorectal cancer mortality in the non-screening group (0·47%) was substantially lower than expected at the time of designing the trial (0·82%).

在未进行筛查的组别中观察到的结直肠癌死亡率（0.47%）显著低于试验设计时预期的死亡率（0.82%）

interpretation

One colonoscopy significantly reduced colorectal cancer incidencebut not mortality over 13 years.

一次结肠镜检查显著降低了13年内的结直肠癌发病率，但对死亡率没有影响

Colorectal cancer mortality was lower in both study groups than when the trial was designed.

结直肠癌的死亡率在两个研究组中都低于试验设计时的预期。

funding

The Norwegian Research Council, the Nordic Cancer Union, the Norwegian Cancer Society, and the Health Fund of South-East Norway.

挪威研究委员会、北欧癌症联盟、挪威癌症协会以及挪威东南部健康基金。