单次乙状结肠镜检查在结直肠癌筛查中的应用：意大利随机对照试验——SCORE 的随访结果。
Once-only sigmoidoscopy in colorectal cancer screening: follow-up findings of the Italian Randomized Controlled Trial--SCORE.
机构信息
Centro di Prevenzione Oncologica Piemonte and S. Giovanni University Hospital, Turin, Italy.
出版信息
J Natl Cancer Inst. 2011 Sep 7;103(17):1310-22. doi: 10.1093/jnci/djr284. Epub 2011 Aug 18.
BACKGROUND
A single flexible sigmoidoscopy at around the age of 60 years has been proposed as an effective strategy for colorectal cancer (CRC) screening.
METHODS
We conducted a randomized controlled trial to evaluate the effect of flexible sigmoidoscopy screening on CRC incidence and mortality. A questionnaire to assess the eligibility and interest in screening was mailed to 236,568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56,532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17,148) or the control group (no further contact; n = 17,144), between June 14, 1995, and May 10, 1999. Flexible sigmoidoscopy was performed on 9911 subjects. Intention-to-treat and per-protocol analyses were performed to compare the CRC incidence and mortality rates in the intervention and control groups. Per-protocol analysis was adjusted for noncompliance.
RESULTS
A total of 34,272 subjects (17,136 in each group) were included in the follow-up analysis. The median follow-up period was 10.5 years for incidence and 11.4 years for mortality; 251 subjects were diagnosed with CRC in the intervention group and 306 in the control group. Overall incidence rates in the intervention and control groups were 144.11 and 176.43, respectively, per 100,000 person-years. CRC-related death was noted in 65 subjects in the intervention group and 83 subjects in the control group. Mortality rates in the intervention and control groups were 34.66 and 44.45, respectively, per 100,000 person-years. In the intention-to-treat analysis, the rate of CRC incidence was statistically significantly reduced in the intervention group by 18% (rate ratio [RR] = 0.82, 95% confidence interval [CI] = 0.69 to 0.96), and the mortality rate was non-statistically significantly reduced by 22% (RR = 0.78; 95% CI = 0.56 to 1.08) compared with the control group. In the per-protocol analysis, both CRC incidence and mortality rates were statistically significantly reduced among the screened subjects; CRC incidence was reduced by 31% (RR = 0.69; 95% CI = 0.56 to 0.86) and mortality was reduced by 38% (RR = 0.62; 95% CI = 0.40 to 0.96) compared with the control group.
CONCLUSION
A single flexible sigmoidoscopy screening between ages 55 and 64 years was associated with a substantial reduction of CRC incidence and mortality.
背景
有人提出，60 岁左右进行一次软性乙状结肠镜检查是结直肠癌（CRC）筛查的有效策略。
方法
我们进行了一项随机对照试验，以评估软性乙状结肠镜检查对 CRC 发病率和死亡率的影响。我们向意大利六个试验中心随机抽取的 55-64 岁的 236568 名男性和女性邮寄了一份评估筛查资格和意愿的问卷。在 56532 名应答者中，有兴趣且符合条件的受试者被随机分配到干预组（邀请进行软性乙状结肠镜检查；n=17148）或对照组（无进一步联系；n=17144），分组时间为 1995 年 6 月 14 日至 1999 年 5 月 10 日。对 9911 名受试者进行了软性乙状结肠镜检查。我们进行了意向治疗和方案分析，以比较干预组和对照组的 CRC 发病率和死亡率。方案分析调整了不依从性。
结果
共有 34272 名受试者（每组 17136 名）纳入随访分析。发病率的中位随访时间为 10.5 年，死亡率的中位随访时间为 11.4 年；干预组中有 251 名受试者被诊断为 CRC，对照组中有 306 名。干预组和对照组的 CRC 发病率分别为每 100000 人年 144.11 和 176.43，CRC 相关死亡分别为 65 例和 83 例。干预组和对照组的死亡率分别为每 100000 人年 34.66 和 44.45。意向治疗分析显示，干预组 CRC 发病率降低了 18%（RR=0.82，95%CI=0.69-0.96），且死亡率降低了 22%（RR=0.78；95%CI=0.56-1.08），与对照组相比具有统计学意义。在方案分析中，筛查组的 CRC 发病率和死亡率均有统计学意义降低；CRC 发病率降低 31%（RR=0.69；95%CI=0.56-0.86），死亡率降低 38%（RR=0.62；95%CI=0.40-0.96）。
结论
55-64 岁之间进行单次软性乙状结肠镜筛查可显著降低 CRC 的发病率和死亡率。
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