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意大利“单次乙状结肠镜检查”多中心随机对照试验——SCORE的基线研究结果

Baseline findings of the Italian multicenter randomized controlled trial of "once-only sigmoidoscopy"--SCORE.

作者信息

Segnan Nereo, Senore Carlo, Andreoni Bruno, Aste Hugo, Bonelli Luigina, Crosta Cristiano, Ferraris Roberto, Gasperoni Stefano, Penna Angelo, Risio Mauro, Rossini Francesco Paolo, Sciallero Stefania, Zappa Marco, Atkin Wendy S

机构信息

Unit of Epidemiology, Centro per la Prevenzione Oncologica-Piemonte, Azienda Sanitaria Ospedaliero S. Giovanni Batista, Via S Francesco da Paola 31, Piemonte, 10123 Turin, Italy.

出版信息

J Natl Cancer Inst. 2002 Dec 4;94(23):1763-72. doi: 10.1093/jnci/94.23.1763.

DOI:10.1093/jnci/94.23.1763
PMID:12464648
Abstract

BACKGROUND

A single sigmoidoscopy examination at around age 60 years has been proposed as a cost-effective strategy to prevent colorectal cancer. A multicenter randomized controlled trial, the SCORE trial, is in progress in Italy to estimate the impact of this strategy on colorectal cancer incidence and mortality and the duration of the protective effect. We present the baseline screening outcomes.

METHODS

A questionnaire was mailed to a random sample of 236 568 people aged 55-64 years to assess their eligibility for and interest in screening. Those reporting a history of colorectal cancer, adenomas, inflammatory bowel disease, recent colorectal endoscopy, or two first-degree relatives with colorectal cancer were excluded. Eligible, interested respondents were assigned randomly to the control group (no further contact) or the intervention group (invitation to undergo sigmoidoscopy). Screenees with colorectal cancer, polyps larger than 5 mm, three or more adenomas, adenomas 5 mm or smaller with a villous component of more than 20%, or severe dysplasia were referred for colonoscopy.

RESULTS

Of the 56 532 respondents (23.9% of those invited), 34 292 were enrolled and 17 148 were assigned to the screening group. Of those, 9999 attended and 9911 were actually examined by sigmoidoscopy. Distal adenomas were detected in 1070 subjects (10.8%). Proximal adenomas were detected in 116 of 747 (15.5%) subjects without cancer at sigmoidoscopy who then underwent colonoscopy. A total of 54 subjects was found to have colorectal cancer, a rate of 5.4 per 1000 (54% of which were Dukes' A). The procedures were relatively safe, with two perforations (one in 9911 sigmoidoscopy exams and one in 775 colonoscopies) and one hemorrhage requiring hospitalization after polypectomy during colonoscopy. The pain associated with sigmoidoscopy was described as mild or less than expected by 83.3% of the screenees.

CONCLUSION

Sigmoidoscopy screening is generally acceptable to recipients and safe. The high yield of advanced adenomas is consistent with the projected impact of sigmoidoscopy screening on colorectal cancer incidence.

摘要

背景

在60岁左右进行一次乙状结肠镜检查被认为是预防结直肠癌的一种具有成本效益的策略。一项多中心随机对照试验——SCORE试验正在意大利进行,以评估该策略对结直肠癌发病率、死亡率以及保护作用持续时间的影响。我们展示了基线筛查结果。

方法

向236568名年龄在55 - 64岁的随机抽样人群邮寄了一份问卷,以评估他们参与筛查的资格和兴趣。那些报告有结直肠癌、腺瘤、炎症性肠病病史、近期进行过结直肠内镜检查或有两名患结直肠癌的一级亲属的人被排除在外。符合条件且感兴趣的受访者被随机分配到对照组(不再进一步联系)或干预组(邀请接受乙状结肠镜检查)。患有结直肠癌、息肉大于5毫米、三个或更多腺瘤、5毫米或更小且绒毛成分超过20%的腺瘤或严重发育异常的受检者被转诊进行结肠镜检查。

结果

在56532名受访者中(占受邀者的23.9%),34292人被纳入研究,其中17148人被分配到筛查组。在这些人中,9999人参加了检查,9911人实际接受了乙状结肠镜检查。在1070名受试者(10.8%)中检测到远端腺瘤。在747名乙状结肠镜检查时未患癌症且随后接受结肠镜检查的受试者中,有116人(15.5%)检测到近端腺瘤。总共发现54名受试者患有结直肠癌,发病率为每1000人中有5.4人(其中54%为Dukes' A期)。这些检查相对安全,有两例穿孔(9911次乙状结肠镜检查中有1例,775次结肠镜检查中有1例),还有1例在结肠镜检查息肉切除术后因出血需要住院治疗。83.3%的受检者表示与乙状结肠镜检查相关的疼痛为轻度或低于预期。

结论

乙状结肠镜检查筛查一般为受检者所接受且安全。晚期腺瘤的高检出率与乙状结肠镜检查筛查对结直肠癌发病率的预期影响一致。

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