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分剂量准备用于结肠镜检查可提高腺瘤检出率:一项在有组织筛查计划中的随机对照试验。

Split-dose preparation for colonoscopy increases adenoma detection rate: a randomised controlled trial in an organised screening programme.

机构信息

Division of Digestive Endoscopy and Gastroenterology, Valduce Hospital, Como, Italy.

Endoscopy Unit, Nuovo Regina Margherita Hospital, Rome, Italy.

出版信息

Gut. 2017 Feb;66(2):270-277. doi: 10.1136/gutjnl-2015-310685. Epub 2015 Dec 9.

Abstract

OBJECTIVE

Although a split regimen of bowel preparation has been associated with higher levels of bowel cleansing, it is still uncertain whether it has a favourable effect on the adenoma detection rate (ADR). The present study was aimed at evaluating whether a split regimen was superior to the traditional 'full-dose, day-before' regimen in terms of ADR.

DESIGN

In a multicentre, randomised, endoscopist-blinded study, 50-69-year-old subjects undergoing first colonoscopy after positive-faecal immunochemical test within an organised colorectal cancer organised screening programmes were 1:1 randomised to receive low-volume 2-L polyethylene glycol (PEG)-ascorbate solution in a 'split-dose' (Split-Dose Group, SDG) or 'day-before' regimen (Day-Before Group, DBG). The primary endpoint was the proportion of subjects with at least one adenoma. Secondary endpoints were the detection rates of advanced adenomas and serrated lesions at per-patient analysis and the total number of lesions.

RESULTS

690 subjects were included in the study. At per-patient analysis, the proportion of subjects with at least one adenoma was significantly higher in the SDG than in the DBG (183/345, 53.0% vs 141/345, 40.9%, relative risk (RR) 1.22, 95% CI 1.03 to 1.46); corresponding figures for advanced adenomas were 26.4% (91/345) versus 20.0% (69/345, RR 1.35, 95% CI 1.06 to 1.73). At per-polyp analysis, the total numbers of both adenomas and advanced adenomas per subject were significantly higher in the SDG (1.15 vs 0.8, p <0.001; 0.36 vs 0.22, p<0.001).

CONCLUSIONS

In an organised screening setting, the adoption of a split regimen resulted into a higher detection rate of clinically relevant neoplastic lesions, thus improving the effectiveness of colonoscopy. Based on such evidence, the adoption of a split regimen for colonoscopy should be strongly recommended.

CLINICAL TRIAL REGISTRATION NUMBER

NCT02178033.

摘要

目的

虽然分剂量肠道准备方案与更高水平的肠道清洁度相关,但仍不确定其对腺瘤检出率(ADR)是否有有利影响。本研究旨在评估分剂量方案与传统的“全剂量、前一天”方案相比,在 ADR 方面是否具有优势。

设计

在一项多中心、随机、内镜医师设盲的研究中,50-69 岁的受试者在阳性粪便免疫化学试验后,在有组织的结直肠癌筛查计划中接受首次结肠镜检查,按 1:1 随机分配接受低容量 2-L 聚乙二醇(PEG)-抗坏血酸溶液的“分剂量”(分剂量组,SDG)或“前一天”方案(前一天组,DBG)。主要终点是至少有一个腺瘤的受试者比例。次要终点是按患者分析的高级腺瘤和锯齿状病变的检出率以及病变总数。

结果

该研究纳入了 690 名受试者。在按患者分析中,SDG 中至少有一个腺瘤的受试者比例明显高于 DBG(183/345,53.0% vs 141/345,40.9%,相对风险(RR)1.22,95%CI 1.03-1.46);高级腺瘤的相应数字分别为 26.4%(91/345)和 20.0%(69/345,RR 1.35,95%CI 1.06-1.73)。在按息肉分析中,SDG 中每个受试者的腺瘤和高级腺瘤总数明显更高(1.15 与 0.8,p<0.001;0.36 与 0.22,p<0.001)。

结论

在有组织的筛查环境中,采用分剂量方案可提高临床相关肿瘤性病变的检出率,从而提高结肠镜检查的有效性。基于这些证据,强烈建议在结肠镜检查中采用分剂量方案。

临床试验注册号

NCT02178033。

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