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比较1升和2升聚乙二醇与抗坏血酸用于小肠胶囊内镜检查:一项随机对照试验。

Comparing 1-L and 2-L Polyethylene Glycol with Ascorbic Acid for Small Bowel Capsule Endoscopy: A Randomized Controlled Trial.

作者信息

Oh Chang Kyo, Lee Sang Pyo, Lee Jae Gon, Yang Young Joo, Seo Seung In, Bang Chang Seok, Kim Yu Jin, Shin Woon Geon, Kim Jin Bae, Jang Hyun Joo, Kae Sea Hyub, Baik Gwang Ho

机构信息

Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.

Institute for Liver and Digestive Diseases, Hallym University, Chuncheon, Korea.

出版信息

Gut Liver. 2025 Jan 15;19(1):87-94. doi: 10.5009/gnl240216. Epub 2024 Dec 4.

Abstract

BACKGROUND/AIMS: Small bowel capsule endoscopy (SBCE) has become the standard for initial evaluation in the diagnosis of small bowel lesions. Although optimal visualization of the mucosa is important, patients experience difficulty in consuming a large volume of bowel preparation agents. This study aimed to compare the efficacy and safety of 1-L polyethylene glycol (PEG) with ascorbic acid (AA) and 2-L PEG with AA.

METHODS

In this prospective, multicenter, non-inferiority study, patients who received SBCE were randomly assigned to consume 1-L PEG with AA or 2-L PEG with AA for small bowel preparation. The primary outcome was adequate small bowel visibility quality (SBVQ). The secondary outcomes included diagnostic yield, cecal complete rate, and adverse events.

RESULTS

One hundred and forty patients were enrolled in this study, 70 patients per group. In the per-protocol analysis, there were no significant differences in the adequate SBVQ rate (94.0% vs 94.3%; risk difference, -0.3; 95% confidence interval, -8.1 to 7.6; p=1.000), diagnostic yield rate (49.3% vs 48.6%, p=0.936), or cecal complete rate (88.1% vs 92.9%, p=0.338) between the 1-L PEG with AA group and 2-L PEG with AA group. The incidence of adverse events did not differ significantly between the groups (12.9% vs 11.9%, p=0.871).

CONCLUSIONS

One liter-PEG with AA is not inferior to 2-L PEG with AA in terms of adequate SBVQ for SBCE. One liter-PEG with AA can be recommended as the standard method for bowel cleansing for SBCE.

摘要

背景/目的:小肠胶囊内镜检查(SBCE)已成为小肠病变诊断初始评估的标准方法。尽管黏膜的最佳可视化很重要,但患者在服用大量肠道准备剂时会遇到困难。本研究旨在比较1升聚乙二醇(PEG)加抗坏血酸(AA)与2升PEG加AA的疗效和安全性。

方法

在这项前瞻性、多中心、非劣效性研究中,接受SBCE的患者被随机分配服用1升PEG加AA或2升PEG加AA进行小肠准备。主要结局是足够的小肠可视质量(SBVQ)。次要结局包括诊断率、盲肠完成率和不良事件。

结果

本研究共纳入140例患者,每组70例。在符合方案分析中,1升PEG加AA组和2升PEG加AA组在足够的SBVQ率(94.0%对94.3%;风险差异,-0.3;95%置信区间,-8.1至7.6;p = 1.000)、诊断率(49.3%对48.6%,p = 0.936)或盲肠完成率(88.1%对92.9%,p = 0.338)方面无显著差异。两组不良事件的发生率无显著差异(12.9%对11.9%,p = 0.871)。

结论

就SBCE的足够SBVQ而言,1升PEG加AA并不劣于2升PEG加AA。1升PEG加AA可被推荐为SBCE肠道清洁的标准方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9995/11736315/55a2db48297c/gnl-19-1-87-f1.jpg

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