Department of Internal Medicine, Division of Gastroenterology, College of Medicine, The Catholic University of Korea.
Catholic Photomedicine Research Institute, Seoul, Korea.
J Clin Gastroenterol. 2019 Nov/Dec;53(10):e431-e437. doi: 10.1097/MCG.0000000000001137.
BACKGROUND/AIMS: This study aimed to compare the efficacy and tolerability of an oral sulfate solution (OSS) versus 2 L of polyethylene glycol/ascorbic acid (2L-PEG/Asc) for bowel cleansing before colonoscopy.
A prospective, single-center, single-blinded, noninferiority, randomized, controlled trial was performed. The primary outcome was the rate of successful bowel cleansing, evaluated using the Boston Bowel Preparation Scale (BBPS). Secondary outcomes were examination time, polyp, and adenoma detection rate (PDR and ADR), tolerability, and safety. Ease of use, palatability, intention to reuse, and satisfaction were evaluated using a questionnaire.
A total of 187 participants were randomized to receive either OSS (n=93) or 2L-PEG/Asc (n=94). Successful bowel cleansing was achieved in 86.0% (80/93) of the OSS group, which was noninferior to the 2L-PEG/Asc group (88.3%, 83/94), with a difference of -2.3% by ITT analysis [95% confidence interval (CI) -12.0 to +7.4]. The withdrawal time of the OSS group was significantly shorter than that of the 2L-PEG/Asc group (11.8±5.2 vs. 14.3±8.5; P=0.016). Ease of use, palatability, intention to reuse, and satisfaction were similar between the 2 groups. Adverse events were also similar between the 2 groups. Mucosal erythema (4.3%) and aphthous lesions (2.1%) were found only in the 2L-PEG/Asc group.
OSS was as effective as 2L-PEG/Asc for successful bowel cleansing and had acceptable tolerability. OSS is a promising and safe low-volume preparation alternative for colonoscopy. (Clinical trial registration number: NCT02761213.).
背景/目的：本研究旨在比较口服硫酸盐溶液（OSS）与 2L 聚乙二醇/抗坏血酸（2L-PEG/Asc）用于结肠镜检查前肠道清洁的疗效和耐受性。
进行了一项前瞻性、单中心、单盲、非劣效性、随机、对照试验。主要结局是使用波士顿肠道准备量表（BBPS）评估的肠道清洁成功率。次要结局是检查时间、息肉和腺瘤检出率（PDR 和 ADR）、耐受性和安全性。使用问卷评估易用性、口感、重复使用意向和满意度。
共有 187 名参与者被随机分配接受 OSS（n=93）或 2L-PEG/Asc（n=94）。OSS 组成功清洁肠道的比例为 86.0%（80/93），与 2L-PEG/Asc 组（88.3%，83/94）相当，意向性分析的差异为-2.3%（95%置信区间[CI] -12.0 至 +7.4）。OSS 组的退出时间明显短于 2L-PEG/Asc 组（11.8±5.2 比 14.3±8.5；P=0.016）。两组的易用性、口感、重复使用意向和满意度相似。两组的不良反应也相似。仅在 2L-PEG/Asc 组中发现黏膜红斑（4.3%）和口疮性病变（2.1%）。
OSS 与 2L-PEG/Asc 一样有效，可成功清洁肠道，且具有可接受的耐受性。OSS 是一种有前途且安全的结肠镜检查低容量准备替代方案。（临床试验注册号：NCT02761213）。
