Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.
Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
J Gastroenterol. 2024 May;59(5):402-410. doi: 10.1007/s00535-024-02089-9. Epub 2024 Mar 16.
We compared the efficacy, tolerability, and safety of oral sulfate tablets (OST, which contains simethicone) and 2 L-polyethylene glycol/ascorbate (2 L-PEG/Asc) with a split-dosing regimen in older individuals aged ≥ 70 years who underwent scheduled colonoscopy.
This prospective, randomized, investigator-blinded, multicenter study was conducted between June 2022 and October 2023. Participants aged ≥ 70 years were randomized at a ratio of 1:1 to the OST or 2 L-PEG/Asc groups.
In total, 254 patients were evaluated using a modified full analysis set. Successful overall bowel preparation was excellent and similar between the OST and 2 L-PEG/Asc groups for the Boston Bowel Preparation Scale (BBPS) (96.5% vs. 96.6%) and Harefield Cleansing Scale (HCS) (96.5% vs. 97.4%). The overall high-quality preparation rate was higher in the OST group than in the 2 L-PEG/Asc group (BBPS: 55.7% vs. 28.4%, P < 0.001; HCS: 66.1% vs. 38.8%, P < 0.001). The overall adenoma detection rate (54.8% vs. 35.3, P = 0.003) was superior in the OST group compared to the 2 L-PEG/Asc group. Tolerability scores, including overall satisfaction, were generally higher in the OST group than in the 2 L-PEG/Asc group. The incidence of major solicited adverse events was comparable between the two groups (55.7% vs. 68.1, P = 0.051), and there were no clinically significant changes in the serum laboratory profiles on the day of or 7 days after colonoscopy.
OST is an effective and safe low-volume agent for colonoscopy, with better tolerance than 2 L-PEG/Asc, in older individuals aged ≥ 70 years.
我们比较了口服硫酸盐片（OST，含二甲硅油）和 2 L-聚乙二醇/抗坏血酸（2 L-PEG/Asc）与分剂量方案在年龄≥70 岁接受计划结肠镜检查的老年人中的疗效、耐受性和安全性。
这是一项前瞻性、随机、研究者设盲、多中心研究，于 2022 年 6 月至 2023 年 10 月进行。年龄≥70 岁的参与者按 1:1 的比例随机分为 OST 或 2 L-PEG/Asc 组。
共有 254 名患者使用改良全分析集进行评估。在波士顿肠道准备量表（BBPS）（96.5%对 96.6%）和 Harefield 清洁量表（HCS）（96.5%对 97.4%）方面，OST 和 2 L-PEG/Asc 组的总体肠道准备效果均良好且相似。OST 组的高质量准备率高于 2 L-PEG/Asc 组（BBPS：55.7%对 28.4%，P<0.001；HCS：66.1%对 38.8%，P<0.001）。OST 组的总体腺瘤检出率（54.8%对 35.3%，P=0.003）优于 2 L-PEG/Asc 组。在总体满意度等方面，OST 组的耐受性评分普遍高于 2 L-PEG/Asc 组。两组主要不良事件发生率相当（55.7%对 68.1%，P=0.051），结肠镜检查当天或 7 天后血清实验室指标无临床显著变化。
OST 是一种有效且安全的低容量肠道准备药物，在年龄≥70 岁的老年人中，其耐受性优于 2 L-PEG/Asc。
