Background

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.

Methods

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.

Results

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.

Conclusions

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.

中文翻译：

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口服硫酸盐片剂与 2 L-聚乙二醇/抗坏血酸用于老年患者肠道准备的功效、耐受性和安全性：前瞻性、多中心、研究者单盲、随机研究

背景

我们比较了口服硫酸盐片剂（OST，含有西甲硅油）和 2 L-聚乙二醇/抗坏血酸 (2 L-PEG/Asc) 与分次给药方案在年龄 ≥ 70 岁的老年人中的疗效、耐受性和安全性。接受预定的结肠镜检查。

方法

这项前瞻性、随机、研究者盲法、多中心研究于 2022 年 6 月至 2023 年 10 月期间进行。年龄≥ 70 岁的参与者以 1:1 的比例随机分配到 OST 组或 2 个 L-PEG/Asc 组。

结果

总共使用修改后的完整分析集对 254 名患者进行了评估。OST 组和 2 个 L-PEG/Asc 组之间的整体肠道准备非常成功，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%）相似）。OST 组的总体高质量制备率高于 2 L-PEG/Asc 组（BBPS：55.7% vs. 28.4%，P  < 0.001；HCS：66.1% vs. 38.8%，P  < 0.001） 。OST 组的总体腺瘤检出率（54.8% vs. 35.3，P  = 0.003）优于 2 L-PEG/Asc 组。OST 组的耐受性评分（包括总体满意度）普遍高于 2 L-PEG/Asc 组。两组之间主要不良事件的发生率相当（55.7% vs. 68.1，P  = 0.051），并且结肠镜检查当天或后 7 天的血清实验室特征没有临床显着变化。

结论

OST 是一种有效且安全的低容量结肠镜检查试剂，对于 70 岁以上的老年人具有比 2 L-PEG/Asc 更好的耐受性。