Abstract：
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.
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.
摘要：
背景：我们比较了疗效，耐受性,和口服硫酸盐片剂的安全性(OST，其中包含西甲硅油）和2L-聚乙二醇/抗坏血酸盐（2L-PEG/Asc），并在接受定期结肠镜检查的年龄≥70岁的老年个体中采用分给药方案。
方法：这种前瞻性，随机化，调查员失明，多中心研究于2022年6月至2023年10月进行。年龄≥70岁的参与者以1：1的比例随机分配给OST或2个L-PEG/Asc组。
结果：总计，使用改良的完整分析集评估了254例患者。波士顿肠道准备量表（BBPS）的OST和2L-PEG/Asc组之间成功的整体肠道准备非常出色，相似（96.5％vs.96.6%)和Harefield清洁量表(HCS)(96.5%与97.4%）。OST组的整体高质量制备率高于2L-PEG/Asc组（BBPS：55.7％vs.28.4%,P<0.001；HCS：66.1%vs.38.8%,P<0.001)。整体腺瘤检出率(54.8%vs.35.3，P=0.003）在OST组优于2L-PEG/Asc组。耐受性评分,包括总体满意度，OST组普遍高于2L-PEG/Asc组。两组之间的主要不良事件发生率相当（55.7％vs.68.1,P=0.051),并且在结肠镜检查当天或7天后，血清实验室谱没有临床显着变化。
结论：OST是一种有效且安全的小体积结肠镜检查药物，具有比2L-PEG/Asc更好的耐受性，年龄≥70岁的老年人。
方法：这种前瞻性，随机化，调查员失明，多中心研究于2022年6月至2023年10月进行。年龄≥70岁的参与者以1：1的比例随机分配给OST或2个L-PEG/Asc组。
结果：总计，使用改良的完整分析集评估了254例患者。波士顿肠道准备量表（BBPS）的OST和2L-PEG/Asc组之间成功的整体肠道准备非常出色，相似（96.5％vs.96.6%)和Harefield清洁量表(HCS)(96.5%与97.4%）。OST组的整体高质量制备率高于2L-PEG/Asc组（BBPS：55.7％vs.28.4%,P<0.001；HCS：66.1%vs.38.8%,P<0.001)。整体腺瘤检出率(54.8%vs.35.3，P=0.003）在OST组优于2L-PEG/Asc组。耐受性评分,包括总体满意度，OST组普遍高于2L-PEG/Asc组。两组之间的主要不良事件发生率相当（55.7％vs.68.1,P=0.051),并且在结肠镜检查当天或7天后，血清实验室谱没有临床显着变化。
结论：OST是一种有效且安全的小体积结肠镜检查药物，具有比2L-PEG/Asc更好的耐受性，年龄≥70岁的老年人。
