Nam Seung-Joo, Park Sung Chul, Lee Sung Joon, Lee Sang Hoon, Kim Ji Hyun, Bang Chang Seok, Seo Hyun Il
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea.
Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea.
J Gastroenterol Hepatol. 2022 Feb;37(2):319-326. doi: 10.1111/jgh.15696. Epub 2021 Oct 5.
The efficacy and safety of the recently introduced low-volume purgatives in elderly people are not well known. Therefore, in this trial, we aimed to evaluate and compare the efficacy of two low-volume agents, oral sulfate solution (OSS) and 2-L polyethylene glycol with ascorbic acid (PEG-Asc), in elderly people.
A prospective, randomized, single-blinded, multicenter, non-inferiority trial was performed at three university-affiliated hospitals in South Korea. Outpatients aged 65-80 years, who underwent elective colonoscopy, were enrolled. The primary outcome was the rate of adequate bowel preparation assessed using the Boston Bowel Preparation Scale.
A total of 199 subjects were randomized into the OSS (n = 99) or the 2-L PEG-Asc (n = 100) group. Of them, 189 subjects were included in the analysis of the primary outcome (OSS group 95 vs PEG-Asc group 94). The proportion of adequate bowel preparation was 89.5% (85/95) in the OSS group and 93.6% (88/94) in the 2-L PEG-Asc group. OSS was not inferior to 2-L PEG-Asc according to the prespecified non-inferiority margin of -15% (95% confidence interval for the difference, -12.1 to 3.8). Vomiting (11.6% vs 2.1%) and thirst (24.2% vs 11.7%) were more common in the OSS group than in the 2-L PEG-Asc group.
OSS is an effective low-volume purgative that is non-inferior to 2-L PEG-Asc in elderly people. Both the low-volume agents were identified to be well tolerated and safe in the healthy elderly population.
近期推出的低容量泻药在老年人中的疗效和安全性尚不清楚。因此，在本试验中，我们旨在评估和比较两种低容量制剂，口服硫酸盐溶液（OSS）和含抗坏血酸的2升聚乙二醇（PEG-Asc）在老年人中的疗效。
在韩国的三所大学附属医院进行了一项前瞻性、随机、单盲、多中心、非劣效性试验。纳入年龄在65 - 80岁、接受择期结肠镜检查的门诊患者。主要结局是使用波士顿肠道准备量表评估的充分肠道准备率。
总共199名受试者被随机分为OSS组（n = 99）或2升PEG-Asc组（n = 100）。其中，189名受试者纳入主要结局分析（OSS组95例，PEG-Asc组94例）。OSS组充分肠道准备的比例为89.5%（85/95），2升PEG-Asc组为93.6%（88/94）。根据预先设定的非劣效性界值-15%，OSS不劣于2升PEG-Asc（差异的95%置信区间为-12.1至3.8）。OSS组呕吐（11.6%对2.1%）和口渴（24.2%对11.7%）比2升PEG-Asc组更常见。
OSS是一种有效的低容量泻药，在老年人中不劣于2升PEG-Asc。两种低容量制剂在健康老年人群中耐受性良好且安全。
