Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.
Clin Transl Gastroenterol. 2023 Mar 1;14(3):e00532. doi: 10.14309/ctg.0000000000000532.
Polyethylene glycol with ascorbic acid (PEG/Asc) is a well-established bowel preparation solution with guaranteed effectiveness and safety. A new low-volume agent, 1 L-PEG/Asc, has recently been released. This study aimed to compare the bowel cleansing efficacy and safety of 1 L-PEG/Asc and 2 L-PEG/Asc administered to adult outpatients in a split-dose manner.
Outpatients undergoing colonoscopy enrolled in a single-blinded, single-center, noninferiority study conducted between July and October 2021 were randomized in a 1:1 manner to a 1 L-PEG/Asc or 2 L-PEG/Asc group. Bowel cleansing was assessed using the Boston Bowel Preparation Scale (BBPS) and the Harefield Cleansing Scale in intention-to-treat and per-protocol populations.
Two hundred forty participants were randomized and allocated, with 120 patients in the 1 L and 2 L-PEG/Asc groups, respectively. Noninferiority was demonstrated for overall successful bowel cleansing (BBPS: 92.5% vs 90.8%; 95% confidence interval [CI], -0.054 to 0.087) and the high-quality cleansing rate of the right-sided colon (BBPS = 3, 40.0% vs 35.8%; 95% CI, -0.082 to 0.165; Harefield Cleansing Scale ≥3, 50.0% vs 43.3%; 95% CI, -0.060 to 0.194) in the intention-to-treat population. The overall incidence of adverse events was similar in both groups ([82/120] 68.3% vs [72/120] 60.0%; P = 0.178). The tolerability, acceptability, and compliance rates of both regimens were similar, with no significant differences.
Compared with 2 L-PEG/Asc, 1 L-PEG/Asc achieved successful overall bowel cleansing efficacy with high-quality cleansing in the proximal colon and proved its noninferiority. Therefore, 1 L-PEG/Asc is an acceptable alternative bowel cleansing solution.
聚乙二醇联合维生素 C（PEG/Asc）是一种成熟的肠道准备溶液，具有良好的有效性和安全性。一种新的低容量制剂，1 L-PEG/Asc，最近已被推出。本研究旨在比较成人门诊患者应用 1 L-PEG/Asc 和 2 L-PEG/Asc 进行分剂量给药的肠道清洁效果和安全性。
在 2021 年 7 月至 10 月进行的单盲、单中心、非劣效性研究中，入组的门诊患者被随机以 1:1 的比例分配至 1 L-PEG/Asc 组或 2 L-PEG/Asc 组。采用波士顿肠道准备量表（BBPS）和 Harefield 肠道清洁量表在意向治疗和符合方案人群中评估肠道清洁效果。
共纳入 240 名患者并进行随机分组，每组各 120 例患者。总体上，1 L-PEG/Asc 组的肠道清洁成功率与 2 L-PEG/Asc 组相当（BBPS：92.5% vs 90.8%；95%置信区间[CI]，-0.054 至 0.087），且右侧结肠的高质量清洁率也相似（BBPS = 3，40.0% vs 35.8%；95%CI，-0.082 至 0.165；Harefield 肠道清洁量表≥3，50.0% vs 43.3%；95%CI，-0.060 至 0.194）。在意向治疗人群中，两组的不良反应总发生率相似（[82/120] 68.3% vs [72/120] 60.0%；P = 0.178）。两种方案的耐受性、可接受性和依从性率也相似，无显著差异。
与 2 L-PEG/Asc 相比，1 L-PEG/Asc 实现了整体肠道清洁效果的非劣效性，且高质量清洁了近端结肠。因此，1 L-PEG/Asc 是一种可接受的替代肠道清洁溶液。
