Jung Yunho, Kim Hyun Gun, Yang Dong-Hoon, Kang Hyoun Woo, Park Jae Jun, Baek Dong Hoon, Chun Jaeyoung, Gweon Tae-Geun, Goong Hyeon Jeong, Kwak Min Seob, Lee Hyun Jung, Park Soo-Kyung, Lee Jong Hoon
Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.
Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
J Korean Med Sci. 2024 Dec 16;39(48):e301. doi: 10.3346/jkms.2024.39.e301.
Oral sulfate tablets (OSTs) are bowel preparation agents that combine oral sulfate solution and simethicone. This study compared the efficacy, tolerability, and safety of OST compared to 2 L-polyethylene glycol plus ascorbic acid (2 L-PEG/ASC).
This prospective, randomized, controlled, single-blinded, multicenter, noninferiority trial enrolled 211 healthy adults who underwent colonoscopy between May 2020 and September 2022 at 13 university hospitals. The bowel cleansing rate was assessed using the Boston Bowel Preparation Scale (BBPS) and Harefield Cleansing Scale (HCS), and the preparation agents were administered in split regimens.
The total BBPS score (8.2 ± 1.5 vs. 7.8 ± 1.4, = 0.040) and the high-quality bowel cleansing rates in the right colon (73.2% vs. 50.5), transverse colon (80.6% vs. 68.0%), and left colon (81.5% vs. 67.0%) on the BBPS were significantly higher in the OST group than in the 2 L-PEG/ASC group. However, the rates of successful cleansing according to BBPS (90.7% vs. 91.2%) and HCS (96.3% vs. 94.2%) did not significantly differ between the two groups. The taste, ease, and amount of consumption of the preparation agent; and willingness to repeat colonoscopy with the same agent (89.8% vs. 78.6%, = 0.026) were significantly better in the OST group compared to the 2 L-PEG/ASC group. Adverse events and clinically significant laboratory changes were not significantly different between the two groups.
The OST was not inferior to 2 L-PEG/ASC in terms of bowel cleansing efficacy and showed better tolerability when used for bowel preparation for colonoscopy.
Clinical Research Information Service Identifier: KCT0005017.
口服硫酸片剂（OSTs）是一种将口服硫酸盐溶液和西甲硅油结合的肠道准备剂。本研究比较了OST与2升聚乙二醇加抗坏血酸（2 L-PEG/ASC）的疗效、耐受性和安全性。
这项前瞻性、随机、对照、单盲、多中心、非劣效性试验纳入了2020年5月至2022年9月期间在13家大学医院接受结肠镜检查的211名健康成年人。使用波士顿肠道准备量表（BBPS）和哈雷菲尔德清洁量表（HCS）评估肠道清洁率，且准备剂采用分阶段给药方案。
在BBPS上，OST组的总BBPS评分（8.2±1.5 vs. 7.8±1.4，P = 0.040）以及右半结肠（73.2% vs. 50.5%）、横结肠（80.6% vs. 68.0%）和左半结肠（81.5% vs. 67.0%）的高质量肠道清洁率均显著高于2 L-PEG/ASC组。然而，两组根据BBPS（90.7% vs. 91.2%）和HCS（96.3% vs. 94.2%）的成功清洁率无显著差异。与2 L-PEG/ASC组相比，OST组准备剂的味道、服用便利性和服用量；以及愿意使用相同制剂再次进行结肠镜检查的比例（89.8% vs. 78.6%，P = 0.026）均显著更好。两组之间的不良事件和具有临床意义的实验室变化无显著差异。
在肠道清洁疗效方面，OST不劣于2 L-PEG/ASC，且在用于结肠镜检查的肠道准备时显示出更好的耐受性。
临床研究信息服务标识符：KCT0005017。
