Division of Gastroenterology, Department of Internal Medicine and Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Center for Crohn's and Colitis, Department of Gastroenterology and Hepatology, Kyung Hee University School of Medicine, Seoul, Korea.
J Gastroenterol Hepatol. 2020 Jan;35(1):29-36. doi: 10.1111/jgh.14826. Epub 2019 Oct 7.
PBK-1701TC is a novel sulfate tablet-based that contains 320 mg of simethicone and delivers 90% of the salt and water delivered by oral sulfate solution (OSS) preparation. This study evaluated the efficacy, safety, and tolerability of PBK-1701TC compared with OSS in bowel preparation for colonoscopy.
This randomized, multicenter, phase 3 non-inferiority trial included adults aged 19 years or older with a body mass index of 19-30 kg/m undergoing colonoscopy at five university hospitals in Korea. The primary efficacy endpoint was successful bowel-cleansing rate, defined as Harefield Cleansing Scale grade A or B as evaluated by blinded central readers. Secondary endpoints included the presence of residual air bubbles. Adverse events and laboratory evaluations were monitored to assess safety. Tolerability was assessed via participant interview.
Overall, 235 participants were randomized, and 224 were included in the per-protocol analysis (PBK, 112; OSS, 112). Successful bowel cleansing was achieved for 95.5% (107/112) in the PBK group, which was non-inferior to the OSS group (98.2%, 110/112) with a difference of -2.7% (one sided 97.5% confidence limit, -8.1%). The participants in the PBK group had fewer intraluminal bubbles (0.9% vs 81.3%, P < 0.001) and reported a lower incidence of nausea and vomiting, with better acceptance, taste, and willingness to repeat the regimen than those in the OSS group (all P < 0.05).
The novel sulfate tablet, PBK-1701TC, was non-inferior to OSS with respect to bowel-cleansing efficacy and exhibited better safety and tolerability in adults undergoing colonoscopy.
PBK-1701TC 是一种新型的硫酸盐片剂，含有 320mg 二甲硅油，可提供口服硫酸盐溶液 (OSS) 制剂输送的 90%的盐和水。本研究评估了 PBK-1701TC 与 OSS 相比在结肠镜检查前肠道准备中的疗效、安全性和耐受性。
这是一项随机、多中心、III 期非劣效性试验，纳入了韩国五所大学医院的年龄在 19 岁及以上、体重指数为 19-30kg/m2 的成年人，这些患者需要接受结肠镜检查。主要疗效终点是由盲法中心读者评估的 Harefield 清洁评分 A 或 B 的成功肠道清洁率。次要终点包括残留气泡的存在。监测不良事件和实验室评估以评估安全性。通过参与者访谈评估耐受性。
共有 235 名参与者被随机分组，224 名参与者纳入意向治疗分析（PBK 组 112 例，OSS 组 112 例）。PBK 组 95.5%（107/112）的患者达到了成功的肠道清洁，非劣效于 OSS 组（98.2%，110/112），差异为-2.7%（单侧 97.5%置信限，-8.1%）。PBK 组的腔内气泡更少（0.9%比 81.3%，P<0.001），报告恶心和呕吐的发生率较低，且接受度、口感和再次使用意愿均优于 OSS 组（均 P<0.05）。
新型硫酸盐片剂 PBK-1701TC 在肠道清洁效果方面不劣于 OSS，在接受结肠镜检查的成年人中表现出更好的安全性和耐受性。
