Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
Department of, Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan.
Dig Endosc. 2021 Nov;33(7):1131-1138. doi: 10.1111/den.13930. Epub 2021 Mar 9.
To compare the efficacy and safety of oral sulfate solution administered using the same-day dose and the split-dose regimens with those of polyethylene glycol plus ascorbate solution, used for bowel preparation in Japanese patients undergoing colonoscopy.
This multicenter (n = 13), randomized, active-controlled, colonoscopist- and image evaluator-blinded, noninferiority study with parallel-group comparison recruited 632 patients from December 2018 to June 2019. Of these, 602 patients were divided into the oral sulfate solution same-day dose group (n = 200); oral sulfate solution split-dose group (n = 202); and polyethylene glycol plus ascorbate same-day dose group (n = 200). Differences in the efficacy rates between the polyethylene glycol plus ascorbate group and each oral sulfate solution group were calculated using the asymptotic method. The safety of the oral sulfate solution was evaluated, based on the occurrence of adverse events and reactions.
Both oral sulfate solution protocols were confirmed as noninferior to the polyethylene glycol plus ascorbate protocol for bowel-cleansing. The occurrence of adverse reactions was significantly lower in the oral sulfate solution same-day dose group than in the polyethylene glycol plus ascorbate group (P = 0.010). The occurrence of adverse reactions was not significantly different between the oral sulfate solution split-dose and the polyethylene glycol plus ascorbate group.
Oral sulfate solution is not only safe and efficacious but also not inferior to polyethylene glycol plus ascorbate solution (active control). It could be used for bowel preparation in Japanese patients scheduled for colonoscopy (Clinical trial registration number: NCT03794310).
比较口服硫酸盐溶液在当天剂量和分剂量方案下与聚乙二醇加抗坏血酸溶液用于日本结肠镜检查患者肠道准备的疗效和安全性。
这项多中心（n=13）、随机、阳性对照、盲法（结肠镜检查医生和图像评估者）、非劣效性研究采用平行组比较，于 2018 年 12 月至 2019 年 6 月招募了 632 名患者。其中，602 名患者被分为口服硫酸盐溶液当天剂量组（n=200）；口服硫酸盐溶液分剂量组（n=202）；聚乙二醇加抗坏血酸当天剂量组（n=200）。使用渐近法计算聚乙二醇加抗坏血酸组与每个口服硫酸盐溶液组之间疗效率的差异。根据不良反应和反应的发生情况评估口服硫酸盐溶液的安全性。
两种口服硫酸盐溶液方案均被证实与聚乙二醇加抗坏血酸方案相比在肠道清洁方面非劣效。口服硫酸盐溶液当天剂量组不良反应的发生显著低于聚乙二醇加抗坏血酸组（P=0.010）。口服硫酸盐溶液分剂量组与聚乙二醇加抗坏血酸组不良反应的发生无显著差异。
口服硫酸盐溶液不仅安全有效，而且与聚乙二醇加抗坏血酸溶液（阳性对照）相当。它可用于日本结肠镜检查患者的肠道准备（临床试验注册号：NCT03794310）。
