Efficacy and safety of oral sodium sulfate solution for bowel preparation before colonoscopy: a phase Ⅲ multi-center randomized controlled trial
10.3760/cma.j.cn321463-20240219-00028
- VernacularTitle:硫酸镁钠钾口服液用于成人结肠镜检查前肠道准备有效性和安全性的Ⅲ期临床多中心随机对照研究
- Author:
Yanhua ZHOU
1
;
Ye ZONG
;
Shu PANG
;
Le XU
;
Zhenyu ZHANG
;
Mei WANG
;
Yongdong WU
Author Information
1. 首都医科大学附属北京友谊医院消化内科 国家消化系统疾病临床医学研究中心，北京 100050
- Keywords:
Colonoscopy;
Magnesium sulfate;
Polidocanol;
Efficiency;
Safety;
Bowel preparation
- From:
Chinese Journal of Digestive Endoscopy
2024;41(5):359-365
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of oral sulfate solution (OSS) for bowel preparation.Methods:A multi-center, randomized, single-blinded, positive-controlled and non-inferiority clinical study was conducted. Participants were randomized to receive two bottles of OSS or 4-liter polyethylene glycol (Ⅲ) (PEG) regimen. The primary indicator was efficacy for bowel preparation. Boston bowel preparation scale (BBPS) ≥2 scores in each segment was determined as effective. Secondary endpoints included subjects' compliance, colonoscopy bubble evaluation, time interval of defecation after medication, time interval of defecation type Ⅶ (Bristol stool classification), the number of defecation, and the positive rate of colonoscopy (detection rate of polyps, non-polyp eminence, ulcers, etc.) were also recorded. The safety was evaluated by the incidence of adverse events and severe adverse events.Results:A total of 240 subjects from 4 hospitals were enrolled in the study, with 120 subjects in the experimental group (the OSS group) and 120 subjects in the control group (the PEG group). The full analysis set (FAS) showed that the bowel preparation success rates were 92.44% (110/119) in the OSS group and 91.60% (109/119) in the PEG group ( χ2=0.058, P=0.809) . The total BBPS score and the scores of each bowel segment were all higher in the OSS group than those in the PEG group ( P<0.05) in both FAS and per protocol set (PPS) except the score of left colon in the FAS. The satisfaction rate of bubble evaluation in the OSS group was higher ( 95.80% VS 89.08%, P=0.025). The compliance, positive rate of colonoscopy and safety of the two groups were comparable. Conclusion:Compared with 4-liter PEG regimen, OSS regimen shows similar bowel preparation quality, superior anti-foaming effect with acceptable safety.
