METHODS: This single-blinded, randomized, controlled, and multicenter study was conducted from July 2021 to December 2022 at 7 hospitals. Patients with CC who underwent colonoscopies were enrolled and randomly assigned to 4 groups with split-PEG regimens: 4L-PEG group, 4L-PEG+1d-Lin group, 3L-PEG+1d-Lin group, and 3L-PEG+3d-Lin group. The primary outcome was rates of adequate bowel preparation, defined as a total BBPS score ≥6 and a score ≥2 for each segment. Secondary outcomes were adverse effects, sleep quality, willingness to repeat the colonoscopy, adenoma detection rate, and polyp detection rate.
RESULTS: Five hundred two patients were enrolled. The rates of adequate bowel preparation (80.0% vs 60.3%, P < 0.001; 84.4% vs 60.3%, P < 0.001) and the total Boston Bowel Preparation Scale (BBPS) scores (6.90 ± 1.28 vs 6.00 ± 1.61, P < 0.001; 7.03 ± 1.24 vs 6.00 ± 1.61, P < 0.01) in the 4L-PEG+1d-Lin group and the 3L-PEG+3d-Lin group were superior to that in the 4L-PEG group. Compared with the 4L-PEG group, the 4L-PEG+1d-Lin group (66.7% vs 81.7%, P = 0.008) and the 3L-PEG+3d-Lin group (75.0% vs 81.7%, P = 0.224) had a lower percentage of mild adverse events. No statistically significant difference in willingness to repeat the colonoscopy, sleep quality, polyp detection rate, or adenoma detection rate was observed among groups.
CONCLUSIONS: PEG combined with linaclotide might be an effective method for bowel preparation before colonoscopy in patients with CC.
方法:这种单盲,随机化,2021年7月至2022年12月在7家医院进行了对照和多中心研究。纳入接受结肠镜检查的慢性便秘患者,随机分为4组,采用分裂-PEG方案:4L-PEG组,4L-PEG+1d-Lin组,3L-PEG+1d-Lin组,3L-PEG+3d-Lin组。主要结果是充分的肠道准备率,定义为每段BBPS总分≥6分和≥2分。次要结果是不良反应,睡眠质量,愿意重复结肠镜检查,腺瘤检出率,和息肉检出率。
结果:502例患者入选。充分的肠道准备率(80.0%vs.60.3%,P<0.001;84.4%vs.60.3%,P<0.001)和BBPS总分(6.90±1.28vs.6.00±1.61,P<0.001;7.03±1.24vs.6.00±1.61,P<0.01),4L-PEG1d-Lin组和3L-PEG3d-Lin组优于4L-PEG组。与4L-PEG组相比,4L-PEG+1d-Lin组(66.7%vs.81.7%,P=0.008)和3L-PEG+3d-Lin组(75.0%vs.81.7%,P=0.224)的轻度不良事件百分比较低。重复结肠镜检查的意愿无统计学差异,睡眠质量,息肉检出率,观察各组间腺瘤检出率。
结论:PEG联合利那洛肽可能是慢性便秘患者结肠镜检查前肠道准备的有效方法。