Pan Peng, Chen Huixin, Wang Tongchang, Liu Kaijun, Tuo Biguang, Wang Rong, Fu Hongyu, Jiang Chunmeng, Chen Lisha, Zhao Qiu, Wang Wen, Chen Weigang, Guo Qiang, Chen Weichang, Li Yanqing, Tian Zibin, Feng Zhijie, Yang Shaoqi, Fan Yi, Luan Fujuan, Chen Youxiang, Li Zhaoshen, Bai Yu
Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.
Department of Gastroenterology, Huizhou Central People's Hospital, Huizhou, China.
Am J Gastroenterol. 2025 May 27. doi: 10.14309/ajg.0000000000003557.
Several studies have investigated the role of linaclotide in bowel preparation; however, dosage and timing still warrant further exploration.
This noninferiority randomized controlled study was performed in 16 medical centers. The eligible subjects were randomly assigned to 3 groups: the Lct + 3 L polyethylene glycol (PEG) group (group A), the 3 L PEG group (group B), or the Lct + 2 L PEG group (group C). The primary outcome was the adequate bowel preparation rate based on the Boston Bowel Preparation Scale. Safety was assessed based on the incidence of adverse reactions.
A total of 1,607 eligible subjects were enrolled, and 1,545 colonoscopy videos were uploaded. In the intention-to-treat analysis, the results of the noninferiority test indicated that the adequate bowel preparation rate in group C (87.58%, 95% confidence interval [CI] 85.08%-90.62%) was neither inferior to that of group A (88.79%, 95% CI 86.11%-91.46%) nor group B (83.99%, 95% CI 80.88%-87.09%). The overall incidence of adverse reactions in group A was higher than that in group C (13.64% vs 8.19%, P = 0.012). There were no significant differences in polyp detection rate ( P = 0.089), adenoma detection rate ( P = 0.776), and bowel preparation completion rate ( P = 0.052).
The adequate bowel preparation rate of the combination of 3-day linaclotide and 2 L PEG was neither inferior to the combination of 3-day linaclotide and 3 L PEG nor 3 L PEG alone in the average-risk population.
多项研究探讨了利那洛肽在肠道准备中的作用；然而，剂量和给药时间仍有待进一步探索。
本非劣效性随机对照研究在16个医学中心进行。符合条件的受试者被随机分为3组：利那洛肽+3L聚乙二醇（PEG）组（A组）、3L PEG组（B组）或利那洛肽+2L PEG组（C组）。主要结局是基于波士顿肠道准备量表的充分肠道准备率。根据不良反应发生率评估安全性。
共纳入1607名符合条件的受试者，上传了1545份结肠镜检查视频。在意向性分析中，非劣效性检验结果表明，C组的充分肠道准备率（87.58%，95%置信区间[CI]85.08%-90.62%）既不低于A组（88.79%，95%CI 86.11%-91.46%）也不低于B组（83.99%，95%CI 80.88%-87.09%）。A组不良反应的总体发生率高于C组（13.64%对8.19%，P=0.012）。息肉检出率（P=0.089）、腺瘤检出率（P=0.776）和肠道准备完成率（P=0.052）无显著差异。
在平均风险人群中，3天利那洛肽与2L PEG联合使用的充分肠道准备率既不低于3天利那洛肽与3L PEG联合使用，也不低于单独使用3L PEG。
