Gimeno-García Antonio Z, Hernandez Goretti, Aldea Ana, Nicolás-Pérez David, Jiménez Alejandro, Carrillo Marta, Felipe Vanesa, Alarcón-Fernández Onofre, Hernandez-Guerra Manuel, Romero Rafael, Alonso Inmaculada, Gonzalez Yanira, Adrian Zaida, Moreno Miguel, Ramos Laura, Quintero Enrique
Departamento de Medicina Interna, Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) &Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, La Laguna, Spain.
Unidad de Ensayos Clínicos, Hospital Universitario de Canarias.
Am J Gastroenterol. 2017 Jun;112(6):951-958. doi: 10.1038/ajg.2017.53. Epub 2017 Mar 14.
Inadequate bowel cleansing is a major burden for endoscopy units. The aim of this study was to compare two intensive bowel cleansing regimens in patients with previous colonoscopy with inadequate bowel preparation.
Patients with inadequate cleansing at index colonoscopy were randomized to 4-L split-dose polyethylene-glycol (PEG) regimen vs. 2-L split-dose PEG plus ascorbic acid (PEG+Asc) regimen. All individuals underwent a 3-day low-residue diet and received 10 mg of bisacodyl, the day before colonoscopy. Cleansing was considered to be adequate if the Boston Bowel Preparation Scale scored ≥2 at each colonic segment. A non-inferiority analysis was performed to demonstrate that colonic cleansing with 2-L PEG+Asc was not inferior to 4-l PEG, considering a non-inferiority margin of 10%.
Adequate bowel cleansing was significantly higher in patients assigned to 4-L PEG regimen (n=127) vs. those randomized to 2-L PEG+Asc regimen (n=129) by intention-to-treat analysis (81.1 vs. 67.4%, odds ratio (OR) 2.07, 95% confidence interval (CI) (1.163-3.689)) and by per-protocol analysis (86.6 vs. 71.7%, OR: 2.55, 95% CI: (1.316-4.922)). The study was terminated for futility after the interim analysis, because the 95% CI of the difference of proportions was 3.13-24.27% in the intention-to-treat analysis and 3.33-26.47% in the per-protocol analysis, confirming the superiority of 4-L PEG preparation.
After 3-day low-residue diet and oral bisacodyl before colonoscopy, colon cleansing with 4-L split-dose PEG was superior to 2-L split-dose PEG+Asc in patients with previous inadequate cleansing. (EUDRACT: 2013-002506-31, NCT02073552).
肠道准备不充分是内镜检查科室的一项主要负担。本研究的目的是比较两种强化肠道准备方案在既往结肠镜检查肠道准备不充分患者中的效果。
在初次结肠镜检查时肠道准备不充分的患者被随机分为4升分次服用聚乙二醇（PEG）方案组和2升分次服用PEG加抗坏血酸（PEG+Asc）方案组。所有患者在结肠镜检查前3天接受低渣饮食，并服用10毫克比沙可啶。如果波士顿肠道准备量表在每个结肠段的评分≥2分，则认为肠道准备充分。进行非劣效性分析以证明2升PEG+Asc方案的结肠清洁效果不劣于4升PEG方案，非劣效界值为10%。
在意向性分析中，分配到4升PEG方案组（n=127）的患者肠道准备充分率显著高于随机分配到2升PEG+Asc方案组（n=129）的患者（81.1%对67.4%，优势比（OR）2.07，95%置信区间（CI）（1.163 - 3.689））；在符合方案分析中也是如此（86.6%对71.7%，OR：2.55，95%CI：（1.316 - 4.922））。中期分析后，该研究因无效而终止，因为在意向性分析中比例差异的95%CI为3.13 - 24.27%，在符合方案分析中为3.33 - 26.47%，证实了4升PEG方案的优越性。
在结肠镜检查前进行3天低渣饮食和口服比沙可啶后，对于既往肠道准备不充分的患者，4升分次服用PEG方案的结肠清洁效果优于2升分次服用PEG+Asc方案（欧盟临床试验注册号：2013 - 002506 - 31，美国国立医学图书馆临床试验注册号：NCT02073552）。
