Di Nardo Giovanni, Aloi Marina, Cucchiara Salvatore, Spada Cristiano, Hassan Cesare, Civitelli Fortunata, Nuti Federica, Ziparo Chiara, Pession Andrea, Lima Mario, La Torre Giuseppe, Oliva Salvatore
Departments of Pediatrics, Pediatric Gastroenterology Unit, and
Departments of Pediatrics, Pediatric Gastroenterology Unit, and.
Pediatrics. 2014 Aug;134(2):249-56. doi: 10.1542/peds.2014-0131. Epub 2014 Jul 7.
The ideal preparation regimen for pediatric colonoscopy remains elusive, and available preparations continue to represent a challenge for children. The aim of this study was to compare the efficacy, safety, tolerability, and acceptance of 4 methods of bowel cleansing before colonoscopy in children.
This randomized, investigator-blinded, noninferiority trial enrolled all children aged 2 to 18 years undergoing elective colonoscopy in a referral center for pediatric gastroenterology. Patients were randomly assigned to receive polyethylene glycol (PEG) 4000 with simethicon (PEG-ELS group) or PEG-4000 with citrates and simethicone plus bisacodyl (PEG-CS+Bisacodyl group), or PEG 3350 with ascorbic acid (PEG-Asc group), or sodium picosulfate plus magnesium oxide and citric acid (NaPico+MgCit group). Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale. The primary end point was overall colon cleansing. Tolerability, acceptability, and compliance were also evaluated.
Two hundred ninety-nine patients were randomly allocated to the 4 groups. In the per-protocol analysis, PEG-CS+Bisacodyl, PEG-Asc, and NaPico+MgCit were noninferior to PEG-ELS in bowel-cleansing efficacy of both the whole colon (P = .910) and colonic segments. No serious adverse events occurred in any group. Rates of tolerability, acceptability, and compliance were significantly higher in the NaPico+MgCit group.
Low-volume PEG preparations (PEG-CS+Bisacodyl, PEG-Asc) and NaPico+MgCit are noninferior to PEG-ELS in children, representing an attractive alternative to high-volume regimens in clinical practice. Because of the higher tolerability and acceptability profile, NaPico+MgCit would appear as the most suitable regimen for bowel preparation in children.
儿科结肠镜检查的理想准备方案仍不明确,现有的准备方法对儿童来说仍是一项挑战。本研究的目的是比较儿童结肠镜检查前4种肠道清洁方法的疗效、安全性、耐受性和接受度。
本随机、研究者设盲、非劣效性试验纳入了在一家儿科胃肠病转诊中心接受择期结肠镜检查的所有2至18岁儿童。患者被随机分配接受含西甲硅油的聚乙二醇(PEG)4000(PEG-ELS组)或含柠檬酸盐、西甲硅油加比沙可啶的PEG-4000(PEG-CS+比沙可啶组),或含抗坏血酸的PEG 3350(PEG-抗坏血酸组),或匹可硫酸钠加氧化镁和柠檬酸(NaPico+MgCit组)。根据波士顿肠道准备量表评估肠道清洁情况。主要终点是全结肠清洁情况。还评估了耐受性、接受度和依从性。
299例患者被随机分配到4组。在符合方案分析中,PEG-CS+比沙可啶组、PEG-抗坏血酸组和NaPico+MgCit组在全结肠(P = 0.910)和结肠各段的肠道清洁疗效上不劣于PEG-ELS组。任何组均未发生严重不良事件。NaPico+MgCit组的耐受性、接受度和依从率显著更高。
小剂量PEG制剂(PEG-CS+比沙可啶、PEG-抗坏血酸)和NaPico+MgCit在儿童中不劣于PEG-ELS,是临床实践中大容量方案的有吸引力的替代方案。由于具有更高的耐受性和接受度,NaPico+MgCit似乎是儿童肠道准备最合适的方案。