中国循证儿科杂志 ›› 2024, Vol. 19 ›› Issue (4): 267-271.DOI: 10.3969/j.issn.1673-5501.2024.04.002

• 论著 • 上一篇    下一篇

基于病房分组的2岁以上儿童快速或缓慢口服复方聚乙二醇电解质散行肠道准备方案的非随机对照试验

张萍1a,苗士建1a,李萍1a,刘芳1b,施鹏1c,2,唐子斐1a,黄瑛1a   

  1. 1 复旦大学附属儿科医院上海, 201102, a 消化科, b 护理部, c 临床研究中心; 2 复旦大学循证医学中心上海, 200032
  • 收稿日期:2024-09-18 修回日期:2024-09-29 出版日期:2024-08-25 发布日期:2024-10-31
  • 通讯作者: 黄瑛,唐子斐

Efficacy, safety and tolerability of rapid or slow bowel preparation protocol using polyethylene glycol with electrolyte solution before colonoscopy in children over 2 years old: A non-randomized controlled trial

ZHANG Ping1a, MIAO Shijian1a, LI Ping1a, LIU Fang1b, SHI Peng1c,2, TANG Zifei1a, HUANG Ying1a   

  1. 1 Children's Hospital of Fudan University, Shanghai 201102, China, a. Department of Gastroenterology, b. Department of Nursing, c. Clinical Research center, 2 Center for Evidencebased Medicine, Fudan University, Shanghai 200032, China
  • Received:2024-09-18 Revised:2024-09-29 Online:2024-08-25 Published:2024-10-31
  • Contact: HUANG Ying, email: yhuang815@163. com; TANG Zifei,email: zifeitang@fudan. edu. cn

摘要: 背景:既往复方聚乙二醇电解质散(PEGELS)用于儿童肠道准备口服1~4 d方案安全有效, 口服时间长影响儿童上学, 延长住院时间。一些儿童肠道准备快速口服PEGELS方案显示肠道清洁度亦很好。 目的:比较≥2岁儿童电子结肠镜检查(简称镜检)前快速或缓慢口服PEGELS行肠道准备方案的有效性、安全性和耐受性。 设计:非随机对照试验。 方法:纳入2020年8月1日至2021年5月31日在复旦大学附属儿科医院消化科行镜检的患儿, 根据病房分为快速口服组(PEGELSR)和缓慢口服组(PEGELSS)。PEGELSR组于镜检前1天晚上口服2/3剂量PEGELS, 次日早晨口服1/3剂量PEGELS;PEGELSS组于镜检前1天口服, 将PEGELS分为10~12份, 每小时服用1份。镜检医生不知晓分组, 镜检时采用Boston肠道准备量表(BBPS)评估肠道清洁度。并观察2组患儿PEGELS完成率、耐受性和不良事件。 主要结局指标:肠道清洁度。 结果:研究期间315例行镜检患儿进入本研究,主要原因为腹痛待查。平均年龄(9.8±3.2)岁, PEGELSS组153例, PEGELSR组162例。镜检前末次Bristol 评分两组差异无统计学意义。PEGELSR组BBPS评分明显高于PEGELSS组[(8.0±1.3) vs (7.1±1.5), P<0.000 1], PEGELSR组优良率高于PEGELSS组[96.3%(156/162) vs 87.6%(134/153),P=0.004 2], 差异均有统计学意义。两组肠道准备完成率均>90%。PEGELSR组恶心、呕吐、腹痛、腹胀发生率显著高于PEGELSS组。两组患儿均未观察到不良事件。 结论:快速和缓慢口服PEGELS行肠道准备均安全, 快速口服PEGELS的肠道清洁效果优于缓慢口服方案, 但不良反应发生率高于缓慢口服。

关键词: 儿童, 电子结肠镜检查, 肠道准备, 聚乙二醇电解质散

Abstract: Background:Polyethylene glycol with electrolyte solution (PEGELS) is safe and effective for bowel preparation in children. The PEG regimen includes oral administration for 14 days. However, longlasting oral administration may cause inconvenience to children's lives, prolong hospitalization, and affect school attendance. It is observed that the intestinal cleanliness is also good in a rapid oral PEGELS protocol of bowel preparation in some children. Objective:To investigate the efficacy, safety and tolerability of rapid or slow bowel preparation protocol using PEGELS in children over 2 years old. Design:Nonrandomized controlled trial. Methods:The newly diagnosed children in Department of Gastroenterology at Children's Hospital of Fudan University receiving the electronic colonoscopy were enrolled from August 1st, 2020 to May 31st, 2021 according to the inclusion and exclusion criteria. The participants were given PEGELS for the bowel preparation. The participants were nonrandomizedly divided into rapidly oral group (PEGELSR) and slowly oral group (PEGELSS). In the PEGELSR group, 2/3 dose of PEGELS was taken orally from the evening on the day before colonoscopy, and the remaining 1/3 dose of PEGELS was orally administered in the morning of the next day. In the PEGELSS group, PEGELS is given orally on the day before colonoscopy, which is divided into 1012 portions and taken one portion every hour. Bowel cleansing was assessed by Boston bowel preparation scale (BBPS). Compliance with PEGELS, adverse events, and tolerability were observed Main outcome measures:Bowel cleanliness. Results:A total of 315 children were enrolled into the study with the average age of (9.8±3.2) years old, 153 cases in PEGELSS group and 162 cases in PEGELSR group, respectively. There were no significant difference in Bristol stool form score between the two groups before electronic colonoscopy. The main reason for colonoscopy was abdominal pain in both groups. The score of BBPS in PEGELSR group was significantly higher than that in PEGELSS group(8.0±1.3 vs 7.1±1.5, P<0.000 1). The rate of excellence in PEGELSR was higher than that in the PEGELSS group[96.3%(156/162) vs 87.6%(134/153), P<0.000 1]. Both groups of children could complete the dosage of PEGELS well with the completion rate over 90%. The incidence of nausea, vomit, abdominal pain and abdominal distension in PEGELSR group was significantly higher than that in PEGELSS group. There were no adverse events in the two groups. Conclusion:Bowel preparation protocol of PEGELSS and PEGELSR was safe. The bowel cleanliness of PEGELSR regimen is better than that of PEGELSS regimen, but the incidence of adverse reaction of rapid oral PEGELS is higher than that of slow oral administration.

Key words: Child, Electronic colonoscopy, Bowel preparation, Polyethylene glycol with electrolyte solution