Panda Kalpana, Prusty J Bikrant Kumar, Dash Mrutunjay, Biswal Basudev, Mohanty Mamata Devi, Saboth Prasant Kumar
Division of Pediatric Gastroenterology and Hepatology, Department of Pediatric, Institute of Medical Sciences and SUM Hospital, Bhubaneswar, Odisha, India.
Department of Pediatric, Institute of Medical Sciences and SUM Hospital, Bhubaneswar, Odisha, India.
Pediatr Gastroenterol Hepatol Nutr. 2025 Jul;28(4):233-244. doi: 10.5223/pghn.2025.28.4.233. Epub 2025 Jul 7.
Polyethylene glycol (PEG) is recommended as the first-line laxative for fecal disimpaction in pediatric functional constipation. PEG 3350+electrolyte (E) and PEG 4000 are the most commonly available formulations. PEG 3350+E and PEG 4000 have hypothesized benefits of lower risk of electrolyte imbalance and better palatability, respectively. However, a head-to-head comparison of these two formulations for fecal disimpaction remains lacking. This study aimed to compare the efficacy, tolerability, and acceptability of PEG 3350+E vs. PEG 4000 for fecal disimpaction in pediatric functional constipation.
This double-blind, randomized controlled intention-to-treat trial included pediatric patients with functional constipation (as per ROME IV) and fecal impaction. Patients with organic constipation, h/o prior to gastrointestinal surgery, and those who were already receiving PEG/lactulose were excluded. Computer-generated block randomization was performed. Colorless liquid formulations of study medication were provided by investigator (JBK) as per treatment allocation in identical opaque bottles @1.5 gm/kg/dayx6 days or until fecal impaction resolution (passage of clear liquid stool), whichever is earlier.
One hundred patients were randomized in a 1:1 ratio (50 patients in each arm). Efficacy of PEG 3350+E vs. PEG 4000 was similar (84% vs. 86%; =0.9). Similarly, no significant differences were noted in the adverse event rates between two groups. Abdominal discomfort and vomiting were the most common adverse effects. PEG 4000 showed better palatability than PEG 3350+E (=0.044). However, there was no significant difference in the compliance rate.
PEG 3350+E and PEG 4000 showed similar efficacies for fecal disimpaction, with minor side effects. PEG 4000 had better palatability; however, both were well tolerated by children.
聚乙二醇（PEG）被推荐作为小儿功能性便秘粪便嵌塞的一线泻药。PEG 3350+电解质（E）和PEG 4000是最常用的制剂。PEG 3350+E和PEG 4000分别具有降低电解质失衡风险和更好口感的假定益处。然而，这两种制剂在粪便嵌塞方面的直接比较仍然缺乏。本研究旨在比较PEG 3350+E与PEG 4000在小儿功能性便秘粪便嵌塞治疗中的疗效、耐受性和可接受性。
这项双盲、随机对照意向性治疗试验纳入了患有功能性便秘（根据罗马IV标准）和粪便嵌塞的儿科患者。排除患有器质性便秘、有胃肠道手术史以及已经在接受PEG/乳果糖治疗的患者。进行计算机生成的区组随机化。研究药物的无色液体制剂由研究者（JBK）根据治疗分配，以相同的不透明瓶子提供，剂量为1.5克/千克/天，共6天或直至粪便嵌塞解除（排出清亮液体粪便），以较早者为准。
100名患者按1:1比例随机分组（每组50名患者）。PEG 3350+E与PEG 4000的疗效相似（84%对86%；P=0.9）。同样，两组之间的不良事件发生率没有显著差异。腹部不适和呕吐是最常见的不良反应。PEG 4000的口感比PEG 3350+E更好（P=0.044）。然而，依从率没有显著差异。
PEG 3350+E和PEG 4000在粪便嵌塞治疗中显示出相似的疗效且副作用较小。PEG 4000的口感更好；然而，两者儿童耐受性都良好。
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