PEG 3350 与乳果糖治疗儿童功能性便秘的随机研究。

PEG 3350 Versus Lactulose for Treatment of Functional Constipation in Children: Randomized Study.

机构信息

Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Children's Memorial Health Institute, Warsaw.

Department of Pediatrics, Gastroenterology, Hepatology, Nutrition and Allergology, Medical University of Bialystok.

出版信息

J Pediatr Gastroenterol Nutr. 2019 Mar;68(3):318-324. doi: 10.1097/MPG.0000000000002192.

DOI:10.1097/MPG.0000000000002192

PMID:30383579

Abstract

OBJECTIVES

The aim of this study was to compare the clinical efficacy and tolerance of polyethylene glycol 3350 (PEG) and lactulose for the treatment of functional constipation in infants and children.

METHODS

This randomized, multicenter study covered 12 weeks of treatment and 4 weeks of follow-up of patients with functional constipation. Patients were randomized (central randomization) to receive either PEG or lactulose. The primary end points were the number of defecations per week after 12 weeks of treatment and improvement in stool consistency of at least 2 points in the Bristol scale. The secondary end point was the presence of adverse events. Bowel movements ≥3 per week and stool consistency ≥2 (Bristol scale) were considered as successful treatment.

RESULTS

We enrolled 102 patients (M 57, F 45) aged 3.62 ± 1.42 years and 88 completed the study. At week 12, good clinical outcome was achieved in 98% (PEG) and 90% (lactulose). The PEG group had more defecations per week compared with the lactulose group (7.9 ± 0.6 vs 5.7 ± 0.5, P = 0.008) and both groups had similar frequency of defecation with pain (5% vs 5%, P = 0.9), stool retention (7% vs 10%, P = 057), large volume of stools (30% vs 31%, P = 0.9) and hard stools (7% vs 13%, P = 0.58). There were more patients with side effects in the lactulose group (15 vs 23, P = 0.02), mostly bloating and abdominal pain.

CONCLUSIONS

PEG 3350 is more effective and causes fewer side effects than lactulose in the treatment of constipation in infants and children.

摘要

目的

本研究旨在比较聚乙二醇 3350（PEG）和乳果糖治疗婴儿和儿童功能性便秘的临床疗效和耐受性。

方法

这是一项随机、多中心研究，包括 12 周的治疗和 4 周的随访，共纳入功能性便秘患者。患者按（中央随机）接受 PEG 或乳果糖治疗。主要终点是治疗 12 周后每周排便次数和布里斯托尔大便性状评分至少改善 2 分。次要终点是不良事件的发生情况。每周排便≥3 次且大便性状≥2 分（布里斯托尔大便性状评分）被认为是治疗成功。

结果

共纳入 102 例患者（男 57 例，女 45 例），年龄 3.62±1.42 岁，88 例完成研究。治疗 12 周时，PEG 组和乳果糖组的临床疗效均较好，分别为 98%（PEG）和 90%（乳果糖）。PEG 组每周排便次数多于乳果糖组（7.9±0.6 次 vs 5.7±0.5 次，P=0.008），两组排便时疼痛（5% vs 5%，P=0.9）、大便潴留（7% vs 10%，P=0.57）、大便量多（30% vs 31%，P=0.9）和硬便（7% vs 13%，P=0.58）的频率相似。乳果糖组不良反应发生率高于 PEG 组（15 例 vs 23 例，P=0.02），主要为腹胀和腹痛。