Lee Yoo Min, Kim Ju Young, Lee Kyung Jae
Department of Pediatrics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea.
Department of Pediatrics, Daejeon Eulji Medical Center, Eulji University, Daejeon, Republic of Korea.
Transl Pediatr. 2025 Feb 28;14(2):252-261. doi: 10.21037/tp-24-436. Epub 2025 Feb 25.
Long-term maintenance of laxatives is crucial for treating functional constipation (FC) in children. This study aimed to compare the success rates of discontinuation based on different drug reduction methods, in order to identify the optimal strategy for discontinuing laxative use.
This open-label randomized controlled trial was conducted from September 2020 to September 2021. Children with FC who had been successfully treated with lactulose for more than three months were included. Patients were randomly assigned to one of two groups: dose reduction or frequency reduction over a three-month period. The primary outcome was the weaning success rate at week 12. Participants were divided into two subgroups based on the pre-weaning lactulose dosage: the low-dose group (≤1.5 g/kg/day) and the high-dose group (>1.5 g/kg/day).
A total of 16 patients were enrolled, with a median age of 43 months and 11 boys. There were no significant differences in baseline characteristics between the two groups. The primary outcome showed no significant difference: 66.7% for dose reduction 57.1%. for frequency reduction. Weaning success rates decreased at week 16 (33.3% 57.1%) and week 24 (33.3% 42.9%) without significant differences. In the subgroup analysis, the high-dose group showed a significantly higher weaning success rate at 12 weeks compared to the low-dose group (81.8% 20%, P=0.04). Other measures, including median defecation frequency, incontinence episodes, stool consistency, painful defecations, and compliance, were also similar between the groups. Patient satisfaction was 77.8% for dose reduction and 57.1% for frequency reduction, with no significant difference.
The method of reducing the dose or frequency of lactulose did not affect the weaning success rate in children with FC. However, a pre-weaning lactulose dose exceeding 1.5 g/kg/day may lead to better outcomes at week 12. Despite gradual reduction over more than 3 months, the weaning success rate remained low, highlighting the importance of careful drug discontinuation and follow-up.
The Clinical Research Information Service of the Korea Center for Disease Control and Prevention (https://cris.nih.go.kr/cris, registration No. KCT0006286).
长期维持使用泻药对于治疗儿童功能性便秘（FC）至关重要。本研究旨在比较基于不同减药方法的停药成功率，以确定停用泻药的最佳策略。
本开放标签随机对照试验于2020年9月至2021年9月进行。纳入了使用乳果糖成功治疗超过三个月的FC患儿。患者被随机分为两组之一：在三个月内减量或减少用药频率。主要结局是第12周的断奶成功率。参与者根据断奶前乳果糖剂量分为两个亚组：低剂量组（≤1.5 g/kg/天）和高剂量组（>1.5 g/kg/天）。
共纳入16例患者，中位年龄43个月，男性11例。两组之间的基线特征无显著差异。主要结局显示无显著差异：减量组为66.7%，减频组为57.1%。在第16周（33.3%对57.1%）和第24周（33.3%对42.9%）断奶成功率下降，但无显著差异。在亚组分析中，高剂量组在12周时的断奶成功率显著高于低剂量组（81.8%对20%，P = 0.04）。两组之间的其他指标，包括排便频率中位数、失禁发作次数、大便稠度、排便疼痛和依从性也相似。减量组的患者满意度为77.8%，减频组为57.1%，无显著差异。
减少乳果糖剂量或频率的方法不影响FC患儿的断奶成功率。然而，断奶前乳果糖剂量超过1.5 g/kg/天可能在第12周产生更好的结果。尽管在超过3个月的时间里逐渐减量，但断奶成功率仍然较低，凸显了谨慎停药和随访的重要性。
韩国疾病控制与预防中心临床研究信息服务中心（https://cris.nih.go.kr/cris，注册号KCT0006286）。
