HC Andersen Children's Hospital, Odense University Hospital, Odense.
Department of Pediatrics, Hospital Lillebaelt, Kolding, Denmark.
J Pediatr Gastroenterol Nutr. 2018 Dec;67(6):732-737. doi: 10.1097/MPG.0000000000002070.
The aim of this study was to investigate the long-term efficacy of polyethylene glycol (PEG) during maintenance treatment of childhood functional constipation (FC) in a randomized, double-blinded, placebo-controlled trial.
Children (2-16 years) with FC according to the Rome III criteria were randomly assigned to maintenance treatment with PEG or placebo for 24 weeks. Children reporting treatment failure before 24 weeks were switched to conventional treatment. Primary outcome was successful treatment, defined as absence of any Rome III criteria with or without use of medication after 24 weeks.
A total of 102 children were included: PEG/placebo: 49/53. At 24 weeks, significantly more patients in the PEG group, compared to the placebo group, were successfully treated (33 [67%] vs 19 [36%] hazard ratio (95% confidence intervals) = 3.21 [1.73-5.94]). Significantly fewer children in the PEG group switched to rescue medication (2 [4%] vs 30 [57%], P < 0.001). Time before the change to rescue medication was 13 and 27 days, respectively, for each of the 2 children in the PEG group who required rescue medication. Median time to shift to rescue medication was 27 days (range: 3-64 days) in the placebo group. At 24 weeks after initiation of treatment, 33 children (67%) in the PEG group were successfully treated, compared to 19 children (32%) in the placebo group (hazard ratio (95% confidence intervals) = 3.21 [1.73-5.94]). No serious adverse event related to use of the medication was registered.
Maintenance treatment with PEG is significantly more effective than placebo in preventing relapse of constipation symptoms during long-term maintenance treatment in childhood FC. We therefore recommend that maintenance treatment commence after disimpaction.
本研究旨在通过随机、双盲、安慰剂对照试验，探究聚乙二醇（PEG）在儿童功能性便秘（FC）维持治疗中的长期疗效。
根据罗马 III 标准，将 FC 患儿（2-16 岁）随机分为 PEG 或安慰剂维持治疗 24 周。24 周前报告治疗失败的患儿改用常规治疗。主要结局为 24 周后无任何罗马 III 标准且无需用药的治疗成功。
共纳入 102 例患儿：PEG/安慰剂组分别为 49/53 例。24 周时，PEG 组治疗成功的患儿明显多于安慰剂组（33 [67%] vs 19 [36%]，危险比（95%置信区间）=3.21 [1.73-5.94]）。PEG 组转用解救药物的患儿明显较少（2 [4%] vs 30 [57%]，P < 0.001）。PEG 组需要解救药物的 2 例患儿分别在第 13 和 27 天转用解救药物。安慰剂组中需要解救药物的患儿分别在第 3、27、42、51、64 天转用解救药物。治疗开始后 24 周，PEG 组 33 例（67%）患儿治疗成功，安慰剂组 19 例（32%）患儿治疗成功（危险比（95%置信区间）=3.21 [1.73-5.94]）。未记录到与药物使用相关的严重不良事件。
PEG 维持治疗在预防儿童 FC 长期维持治疗中便秘症状复发方面明显优于安慰剂。因此，我们建议在解除便秘后开始维持治疗。
