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酸枣仁糖浆与聚乙二醇治疗儿童功能性便秘的比较:一项随机临床试验

Comparison of Ziziphus jujube Mill. Syrup versus polyethylene glycol in children with functional constipation: a randomized clinical trial.

作者信息

Keihanian Fatemeh, Maleknejad Shohreh, Saeidinia Amin, Soltanipour Soheil, Pirooz Amir

机构信息

Guilan Road Trauma Research Center, Trauma Institute, Guilan University of Medical Sciences, Rasht, Iran.

Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.

出版信息

Sci Rep. 2025 Jan 11;15(1):1674. doi: 10.1038/s41598-025-85801-w.

Abstract

Functional constipation is a common disorder of the gastrointestinal tract in children without specific treatment. Ziziphus jujuba has been used in traditional medicine for various diseases such as constipation. A safe and inexpensive treatment with few side effects can be used as an effective alternative to current medications. In this study, we sought to compare Ziziphus jujuba syrup (ZS) with polyethylene glycol (PEG) for the treatment of pediatric functional constipation. A double-blind, randomized clinical trial was performed on children aged 2-10 years with functional constipation who were referred to the gastroenterology clinic of the 17-Shahrivar Hospital in Rasht, Iran. Eligible patients were randomized into two groups: PEG group; 1-5 cc/kg/day (40% w/v solution without electrolytes; average dose: 0.2-1 g/kg), and ZS group; 1-5 cc/kg/day (average dose: 5-25 mg/kg). All patients were followed up for three months, every 2 weeks in the first month, and then monthly for 2 months. At the beginning and end of the study, liver and kidney function tests and blood sugar levels were checked. Data were analyzed using SPSS software version 19 at a significance level of 0.05. Out of 90 eligible children, 32 patients in the PEG group and 30 patients in the ZS group completed the follow-up visits. The mean age of the subjects was 4.31 ± 1.97 years. There was no significant difference between the two groups in terms of age (P = 0.181), gender (P = 0.218), age at onset of constipation (P = 0.083), and weight (P = 0.199). The average therapeutic response score in the ZS group improved prominently compared to the PEG group (P < 0.05). The average number of encopresis and visual analog scale pain scores significantly decreased in the ZS group compared to the PEG group (P < 0.05). Other indices, including frequency of defecation, and medication adherence in the ZS group were significantly improved compared to the PEG group (P < 0.05). Only in the PEG group, a few cases reported self-limiting side effects. ZS can be a treatment choice for functional constipation without any adverse events or liver or kidney injury in children. However, further studies are necessary to find potential side effects.

摘要

功能性便秘是儿童常见的胃肠道疾病,尚无特效治疗方法。枣在传统医学中已被用于治疗多种疾病,如便秘。一种安全、廉价且副作用少的治疗方法可作为当前药物的有效替代品。在本研究中,我们旨在比较枣糖浆(ZS)与聚乙二醇(PEG)治疗小儿功能性便秘的效果。对转诊至伊朗拉什特市17 - 沙希里瓦尔医院胃肠病科的2 - 10岁功能性便秘儿童进行了一项双盲、随机临床试验。符合条件的患者被随机分为两组:PEG组,1 - 5 cc/kg/天(40% w/v无电解质溶液;平均剂量:0.2 - 1 g/kg);ZS组,1 - 5 cc/kg/天(平均剂量:5 - 25 mg/kg)。所有患者随访3个月,第1个月每2周随访1次,后2个月每月随访1次。在研究开始和结束时,检查肝功能、肾功能和血糖水平。使用SPSS 19版软件进行数据分析,显著性水平为0.05。90名符合条件的儿童中,PEG组32例患者和ZS组30例患者完成了随访。受试者的平均年龄为4.31±1.97岁。两组在年龄(P = 0.181)、性别(P = 0.218)、便秘发病年龄(P = 0.083)和体重(P = 0.199)方面无显著差异。与PEG组相比,ZS组的平均治疗反应评分显著改善(P < 0.05)。与PEG组相比,ZS组的大便失禁平均次数和视觉模拟评分疼痛评分显著降低(P < 0.05)。与PEG组相比,ZS组的其他指标,包括排便频率和药物依从性显著改善(P < 0.05)。仅在PEG组,少数病例报告了自限性副作用。ZS可作为儿童功能性便秘的一种治疗选择,且无任何不良事件或肝、肾损伤。然而,有必要进一步研究以发现潜在的副作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c62b/11724880/849f8fdc2b5b/41598_2025_85801_Fig1_HTML.jpg

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