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木葡聚糖和凝胶多糖治疗儿童急性腹泻的随机、安慰剂对照试验。

Randomized, placebo-controlled trial of xyloglucan and gelose for the treatment of acute diarrhea in children.

机构信息

Vall d'Hebron Institut de Recerca (VHIR) , Barcelona, Spain.

Servei de Aparell Digestiu, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus , Barcelona, Spain.

出版信息

Expert Rev Gastroenterol Hepatol. 2021 Mar;15(3):325-331. doi: 10.1080/17474124.2021.1833715. Epub 2020 Oct 19.

DOI:10.1080/17474124.2021.1833715
PMID:33028102
Abstract

BACKGROUND

Oral rehydration is the main treatment of acute diarrhea in children. This study was undertaken to evaluate the efficacy and safety of xyloglucan and gelose (agar-agar) plus oral rehydration solution (ORS) compared with placebo and ORS for reduction of acute diarrhea symptoms in children.

METHODS

In a randomized, double-blind, placebo-controlled trial, children with acute gastroenteritis received xyloglucan/gelose plus ORS (n = 50) or placebo plus ORS (n = 50) for 5 days. Demographic, clinical, anthropometric and laboratory parameters were recorded and analyzed.

RESULTS

Xyloglucan/gelose plus ORS reduced the total number of type 7 and 6 stools on the Bristol Stool Form scale ( = 0.040 and = 0.015, respectively, compared to placebo plus ORS), and had a rapid onset of action, evident 6 hours post-treatment. Xyloglucan/gelose plus ORS also improved associated clinical symptoms (apathy, vomiting, flatulence, and blood in stool). compared with placebo plus ORS. Except for a generalized rash of unknown causality in a patient receiving placebo plus ORS, all other adverse events (dehydration, n = 7, cough, n = 1, exacerbation of vomiting, n = 1) were deemed unrelated to study medication.

CONCLUSIONS

Xyloglucan/gelose plus ORS was effective and safe in treating acute diarrhea in children.

摘要

背景

口服补液是儿童急性腹泻的主要治疗方法。本研究旨在评估木葡聚糖和凝胶(琼脂)与口服补液溶液(ORS)联合应用与安慰剂和 ORS 相比,在减轻儿童急性腹泻症状方面的疗效和安全性。

方法

在一项随机、双盲、安慰剂对照试验中,患有急性胃肠炎的儿童接受木葡聚糖/凝胶与 ORS(n=50)或安慰剂与 ORS(n=50)治疗 5 天。记录和分析人口统计学、临床、人体测量学和实验室参数。

结果

木葡聚糖/凝胶与 ORS 联合治疗可减少布里斯托粪便形态量表上 7 型和 6 型粪便的总数(与安慰剂+ORS 相比,分别为=0.040 和=0.015),且起效迅速,治疗后 6 小时即可显现效果。木葡聚糖/凝胶与 ORS 联合治疗还可改善相关临床症状(乏力、呕吐、腹胀和粪便带血)。与安慰剂+ORS 相比。除了一名接受安慰剂+ORS 治疗的患者出现原因不明的全身性皮疹外,所有其他不良事件(脱水,n=7,咳嗽,n=1,呕吐加重,n=1)均被认为与研究药物无关。

结论

木葡聚糖/凝胶与 ORS 联合治疗儿童急性腹泻是有效且安全的。

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