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一项随机、双盲、安慰剂对照交叉先导研究:α-半乳糖苷酶对肠易激综合征患者胃肠道症状的急性影响。

A randomized double-blind placebo-controlled crossover pilot study: Acute effects of the enzyme α-galactosidase on gastrointestinal symptoms in irritable bowel syndrome patients.

机构信息

Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Translational Research Center for Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing (CHROMETA), University of Leuven, Leuven, Belgium.

出版信息

Neurogastroenterol Motil. 2021 Jul;33(7):e14094. doi: 10.1111/nmo.14094. Epub 2021 Feb 22.

Abstract

BACKGROUND

Postprandial symptoms presumably related to intestinal gas production are common in patients with irritable bowel syndrome (IBS). The aim of the study was to assess if oral α-galactosidase is superior to placebo in reducing gastrointestinal (GI) symptoms and intestinal gas production after ingestion of carbohydrate-rich meals in adult patients with IBS.

METHODS

We studied the effect of 1200 GaIU/meal α-galactosidase (Nogasin ) or placebo capsules on GI symptoms in patients with IBS after three standardized, meals high in oligosaccharides, in a randomized, double-blind, crossover study. The intensity of eight GI symptoms was rated, and breath hydrogen and methane were measured every 30 min during 7.5 h. The severity of GI symptoms the following morning was assessed and compared with baseline.

S KEY RESULTS

Twenty adult patients with IBS (19 females), mean age 49 years (range 22-75 years), were included. All test meals were well tolerated but induced a gradual increase in GI symptom severity. Neither GI symptom ratings over time, nor hydrogen and methane concentrations differed between the days with α-galactosidase or placebo. The severity of abdominal pain and bloating was lower the following morning, but with no differences between α-galactosidase and placebo.

CONCLUSIONS & INFERENCES: The use of α-galactosidase together with meals high in oligosaccharides was in this pilot study not superior to placebo in reducing postprandial GI symptoms or the concentration of hydrogen and methane in expired air in IBS.

摘要

背景

餐后胃肠道气体生成相关症状在肠易激综合征(IBS)患者中很常见。本研究旨在评估口服α-半乳糖苷酶是否优于安慰剂,减少成人 IBS 患者摄入富含碳水化合物的餐后胃肠道(GI)症状和肠道气体生成。

方法

我们在一项随机、双盲、交叉研究中,评估了 1200 GaIU/餐的 α-半乳糖苷酶(Nogasin)或安慰剂胶囊对 IBS 患者三种标准化富含低聚糖餐后 GI 症状的影响。使用 8 项 GI 症状强度评分,在 7.5 小时内每 30 分钟测量一次呼气氢和甲烷浓度。评估并比较次日清晨的 GI 症状严重程度与基线时的差异。

结果

共纳入 20 例成年 IBS 患者(19 例女性,平均年龄 49 岁,范围 22-75 岁)。所有测试餐均耐受良好,但逐渐加重 GI 症状严重程度。无论是时间上的 GI 症状评分,还是氢和甲烷浓度,α-半乳糖苷酶和安慰剂之间均无差异。次日清晨腹痛和腹胀的严重程度较低,但α-半乳糖苷酶和安慰剂之间无差异。

结论

在本研究中,与富含低聚糖的膳食一起使用α-半乳糖苷酶在减轻 IBS 患者餐后 GI 症状或呼气中氢和甲烷浓度方面并不优于安慰剂。

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