关于在小儿传染性肠胃炎中使用 "生物制剂 "的最新情况。

IF 2.5 3区 医学 Q3 PHARMACOLOGY & PHARMACY
Expert Opinion on Pharmacotherapy Pub Date : 2024-08-01 Epub Date: 2024-08-06 DOI:10.1080/14656566.2024.2387672
Alicia Wampers, Koen Huysentruyt, Yvan Vandenplas
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引用次数: 0

摘要

简介: .急性肠胃炎(AGE)是肠胃微生物群紊乱的结果。某些益生菌株(鼠李糖乳杆菌、布拉氏酵母菌 CNCM I-745、Limosilactobacillus reuteri (L. reuteri) DSM 17,938、鼠李糖乳杆菌 19070-2 和 L. reuteri 的组合 DSM 12,246)可缩短腹泻的持续时间并减轻其严重程度:相关文献来自 PubMed 和 CINAHL。截至 2021 年的重要综述已汇总成表。搜索了AGE中益生菌、前益生菌、合成益生菌和后益生菌的新证据。后益生菌在产品稳定性方面具有优势,且证据不断积累。但由于研究中的纳入和排除标准、主要和次要终点、生物制剂的类型、剂量、给药时间和持续时间等方面存在差异,因此限制了证据的有效性:专家意见:为 AGE 儿童制定一套核心结果是有益的,因为它的应用将提高现有证据的一致性。绝大多数 "生物制剂 "都注册为食品补充剂。与注册为药物的规定相比,食品补充剂的规定优先考虑安全性,而不是疗效,因此食品补充剂的容忍度要高得多。我们建议,尽管有关食品补充剂的法规只要求提供安全性数据,但在销售产品之前,至少要公布一项与商业化产品有关的随机对照试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
An update on the use of 'biotics' in pediatric infectious gastroenteritis.

Introduction: Acute gastroenteritis (AGE) is the consequence of a disturbed gastro-intestinal microbiome. Certain probiotic strains (Lacticaseibacillus rhamnosus, Saccharomyces boulardii CNCM I-745, Limosilactobacillus reuteri (L. reuteri) DSM 17,938, the combination of L. rhamnosus 19070-2 and L. reuteri DSM 12,246) reduce the duration and severity of diarrhea.

Areas covered: Relevant literature was sourced from PubMed and CINAHL. Important reviews until 2021 were summarized in tables. New evidence for pro-, pre-, syn- and postbiotics in AGE was searched for. Postbiotics offer advantages regarding product stability and show accumulating evidence. Heterogeneity in studies regarding the in- and exclusion criteria, primary and secondary endpoints, type, dose, timing and duration of biotic administration limits the evidence.

Expert opinion: Development of a core outcome set for children with AGE would be beneficial, as its application would increase the homogeneity of the available evidence. The vast majority of the 'biotics' is registered as food supplement. Regulations for food supplements prioritize safety over efficacy, making them considerably more tolerant compared to the regulation for registration as medication. We recommend that at least one randomized controlled trial is published with the commercialized product before marketing the product, despite the fact that legislation regarding food supplements requires only safety data.

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来源期刊
CiteScore
5.60
自引率
3.10%
发文量
163
审稿时长
4-8 weeks
期刊介绍: Expert Opinion on Pharmacotherapy is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles and original papers on newly approved/near to launch compounds mainly of chemical/synthetic origin, providing expert opinion on the likely impact of these new agents on existing pharmacotherapy of specific diseases.
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