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乳酸菌对功能性便秘儿童的有效性和安全性:一项荟萃分析与系统评价的研究方案

Effectiveness and safety of lactobacilli in children with functional constipation: Study protocol for a meta-analysis and systematic review.

作者信息

Yang Wenhao, He Tao, Zhang Weijian, Gu Li, Tu Renyuan, Liu Hanmin

机构信息

Department of Pediatrics, West China Second University Hospital, Sichuan University, Guoxuexiang, Chengdu.

Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, Sichuan.

出版信息

Medicine (Baltimore). 2019 May;98(20):e15675. doi: 10.1097/MD.0000000000015675.

Abstract

BACKGROUND

Constipation is one of the most common diseases in children and it is also a significant healthcare burden, more than many other common childhood diseases. For some children, 1st-line treatment cannot relieve their constipation and their constipation symptoms maybe continue to adolescence. So, alternative treatment options such as lactobacilli are needed. However, the effectiveness and safety of lactobacilli is still unclear. To investigate this question, we conduct a systematic review and meta-analysis.

METHODS

The protocol followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Three main databases (PubMed, Embase, and the Cochrane Library) will be searched to December 20, 2018 for randomized controlled trials investigating the effects and safety of lactobacilli for constipation in children with no language restrictions. In addition, a manual search of the references of relevant published studies will also be considered.Two independent reviewers will conduct studies selection, data extraction, and risk of bias assessment. The primary outcome is defecation frequency, treatment success (bowl movement >3 times per week). The 2nd outcome is stool consistency, incidence of abdominal pain, patients using laxatives, and adverse events.

RESULTS

The results will provide useful information about the effect and safety of lactobacilli for constipation in children.

CONCLUSION

The findings of this study will be published in a peer-reviewed journal.

PROSPERO REGISTRATION NUMBER

CRD42019125913.

摘要

背景

便秘是儿童最常见的疾病之一,也是一项重大的医疗负担,比许多其他常见的儿童疾病负担更重。对于一些儿童来说,一线治疗无法缓解他们的便秘,其便秘症状可能会持续到青春期。因此,需要诸如乳酸菌等替代治疗方案。然而,乳酸菌的有效性和安全性仍不明确。为了研究这个问题,我们进行了一项系统评价和荟萃分析。

方法

本方案遵循系统评价和荟萃分析方案的首选报告项目。将检索三个主要数据库(PubMed、Embase和Cochrane图书馆)至2018年12月20日,以查找无语言限制的关于乳酸菌对儿童便秘影响和安全性的随机对照试验。此外,还将考虑对相关已发表研究的参考文献进行手工检索。两名独立的评审员将进行研究选择、数据提取和偏倚风险评估。主要结局是排便频率、治疗成功(每周排便>3次)。次要结局是粪便稠度、腹痛发生率、使用泻药的患者以及不良事件。

结果

结果将提供有关乳酸菌对儿童便秘影响和安全性的有用信息。

结论

本研究结果将发表在同行评审期刊上。

PROSPERO注册号:CRD42019125913。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f18/6531150/db0e642e2a28/medi-98-e15675-g002.jpg

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