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小儿推拿治疗早产儿喂养不耐受:系统评价与Meta分析方案

Pediatric Tui Na for Feeding Intolerance in Premature Infants: Protocol for a Systematic Review and Meta-Analysis.

作者信息

Bai Zirong, Lyu Xiaoxiao, Tang Yichuan, Wang Meng

机构信息

Department of Rehabilitation, College of Acupuncture and Moxibustion and Massage Health Preservation and Rehabilitation, Nanjing University of Chinese Medicine, Nanjing, China.

Department of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia.

出版信息

JMIR Res Protoc. 2023 Oct 16;12:e46375. doi: 10.2196/46375.

Abstract

BACKGROUND

Feeding intolerance (FI), frequently resulting from gastrointestinal immaturity, is prevalent among premature infants. Current practices are gradually prioritizing nonpharmacological treatments, such as massage or "Tui na," considering the potential side effects of prolonged medication use. Pediatric Tui na, a specialized massage therapy based on traditional Chinese medicine, has been widely studied for treating FI in premature infants. However, to our knowledge, no systematic review specifically focusing on the effectiveness and safety of traditional Chinese medicine-based pediatric Tui na for FI in premature infants has been published yet.

OBJECTIVE

This study aims to develop a protocol for a systematic review and meta-analysis for evaluating the safety and efficacy of pediatric Tui na for premature infants with FI.

METHODS

We will perform a comprehensive search in the following databases: Springer, Cochrane Library, Embase, MEDLINE, Clarivate Analytics, Physiotherapy Evidence Database (PEDro), CINAHL, PubMed, Scopus, World Health Organization (WHO) International Clinical Trials Registry Platform, and Chinese biomedical databases (Wanfang database, the China National Knowledge Infrastructure, Chinese Scientific Journals Database, and Chinese Biomedical Literature Databases), limited to studies published in Chinese and English languages between January 2000 and January 2023. The search strategy will use MeSH (Medical Subject Headings) terms and database-specific keywords. A total of 2 independent reviewers will initially screen the studies based on titles and abstracts, followed by a full-text evaluation of the eligible studies. Studies will include any nonrandomized controlled trials, nonrandomized clinical studies, randomized controlled trials, and quasi-experimental studies wherein the treatment group involves premature infants with FI given pediatric Tui na. Primary outcomes will be necrotizing enterocolitis, gastric residual volume, emesis, and stool blood. Secondary outcomes will be abdominal distension weight gain, time to achieve full enteral feeding, any adverse effects associated with pediatric Tui na, and length of hospital stay. The Cochrane Collaboration Risk of Bias Tool will be used to assess the risk of bias and methodological quality. Funnel plots will be used for evaluating publication bias. Meta-analysis will be conducted using the Review Manager software (version 5.4; Cochrane Collaboration). Subgroup analyses will be considered according to treatment received, country or setting, sex, and birth weight of premature infants (if heterogeneity is high, I≥50%).

RESULTS

This is a systematic review and meta-analysis protocol, so the results are not yet available. The protocol has been registered with PROSPERO (CRD42023390021). We are currently in the study selection phase. Results are expected to be completed by the end of 2023.

CONCLUSIONS

Following this protocol, a comprehensive and rigorous literature synthesis will be developed to assess the impact of pediatric Tui na treatment on premature infants with FI, enabling the determination of its efficacy and safety.

TRIAL REGISTRATION

PROSPERO CRD42023390021; https://tinyurl.com/bdf4kn23.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46375.

摘要

背景

喂养不耐受(FI)在早产儿中普遍存在,常因胃肠道发育不成熟所致。考虑到长期用药的潜在副作用,目前的做法逐渐将非药物治疗(如按摩或“推拿”)列为优先选择。小儿推拿是一种基于中医的专业按摩疗法,已被广泛研究用于治疗早产儿的FI。然而,据我们所知,尚未发表专门针对基于中医的小儿推拿治疗早产儿FI的有效性和安全性的系统评价。

目的

本研究旨在制定一项系统评价和荟萃分析方案,以评估小儿推拿治疗早产儿FI的安全性和疗效。

方法

我们将在以下数据库中进行全面检索:施普林格、考科蓝图书馆、Embase、MEDLINE、科睿唯安分析、物理治疗证据数据库(PEDro)、护理学与健康领域数据库(CINAHL)、PubMed、Scopus、世界卫生组织(WHO)国际临床试验注册平台以及中国生物医学数据库(万方数据库、中国知网、维普数据库和中国生物医学文献数据库),检索范围限于2000年1月至2023年1月发表的中英文研究。检索策略将使用医学主题词(MeSH)术语和特定数据库的关键词。共有2名独立评审员将首先根据标题和摘要筛选研究,然后对符合条件的研究进行全文评估。研究将包括任何非随机对照试验、非随机临床研究、随机对照试验和准实验研究,其中治疗组涉及接受小儿推拿的FI早产儿。主要结局将是坏死性小肠结肠炎、胃残余量、呕吐和便血。次要结局将是腹胀、体重增加、达到完全肠内喂养的时间、与小儿推拿相关的任何不良反应以及住院时间。将使用考科蓝协作偏倚风险工具评估偏倚风险和方法学质量。漏斗图将用于评估发表偏倚。将使用Review Manager软件(版本5.4;考科蓝协作)进行荟萃分析。将根据接受的治疗、国家或地区、性别以及早产儿的出生体重(如果异质性较高,I≥50%)进行亚组分析。

结果

这是一项系统评价和荟萃分析方案,因此结果尚未可得。该方案已在国际前瞻性注册系统(PROSPERO)注册(CRD42023390021)。我们目前处于研究选择阶段。预计结果将于2023年底完成。

结论

按照本方案,将开展全面、严谨的文献综合分析,以评估小儿推拿治疗对FI早产儿的影响,从而确定其疗效和安全性。

试验注册

国际前瞻性注册系统(PROSPERO)CRD42023390021;https://tinyurl.com/bdf4kn23。

国际注册报告识别号(IRRID):PRR1-10.2196/46375。

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