Abstract:
Food allergy affects a large population throughout the world. Recently, oral immunotherapy (OIT) has been reported as an effective treatment for severe food allergy. Although OIT was successful in numerous trials in desensitisation, adverse events including anaphylaxis during OIT frequently occur. Additionally, some patients fail to be desensitised after OIT and the response to treatment is often not sustained. As a further adjunctive therapy to facilitate OIT, the role of biological agents has been identified. For example, efficacy and safety of omalizumab as an adjuvant therapy of OIT has become apparent through some RCTs and observational studies. Interest towards this topic is growing worldwide, and ongoing trials will provide additional data on the biologics in food allergy.We aim to systematically analyse the efficacy and safety of OIT combined with biological agents for food allergy.
This paper provides a protocol for a systematic review of the relevant published analytical studies using an aggregate approach following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. Two authors will perform a comprehensive search for studies on MEDLINE/PubMed, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) databases. Subsequently, two independent authors will perform abstract screening, full-text screening and data extraction. A meta-analysis will be conducted as appropriate.
The protocol of this systematic review will be provided in a peer-reviewed journal. As the researchers will not identify the individual patients included in the studies, they do not need to acquire ethics approval.
CRD42022373015.
摘要:
背景:食物过敏影响全世界的大量人口。最近,据报道,口服免疫疗法(OIT)是治疗严重食物过敏的有效方法.尽管OIT在许多脱敏试验中取得了成功,OIT期间经常发生包括过敏反应在内的不良事件。此外,一些患者在OIT后未能脱敏,对治疗的反应往往不能持续.作为促进OIT的进一步辅助疗法,生物制剂的作用已经确定。例如,通过一些RCT和观察性研究,奥马珠单抗作为OIT辅助治疗的有效性和安全性已变得明显.全世界对这个话题的兴趣越来越大,正在进行的试验将提供有关食物过敏中生物制剂的其他数据。我们旨在系统分析OIT联合生物制剂治疗食物过敏的疗效和安全性。
方法:本文根据系统评价和荟萃分析方案的首选报告项目指南,使用汇总方法对相关已发表的分析研究进行系统评价。两位作者将对MEDLINE/PubMed的研究进行全面搜索,EMBASE和Cochrane中央对照试验登记册(CENTRAL)数据库。随后,两名独立作者将进行抽象筛选,全文筛选和数据提取。将酌情进行荟萃分析。
背景:本系统综述的方案将在同行评审的期刊中提供。由于研究人员不会确定研究中包含的个体患者,他们不需要获得道德批准。
■CRD42022373015。