背景:混合和非IgE介导的食物过敏是免疫介导的不良食物反应的一个子集,可对受影响患者及其家人的生活质量造成重大负担。研究这些疾病的临床试验依赖于与患者和临床医生相关的一致和有效的结果测量。但是这种严格的结果报告发生的程度研究很少。
目标:作为食物过敏核心成果措施(COMFA)项目的一部分,我们确定了混合或非IgE介导的食物过敏治疗的随机临床试验(RCT)报道的结局.
方法:在这篇系统综述中,我们搜查了Ovid,MEDLINE和Embase数据库,用于儿童或成人研究食物蛋白诱导的小肠结肠炎综合征的治疗方法,食物蛋白诱导的过敏性直肠结肠炎,食物蛋白引起的肠病和嗜酸性粒细胞性胃肠道疾病,包括嗜酸性粒细胞性食管炎[EoE],嗜酸性粒细胞性胃炎和嗜酸性粒细胞性结肠炎发表至2022年10月14日。
结果:确定了26项符合条件的研究,23人专注于EoE(88%)。大多数干预措施是皮质类固醇或单克隆抗体。所有EoE研究都评估了患者报告的吞咽困难,通常使用未经验证的问卷。23项EoE研究中有22项使用组织嗜酸性粒细胞峰值计数作为主要结果,通常使用未经验证的评估方法,和其他免疫标记只是探索性的。13项(57%)EoE研究报告了内窥镜结果,其中6项使用最近推荐的经过验证的评分工具作为EoE试验的核心结果。资金来源与RCT报告机制与患者报告结果的可能性没有明显关联。只有3个(12%)RCT与EoE以外的食物过敏有关,他们报告了粪便免疫标志物和患者报告的结局。
结论:在EoE和非IgE介导的食物过敏的临床试验中测量的结果是异质的,并且在很大程度上是未经验证的。EoE的核心结果已经开发出来,需要在未来的试验中使用。对于其他形式的混合或非IgE介导的食物过敏,需要核心结果的发展来支持有效治疗的发展。
背景:OSF公共注册表DOI:10.17605/OSF。IO/AZX8S。
Mixed and non-IgE-mediated food allergy is a subset of immune-mediated adverse food reactions that can impose a major burden on the quality of life of affected patients and their families. Clinical trials to study these diseases are reliant upon consistent and valid outcome measures that are relevant to both patients and clinicians, but the degree to which such stringent outcome reporting takes place is poorly studied.
As part of the Core Outcome Measures for Food Allergy (COMFA) project, we identified outcomes reported in randomized clinical trials (RCT) of treatments for mixed or non-IgE-mediated food allergy.
In this systematic review, we searched the Ovid, MEDLINE and Embase databases for RCTs in children or adults investigating treatments for food protein-induced enterocolitis syndrome, food protein-induced allergic proctocolitis, food protein-induced enteropathy and eosinophilic gastrointestinal disorders including eosinophilic esophagitis [EoE], eosinophilic gastritis and eosinophilic colitis published until 14 October 2022.
Twenty-six eligible studies were identified, with 23 focused on EoE (88%). Most interventions were corticosteroids or monoclonal antibodies. All EoE studies assessed patient-reported dysphagia, usually using a non-validated questionnaire. Twenty-two of 23 EoE studies used peak tissue eosinophil count as the primary outcome, usually using a non-validated assessment method, and other immunological markers were only exploratory. Thirteen (57%) EoE studies reported endoscopic outcomes of which six used a validated scoring tool recently recommended as a core outcome for EoE trials. Funding source was not obviously associated with likelihood of an RCT reporting mechanistic versus patient-reported outcomes. Only 3 (12%) RCTs concerned forms of food allergy other than EoE, and they reported on fecal immunological markers and patient-reported outcomes.
Outcomes measured in clinical trials of EoE and non-IgE-mediated food allergy are heterogeneous and largely non-validated. Core outcomes for EoE have been developed and need to be used in future trials. For other forms of mixed or non-IgE-mediated food allergies, core outcome development is needed to support the development of effective treatments.
OSF public registry DOI:10.17605/OSF.IO/AZX8S.