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食物过敏免疫治疗后的终点指标和结局:对患者而言什么是有意义的?

Endpoints and Outcomes After Immunotherapy for Food Allergy: What Is Meaningful for Patients?

作者信息

Lloyd Melanie, Patel Nandinee, Munblit Daniel, Tang Mimi L K

机构信息

Allergy Immunology, Murdoch Children's Research Institute, Parkville, VIC, Australia; Centre for Medicine Use and Safety, Monash University, Parkville, VIC, Australia.

National Heart and Lung Institute, Imperial College London, London, United Kingdom.

出版信息

J Allergy Clin Immunol Pract. 2023 Apr;11(4):998-1007. doi: 10.1016/j.jaip.2023.01.033. Epub 2023 Feb 1.

DOI:10.1016/j.jaip.2023.01.033
PMID:36736959
Abstract

Multiple novel interventions for food allergy are currently at various stages of development with the goal of reducing or eliminating allergic reactions. However, the relative success of these therapeutics in achieving meaningful, long-term improvements to patients' lives is difficult to determine as there is currently very limited understanding of the degree of alignment between clinical trial efficacy endpoints and patient-centered outcomes. Furthermore, outcome measures used in clinical trials of food allergy immunotherapies vary widely, are often misinterpreted, and not necessarily consistent with what patients expect to achieve through treatment. This review aims to assist clinicians in critically interpreting outcomes reported in clinical trials and accurately communicating risks and outcomes to patients when practicing shared decision-making.

摘要

目前,多种针对食物过敏的新型干预措施正处于不同的开发阶段,目标是减少或消除过敏反应。然而,由于目前对临床试验疗效终点与以患者为中心的结果之间的一致性程度了解非常有限,很难确定这些疗法在实现对患者生活有意义的长期改善方面的相对成功率。此外,食物过敏免疫疗法临床试验中使用的结果测量方法差异很大,常常被误解,而且不一定与患者期望通过治疗实现的目标一致。本综述旨在帮助临床医生批判性地解释临床试验中报告的结果,并在进行共同决策时准确地向患者传达风险和结果。

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