变应原免疫疗法：生物标志物与临床结局指标
Allergen Immunotherapy: Biomarkers and Clinical Outcome Measures.
作者信息
Pitsios Constantinos
机构信息
Allergy Outpatient Clinic, Medical School, University of Cyprus, Nicosia, Cyprus.
出版信息
J Asthma Allergy. 2021 Feb 18;14:141-148. doi: 10.2147/JAA.S267522. eCollection 2021.
Abstract
Clinical trials for allergen immunotherapy products' development and approval are conducted, aiming to monitor safety and efficacy of them. Symptom scores and the use of rescue medication are the primary clinical endpoints used in the conducted clinical trials, while Quality of Life scores and symptom-free days are measurements also used as secondary endpoints. Although the use of in vitro biomarkers might have been more practical and objective, there are yet no broadly used reliable ones accurately reflecting the clinical effects of allergen immunotherapy. On the contrary, in vivo biomarkers, such as the nasal allergy provocation test, are reliable and successfully used. The aim of this review is to describe how to adapt and use biomarkers and clinical outcomes in the everyday practice of Allergists who perform allergen immunotherapy.
摘要
开展了变应原免疫疗法产品研发和审批的临床试验，旨在监测其安全性和有效性。症状评分和急救药物的使用是所开展临床试验中使用的主要临床终点指标，而生活质量评分和无症状天数也是用作次要终点指标的测量方法。尽管使用体外生物标志物可能会更实用和客观，但目前尚无广泛使用的能准确反映变应原免疫疗法临床效果的可靠生物标志物。相反，体内生物标志物，如鼻过敏激发试验，是可靠且成功应用的。本综述的目的是描述如何在进行变应原免疫疗法的过敏症专科医生的日常实践中采用和使用生物标志物及临床结果。
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