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世界过敏组织全身过敏反应分级系统:是否需要修订?

World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed?

作者信息

Cox Linda S, Sanchez-Borges Mario, Lockey Richard F

机构信息

Department of Medicine, University of Miami Miller School of Medicine at Holy Cross Hospital, Ft Lauderdale, Fla.

Allergy and Clinical Immunology Department, Centro Médico Docente La Trinidad, Caracas, Venezuela.

出版信息

J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):58-62.e5. doi: 10.1016/j.jaip.2016.11.009.

Abstract

There is no universally accepted grading system to classify the severity of systemic allergic reactions (SARs), including anaphylaxis. Although a consensus definition for anaphylaxis was established in 2005, the signs and symptoms required to define a reaction as anaphylaxis are inconsistently applied in research and clinical practice. As a result, it is difficult to compare and evaluate safety outcomes in surveys, clinical practice and trials, and pharmacovigilance data. In 2010, the World Allergy Organization (WAO) proposed a uniform grading system to classify allergen immunotherapy SARs. The basis of the grading system is the organ system(s) involved and reaction severity. The final grade is determined by the physician/health care professional after the event is over. Although the 2010 WAO grading system was developed to classify allergen immunotherapy SARs, with appropriate modifications, it can be used to classify SARs from any cause. The purpose of this Rostrum is to present a proposed modification of the 2010 WAO SAR grading system that will make it applicable to all SARs due to any cause. The modified grading system allows for classification of less severe SARs, which may be underreported or overreported in clinical trials and surveillance studies, depending on the criteria specified for adverse event reporting. The universal use of the proposed modified SAR grading system will allow for better safety comparisons across different venues and treatment protocols.

摘要

目前尚无普遍接受的分级系统来对包括过敏反应在内的全身性过敏反应(SARs)的严重程度进行分类。尽管2005年已确立了过敏反应的共识定义,但在研究和临床实践中,将某种反应定义为过敏反应所需的体征和症状的应用并不一致。因此,在调查、临床实践和试验以及药物警戒数据中,很难比较和评估安全性结果。2010年,世界过敏组织(WAO)提出了一种统一的分级系统,用于对变应原免疫治疗的SARs进行分类。该分级系统的基础是受累的器官系统和反应的严重程度。最终分级由医生/医疗保健专业人员在事件结束后确定。尽管2010年WAO分级系统是为对变应原免疫治疗的SARs进行分类而制定的,但经过适当修改后,它可用于对任何原因引起的SARs进行分类。本述评的目的是提出对2010年WAO SAR分级系统的一项拟议修改,使其适用于任何原因引起的所有SARs。修改后的分级系统能够对不太严重的SARs进行分类,在临床试验和监测研究中,根据不良事件报告规定的标准,这些不太严重的SARs可能报告不足或报告过度。拟议的修改后的SAR分级系统的普遍使用将有助于在不同场所和治疗方案之间更好地比较安全性。

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