定义重症哮喘超级应答者：基于德尔菲法的发现
2021/07/28
摘要
背景：临床医生越来越认识到经生物制剂和其他附加治疗使重症哮喘显著改善。目前还无超级应答者（SR）统一的定义。
目的：采用改进的德尔菲法对重症哮喘专家进行调查，以期建立一个基于国际共识的重症哮喘“超级反应者”定义。
方法：德尔菲小组由来自24个国家的81名专家（94%是呼吸科专家或过敏专家）组成，包括3轮在线投票。就个别项目达成共识，无论是接受还是拒绝，都需要专家组成员至少70%的同意。
结果：专家一致认为SR的定义应基于12个月内评估的3个或更多领域的改善。主要的SR标准包括消除急性发作，哮喘控制有很大改善(≥2倍的最小临床重要差异）和停止维持口服类固醇（或无肾上腺功能不全）。轻微SR标准包括75%的急性发作减轻，哮喘控制良好，FEV1改善500mL或更大。SR定义至少需要两个主要标准上的改进。在未来SR的定义应该扩展到包括生活质量的改善，尽管目前的评估工具很难在临床环境中实施，还需要进一步的研究。
结论：基于国际共识的重症哮喘超级应答者的定义是更好地了解超级应答者患病率、预测因素和相关机制的重要前提。需要进一步的研究来了解病人的观点，更准确地衡量超级应答者的生活质量。
Defining a severe asthma super-responder: findings from a Delphi process
John W Upham, Chantal Le Lievre, David J Jackson, Matthew Masoli, Michael E Wechsler, David B Price, Delphi Panel
Abstract
Background: Clinicians are increasingly recognising severe asthma patients in whom biologicals and other add-on therapies lead to dramatic improvement. Currently, there is no agreed upon super-responder (SR) definition.
Objective: To survey severe asthma experts using a modified Delphi process in order to develop an international consensus-based definition of a severe asthma 'super-responder'.
Methods: The Delphi panel comprised 81 participants (94% specialist pulmonologists or allergists) from 24 countries and consisted of 3 iterative online voting rounds. Consensus on individual items, whether acceptance or rejection, required at least 70% agreement by panel members.
Results: Consensus was achieved that the SR definition should be based on improvement across 3 or more domains assessed over 12 months. Major SR criteria included exacerbation elimination, a large improvement in asthma control (≥ 2x the minimal clinically important difference) and cessation of maintenance of oral steroids (or weaning to adrenal insufficiency). Minor SR criteria comprised a 75% exacerbation reduction, having well controlled asthma and a 500mL or greater improvement in FEV1. The SR definition requires improvement in at least 2 major criteria. In the future, the SR definition should be expanded to incorporate quality of life measures, though current tools can be difficult to implement in a clinical setting and further research is needed.
Conclusions: This international consensus-based definition of severe asthma super responders is an important prerequisite for better understanding super-responder prevalence, predictive factors and the mechanisms involved. Further research is needed to understand the patient perspective and measure quality of life more precisely in super-responders.
背景：临床医生越来越认识到经生物制剂和其他附加治疗使重症哮喘显著改善。目前还无超级应答者（SR）统一的定义。
目的：采用改进的德尔菲法对重症哮喘专家进行调查，以期建立一个基于国际共识的重症哮喘“超级反应者”定义。
方法：德尔菲小组由来自24个国家的81名专家（94%是呼吸科专家或过敏专家）组成，包括3轮在线投票。就个别项目达成共识，无论是接受还是拒绝，都需要专家组成员至少70%的同意。
结果：专家一致认为SR的定义应基于12个月内评估的3个或更多领域的改善。主要的SR标准包括消除急性发作，哮喘控制有很大改善(≥2倍的最小临床重要差异）和停止维持口服类固醇（或无肾上腺功能不全）。轻微SR标准包括75%的急性发作减轻，哮喘控制良好，FEV1改善500mL或更大。SR定义至少需要两个主要标准上的改进。在未来SR的定义应该扩展到包括生活质量的改善，尽管目前的评估工具很难在临床环境中实施，还需要进一步的研究。
结论：基于国际共识的重症哮喘超级应答者的定义是更好地了解超级应答者患病率、预测因素和相关机制的重要前提。需要进一步的研究来了解病人的观点，更准确地衡量超级应答者的生活质量。
(中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校)
(J Allergy Clin Immunol Pract. 2021 Jul 13;S2213-2198(21)00772-8. doi: 10.1016/j.jaip.2021.06.041.)
(J Allergy Clin Immunol Pract. 2021 Jul 13;S2213-2198(21)00772-8. doi: 10.1016/j.jaip.2021.06.041.)
Defining a severe asthma super-responder: findings from a Delphi process
John W Upham, Chantal Le Lievre, David J Jackson, Matthew Masoli, Michael E Wechsler, David B Price, Delphi Panel
Abstract
Background: Clinicians are increasingly recognising severe asthma patients in whom biologicals and other add-on therapies lead to dramatic improvement. Currently, there is no agreed upon super-responder (SR) definition.
Objective: To survey severe asthma experts using a modified Delphi process in order to develop an international consensus-based definition of a severe asthma 'super-responder'.
Methods: The Delphi panel comprised 81 participants (94% specialist pulmonologists or allergists) from 24 countries and consisted of 3 iterative online voting rounds. Consensus on individual items, whether acceptance or rejection, required at least 70% agreement by panel members.
Results: Consensus was achieved that the SR definition should be based on improvement across 3 or more domains assessed over 12 months. Major SR criteria included exacerbation elimination, a large improvement in asthma control (≥ 2x the minimal clinically important difference) and cessation of maintenance of oral steroids (or weaning to adrenal insufficiency). Minor SR criteria comprised a 75% exacerbation reduction, having well controlled asthma and a 500mL or greater improvement in FEV1. The SR definition requires improvement in at least 2 major criteria. In the future, the SR definition should be expanded to incorporate quality of life measures, though current tools can be difficult to implement in a clinical setting and further research is needed.
Conclusions: This international consensus-based definition of severe asthma super responders is an important prerequisite for better understanding super-responder prevalence, predictive factors and the mechanisms involved. Further research is needed to understand the patient perspective and measure quality of life more precisely in super-responders.
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我是如何做的：重症哮喘的诊断检查
