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意大利重症哮喘网络关于重症哮喘临床缓解的定义:德尔菲共识

Severe Asthma Network Italy Definition of Clinical Remission in Severe Asthma: A Delphi Consensus.

作者信息

Canonica Giorgio Walter, Blasi Francesco, Carpagnano Giovanna Elisiana, Guida Giuseppe, Heffler Enrico, Paggiaro Pierluigi, Allegrini Chiara, Antonelli Andrea, Aruanno Arianna, Bacci Elena, Bagnasco Diego, Beghè Bianca, Bonavia Marco, Bonini Matteo, Brussino Luisa, Caiaffa Maria Filomena, Calabrese Cecilia, Camiciottoli Gianna, Caminati Marco, Caruso Cristiano, Cavallini Mirta, Chieco Bianchi Fulvia, Conte Maria Elisabetta, Corsico Angelo Guido, Cosmi Lorenzo, Costantino Mariateresa, Costanzo Giulia, Crivellaro Mariaangiola, D'Alò Simona, D'Amato Mariella, Detoraki Aikaterini, Di Proietto Maria Carmela, Facciolongo Nicola Cosimo, Ferri Sebastian, Fierro Vincenzo, Foschino Maria Pia, Latorre Manuela, Lombardi Carlo, Macchia Luigi, Milanese Manlio, Montagni Marcello, Parazzini Elena Maria, Parente Roberta, Passalacqua Giovanni, Patella Vincenzo, Pelaia Girolamo, Pini Laura, Puggioni Francesca, Ricciardi Luisa, Ridolo Erminia, Rolo Joyce, Scichilone Nicola, Scioscia Giulia, Senna Gianenrico, Solidoro Paolo, Varricchi Gilda, Vianello Andrea, Yacoub Mona Rita, Yang Baoran

机构信息

Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Respiratory Unit and Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.

出版信息

J Allergy Clin Immunol Pract. 2023 Dec;11(12):3629-3637. doi: 10.1016/j.jaip.2023.07.041. Epub 2023 Aug 7.

Abstract

Severe asthma affects about 10% of the population with asthma and is characterized by low lung function and a high count of blood leukocytes, mainly eosinophils. Various definitions are used in clinical practice and in the literature to identify asthma remission: clinical remission, inflammatory remission, and complete remission. This work highlights a consensus for asthma remission using a Delphi method. In the context of the Severe Asthma Network Italy, which accounts for 57 severe asthma centers and more than 2,200 patients, a board of six experts drafted a list of candidate statements in a questionnaire, which has been revised to minimize redundancies and ensure clear and consistent wording for the first round (R1) of the analysis. Thirty-two statements were included in the R1 questionnaire and then submitted to a panel of 80 experts, which used a 5-point Likert scale to measure agreement regarding each statement. Then, an interim analysis of R1 data was performed, and items were discussed and considered to produce a consistent questionnaire for round 2 (R2) of the analysis. Then, the board set the R2 questionnaire, which included only important topics. Panelists were asked to vote on the statements in the R2 questionnaire afterward. During R2, the criteria of complete clinical remission (the absence of the need for oral corticosteroids, symptoms, exacerbations or attacks, and pulmonary function stability) and those of partial clinical remission (the absence of the need for oral corticosteroids, and two of three criteria: the absence of symptoms, exacerbations or attacks, and pulmonary stability) were confirmed. This Severe Asthma Network Italy Delphi analysis defined a valuable and independent tool that is easy to use, to test the efficacy of different treatments in patients with severe asthma enrolled into the SANI registry.

摘要

重度哮喘影响约10%的哮喘患者,其特征为肺功能低下以及血液白细胞(主要是嗜酸性粒细胞)计数偏高。临床实践和文献中使用了各种定义来确定哮喘缓解:临床缓解、炎症缓解和完全缓解。这项工作通过德尔菲法突出了哮喘缓解的共识。在意大利重度哮喘网络的背景下,该网络包括57个重度哮喘中心和2200多名患者,一个由六名专家组成的委员会在一份问卷中起草了候选陈述清单,该清单已进行修订,以尽量减少冗余,并确保在第一轮(R1)分析中措辞清晰一致。R1问卷中包含32条陈述,然后提交给一个由80名专家组成的小组,该小组使用5点李克特量表来衡量对每条陈述的认同程度。然后,对R1数据进行了中期分析,并对项目进行了讨论和审议,以生成第二轮(R2)分析的一致问卷。然后,委员会确定了R2问卷,其中只包括重要主题。之后,要求小组成员对R2问卷中的陈述进行投票。在R2期间,确认了完全临床缓解(无需口服糖皮质激素、无症状、无加重或发作以及肺功能稳定)和部分临床缓解(无需口服糖皮质激素,以及以下三个标准中的两个:无症状、无加重或发作以及肺功能稳定)的标准。意大利重度哮喘网络的这项德尔菲分析定义了一种有价值且独立的工具,该工具易于使用,可用于测试纳入SANI登记册的重度哮喘患者中不同治疗方法的疗效。

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