, Philadelphia, USA.
Vision Clinical Research, 1501 San Elijo Road, Suite 104, #213, San Marcos, CA, 92078, USA.
BMC Pulm Med. 2020 May 14;20(1):139. doi: 10.1186/s12890-020-1166-2.
Asthma is a complex syndrome with multiple domains including symptoms, lung function, asthma control, and airway inflammation. A study of Fenom PRO™, a novel monitor for exhaled nitric oxide (FeNO), provided an opportunity to look at concordance/discordance (C/D) for changes in multiple asthma domains over a 2-week period after corticosteroid therapy.
Non-steroid-treated adults and children with uncontrolled asthma had asthma domain measures, (FeNO), forced expired volume in 1 s (FEV), the 6-item Asthma Control Questionnaire scores (ACQ6), and daily asthma symptoms, assessed before and after a 2-week course of corticosteroids. Asthma symptoms were assessed using a custom novel twice-daily symptom scale (ASX). C/D bidirectional changes in all domains were calculated around both the zero point, and around the minimal important difference (MID) in relevant subjects.
There was a highly significant fall in mean FeNO of 51.7% over 2 weeks (p < 0.0001) accompanied by significant improvements in mean FEV, ACQ6 and ASX scores. However, C/D between individual domains varied considerably between subjects. The C/D between parameters for any change around zero for the combined adults and pediatric population was best for FeNO and ACQ6, 79.3/20.7% while FEV was more discordant than other parameters in general. When considering changes around the minimal important difference (MID) in a subset, the level of concordance increased in general, with FeNO and ACQ6 demonstrating a C/D of 93.5/6.6%.
This data demonstrates that the concordance between changes in the asthma domains is often substantially less than 100%. Reasons for this may include different time courses for change of the separate domains, the degree of abnormality for each domain at baseline, as well as intrinsic limitations of each parameter.
哮喘是一种具有多种领域的复杂综合征，包括症状、肺功能、哮喘控制和气道炎症。一项关于 Fenom PRO™（一种新型呼出气一氧化氮（FeNO）监测仪）的研究提供了一个机会，可以观察在皮质类固醇治疗后 2 周内，多个哮喘领域的变化是否一致/不一致（C/D）。
未经类固醇治疗的未控制哮喘的成人和儿童，在接受皮质类固醇治疗前和治疗后 2 周内，对哮喘领域的各项指标（FeNO）、1 秒用力呼气量（FEV）、6 项哮喘控制问卷评分（ACQ6）和每日哮喘症状进行评估。哮喘症状使用一种新的定制的每日两次症状量表（ASX）进行评估。在相关受试者中，围绕零值和最小重要差异（MID），计算所有领域的 C/D 双向变化。
在 2 周内，FeNO 的平均下降了 51.7%，具有统计学意义（p < 0.0001），同时 FEV、ACQ6 和 ASX 评分也有显著改善。然而，个体之间各领域的 C/D 变化差异很大。在成人和儿科患者的组合中，围绕零值的任何变化参数的 C/D 最佳的是 FeNO 和 ACQ6，分别为 79.3%/20.7%，而 FEV 通常比其他参数更不一致。当考虑到亚组中最小重要差异（MID）周围的变化时，一致性水平通常会提高，FeNO 和 ACQ6 表现出的 C/D 为 93.5%/6.6%。
这些数据表明，哮喘领域的变化之间的一致性通常远低于 100%。造成这种情况的原因可能包括各个领域的变化时间不同、每个领域的基线异常程度不同，以及每个参数的固有局限性。
