Szefler Stanley J, Goldstein Stanley, Vogelberg Christian, Bensch George W, Given John, Jugovic Branko, Engel Michael, Moroni-Zentgraf Petra M, Sigmund Ralf, Hamelmann Eckard H
Department of Pediatrics, The Breathing Institute, Children's Hospital of Colorado, University of Colorado School of Medicine, Aurora, CO, USA.
Allergy and Asthma Care of Long Island, Rockville Centre, NY, USA.
Pulm Ther. 2020 Dec;6(2):151-158. doi: 10.1007/s41030-020-00117-6. Epub 2020 May 12.
In pediatric patients with asthma, measurements of forced expiratory volume in 1 s (FEV) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25-75% of the vital capacity (FEF) is a potentially more sensitive parameter for assessing peripheral airway function. This post hoc analysis compared FEF with FEV as an endpoint to assess bronchodilator responsiveness in children with asthma.
Change from baseline in trough FEF and trough FEV following treatment with either tiotropium (5 µg or 2.5 µg) or placebo Respimat was analyzed in four phase III trials in children (aged 6-11 years) and adolescents (aged 12-17 years) with symptomatic moderate (VivaTinA-asthma and PensieTinA-asthma) and mild (CanoTinA-asthma and RubaTinA-asthma) asthma. Data from all treatment arms were pooled and correlations between FEF and FEV were calculated and analyzed.
A total of 1590 patients were included in the analysis. Tiotropium Respimat consistently improved FEF and FEV versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant. Improvements in FEF response with tiotropium versus placebo were largely more pronounced than improvements in FEV. Statistical assessment of the correlation of FEV and FEF showed moderate-to-high correlations (Pearson's correlation coefficients 0.73-0.80).
In pediatric patients, FEF may be a more sensitive measure to detect treatment response, certainly to tiotropium, than FEV and should be evaluated as an additional lung function measurement.
在患有哮喘的儿科患者中，1秒用力呼气量（FEV）的测量结果可能正常，也可能与症状严重程度无关。肺活量25%-75%时的用力呼气流量（FEF）是评估外周气道功能的一个潜在更敏感的参数。这项事后分析比较了FEF和FEV作为评估哮喘儿童支气管扩张剂反应性的终点指标。
在四项针对6至11岁儿童和12至17岁青少年的III期试验中，分析了使用噻托溴铵（5μg或2.5μg）或安慰剂软雾吸入剂治疗后，FEF谷值和FEV谷值相对于基线的变化。这些儿童患有症状性中度（VivaTinA-哮喘和PensieTinA-哮喘）和轻度（CanoTinA-哮喘和RubaTinA-哮喘）哮喘。汇总所有治疗组的数据，计算并分析FEF和FEV之间的相关性。
共有1590名患者纳入分析。与安慰剂相比，噻托溴铵软雾吸入剂持续改善了FEF和FEV，尽管在重度哮喘青少年中，观察到的改善无统计学意义。与安慰剂相比，噻托溴铵在FEF反应方面的改善大多比FEV的改善更明显。对FEV和FEF相关性的统计评估显示中度至高相关性（Pearson相关系数为0.73-0.80）。
在儿科患者中，FEF可能是比FEV更敏感的检测治疗反应的指标，尤其是对噻托溴铵，应将其作为一项额外的肺功能测量指标进行评估。
