Hernandez-Mezquita Miguel A, Santos-Ventura Idania De Los, Hidalgo-Sierra Vanesa, Pérez-Trullen Alfonso, Garcia Ruth García, Clavero-Sánchez Tamara, Barrueco-Otero Enrique
Pneumology Department, Salamanca University Hospital, 37007 Salamanca, Spain.
Department of Medicine, University of Salamanca (USAL), 37007 Salamanca, Spain.
J Clin Med. 2025 Jan 17;14(2):576. doi: 10.3390/jcm14020576.
: Chronic obstructive pulmonary disease (COPD) is a frequent but underdiagnosed disease, primarily due to the lack of access to forced spirometry (FS) in primary care. Portable, easy-to-use expiratory flow meters like Piko-6 and COPD-6 that measure FEV, FEV, and FEV/FEV ratio provide an alternative. Given that Piko-6 and COPD-6 devices measure FEV but not FVC, the aim of the study is to determine the optimal cutoff value for the FEV/FEV ratio of each device to avoid false negatives when these devices are used for COPD screening in primary care (PC). : A total of 664 patients of 35 years of age or older with a cumulative tobacco consumption of 10 or more packs/year were recruited at two university hospitals. FS (gold standard) was performed and FEV, FVC, and FEV/FVC measurements were compared with FEV, FEV, and FEV/FEV measurements acquired using Piko-6 and COPD-6 devices. The devices were compared using statistical methods including Pearson correlation coefficients, the Youden index (YI), kappa coefficient, Bland-Altman plots, and ROC curves analysis. : Correlations between FEV/FEV using Piko-6 and COPD-6 and FEV/FVC with FS were 0.79 and 0.73, respectively. Piko-6 achieved the best YI in FEV/FEV (0.73), whereas for COPD-6, it was 0.80. Concordance between Piko-6 and FS was 83.9% (kappa 0.67 ± 0.028) and for COPD-6, it was 68.7% (kappa 0.42 ± 0.02). : This is the first study that compares two hand-held expiratory flow meters with FS. Piko-6 and COPD-6 devices are effective tools for COPD detection, as their measurements provide a good correlation with FS. In order to avoid false negative results, the FEV/FEV cutoff point needs to be increased to 0.73 and 0.80 with Piko-6 and COPD-6, respectively.
慢性阻塞性肺疾病（COPD）是一种常见但诊断不足的疾病，主要原因是基层医疗中无法进行肺功能仪测定（FS）。像Piko - 6和COPD - 6这样的便携式、易于使用的呼气流量计可以测量第一秒用力呼气容积（FEV₁）、用力肺活量（FVC）和FEV₁/FVC比值，提供了一种替代方法。鉴于Piko - 6和COPD - 6设备测量FEV₁但不测量FVC，本研究的目的是确定每种设备的FEV₁/FEV₁比值的最佳截断值，以避免在基层医疗（PC）中使用这些设备进行COPD筛查时出现假阴性。
在两家大学医院共招募了664名年龄在35岁及以上、累积吸烟量为每年10包或更多的患者。进行了肺功能仪测定（金标准），并将FEV₁、FVC和FEV₁/FVC测量值与使用Piko - 6和COPD - 6设备获得的FEV₁、FEV₁和FEV₁/FEV₁测量值进行比较。使用包括Pearson相关系数、约登指数（YI）、kappa系数、Bland - Altman图和ROC曲线分析在内的统计方法对这些设备进行比较。
使用Piko - 6和COPD - 6时FEV₁/FEV₁与使用肺功能仪测定时的FEV₁/FVC之间的相关性分别为0.79和0.73。Piko - 6在FEV₁/FEV₁方面获得了最佳约登指数（0.73），而COPD - 6的约登指数为0.8。Piko - 6与肺功能仪测定的一致性为83.9%（kappa 0.67±0.028），COPD - 6与肺功能仪测定的一致性为68.7%（kappa 0.42±0.02）。
这是第一项将两种手持式呼气流量计与肺功能仪测定进行比较的研究。Piko - 6和COPD - 6设备是检测COPD的有效工具，因为它们的测量值与肺功能仪测定有良好的相关性。为了避免假阴性结果，使用Piko - 6和COPD - 6时，FEV₁/FEV₁的截断点分别需要提高到0.73和0.80。
