国产新型压差式肺量计优呼吸PF680的测量值评价  

Performance Evaluation of Spirometer PF680,a New Domestically-made Spirometer Based on Differential Pressure Sensing

作　　者：钟丽萍[1] 吴仲平[1] 黄锐波 郑劲平[1] 高怡[1] ZHONG Liping;WUZhongping;HUANG Ruibo;ZHENG Jinping;GAO Yi(The First Affiliated Hospital of Guangzhou Medical University/National Clinical Research Center of Respiratory Disease/State Key Laboratory of Respiratory Disease/Guangzhou Institute of Respiratory Health,Guangzhou 510120,China)

机构地区：[1]广州医科大学附属第一医院,国家呼吸系统疾病临床医学研究中心,呼吸疾病国家重点实验室,广州呼吸健康研究院,广东省广州市510120

出　　处：《中国全科医学》2021年第29期3664-3670,共7页Chinese General Practice

基　　金：国家重点研发计划(2018YFC1311900,2016YFC1304603);国家科技支撑计划(2015BAI12B10);浙江省重点研发计划(2020C03062)。

摘　　要：背景慢性呼吸系统疾病是影响我国居民健康的“四大慢性病”之一。肺功能检查是呼吸疾病诊治的适宜技术,被列入国家卫生健康规划与慢性病防治中长期规划。广大基层医疗机构逐步普及多种国产便携式肺功能仪器,但其检测性能有待科学验证。目的评价国产新型压差式肺量计优呼吸PF680的测量值及其可靠性。方法于2020年9—10月选取国产新型压差式肺量计优呼吸PF680(亿联康公司,浙江)作为实验组,进口Master Screen Pneumo肺量计(耶格公司,德国)作为对照组,每组2台。根据国际标准(ISO 26782:2009)中13个标准波形(C1~C13)使用标准流量/容积模拟器产生气源,测量用力肺活量(FVC)、第1秒用力呼气容积(FEV1)、呼气峰流速(PEF)、最大呼气中期流量(MMEF)、用力呼出50%肺活量时的瞬间呼气流量(FEF50%)和用力呼出75%肺活量时的瞬间呼气流量(FEF75%)等,评价实验仪器的技术性能并与对照组进行对比分析。结果容积准确性方面:实验组除了2号机C12波形的FVC以外,1号机和2号机其余波形FVC、FEV1的容积误差均≤±0.05 L或±3%;容积重复性方面:实验组两台仪器所有波形3次测试的最大差值均<0.05 L且<平均值的3%;线性度方面:实验组1号机和2号机分别有1、2个线性误差>3%,其余波形线性误差均符合要求;所有波形的气流阻抗<0.15 kPa·L^(-1)·s^(-1)。两组C5、C7~C8、C11~C12波形FVC比较,差异有统计学意义(P<0.05);两组C3、C5~C6、C8~C9、C11~C12波形FEV1比较,差异有统计学意义(P<0.05);两组C1~C10、C13波形PEF比较,差异有统计学意义(P<0.05);两组C1~C11、C13波形MMEF比较,差异有统计学意义(P<0.05);两组C1、C3~C11、C13波形FEF50%比较,差异有统计学意义(P<0.05);两组C1~C12波形FEF75%比较,差异有统计学意义(P<0.05);总体13个波形两组测量值进行比较,MMEF、FEF50%、FEF75%差异有统计学意义(P<0.05)。Bland-Altman散点图显示,FVC、FEV1、PEF、FEF50%均有92Background As an appropriate approach facilitating the diagnosis and treatment of respiratory disease,one of the four major diseases in China,pulmonary function test has been included in the national health plan and the long-term plan for the prevention and treatment of chronic diseases.A variety of domestically-made portable spirometers have been widely used in primary healthcare,but their performance needs to be scientifically verified.Objective To assess the performance of spirometer PF680,a new domestically-made spirometer based on differential pressure sensing.Methods This study was conducted from September to October 2020.A comparative analysis was performed between spirometer PF680(produced by e-Link Care Meditech Co.,Ltd.,Zhejiang,China,n=2,experimental group)and Master Screen Pneumo spirometer(produced by Jaeger,Germany,n=2,control group)in terms of performance indicators〔forced vital capacity(FVC),forced expiratory volume in one second(FEV1),peak expiratory flow(PEF),maximal mid-expiratory flow(MMEF),forced expiratory flow at 50%of vital capacity(FEF50%),forced expiratory flow at 75%of vital capacity(FEF75%)〕generated by the standard flow/volume simulator,which was applied according to 13 standard waveforms(C1-C13)in the ISO 26782:2009.Results As for accuracy,in the experimental group,except for FVC of the C12 waveform measured by No.2 spirometer,the errors of the FVC of the other 25 waveforms and the FEV1 of the 26 waveforms measured by two spirometers were all≤±0.05 L or±3%.In terms of repeatabilities,the maximal differences between the values of FVC and FEV1measured for three times by the two spirometers in the experimental group were<0.05 L and<3%of the average value.With regard to linearity,in the experimental group,except for the C5 waveform FVC of the No.2 spirometerand the C5 waveform FVC and FEV1 of the No.1 spirometer,the waveform linearity errors of the remaining FVC and FEV1 measured by the two spirometers were within a permissible range.The impedance for all respiratory airflow wave

关 键 词：肺疾病 呼吸系统 压差式-肺量计 标准模拟器 准确性 重复性 线性 

分 类 号：R563[医药卫生—呼吸系统]