2种不同类型便携式肺量计的性能评价  

Performance analysis of two different types of portable spirometers

作　　者：吴仲平[1] 黄锐波 钟丽萍[1] 郑劲平[1] 高怡[1] WU Zhong-ping;HUANG Rui-bo;ZHONG Li-ping;ZHENG Jin-ping;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,广州510120

出　　处：《医疗卫生装备》2022年第10期56-61,共6页Chinese Medical Equipment Journal

基　　金：国家重点研发计划项目(2018YFC1311900,2016YFC1304603);国家科技支撑计划项目(2015BAI12B10)。

摘　　要：目的:对压差式和超声式2种类型的便携式肺量计的性能进行评价。方法:采用标准流量/容积模拟器在环境空气条件下输出ISO 26782:2009标准中定义的13条测试曲线(C1~C13)到10台不同品牌的便携式肺量计(3台超声式和7台压差式)中,测量第1秒用力呼气肺活量(forced expired volume in one second,FEV1)、第6秒用力呼气肺活量(forced expired volume in six seconds,FEV6)和用力呼气肺活量(forced vital capacity,FVC),并进行准确度、重复度、线性度、气流阻抗等分析。采用SPSS 21.0软件进行统计学分析,并采用Bland-Altman图评价2种肺量计的测量值与模拟器输出的标准值之间的一致性。结果:2种肺量计检测FEV1、FEV6、FVC的结果中,除了FEV1在C4曲线和FEV6在C12曲线中差异有统计学意义(P<0.05),其余均无统计学差异(P>0.05)。超声式肺量计的准确度、重复度、线性度和气流阻抗与ISO 26782:2009标准的符合率分别为33.33%、100%、100%、100%,压差式肺量计的准确度、重复度、线性度和气流阻抗与ISO 26782:2009标准的符合率分别为57.14%、100%、57.14%、57.14%,只有30.0%的肺量计指标均符合标准要求。所有肺量计检测FEV1、FEV6、FVC的一致性范围和临床可接受范围均尚可,超声式肺量计的一致性范围优于压差式肺量计,但2种肺量计的临床可接受范围接近。结论:2种肺量计的准确度虽存在一定的偏差,但重复度和一致性范围均符合标准要求。Objective To evaluate the performances of differential pressure and ultrasonic types of spirometers.Methods A standard flow/volume simulator was used to output the 13 test curves(C1 to C13)defined in ISO 26782:2009 standard to 10 portable spirometers of different brands(3 ultrasonic ones and 7 differential pressure ones)under ambient air conditions to measure forced expired volume in one second(FEV1),forced expired volume in six seconds(FEV6)and forced vital capacity(FVC)and to analyze the accuracy,repeatability,linearity and airflow impedance.Statistical analysis was carried out with SPSS 21.0 software,and the agreement between the measured values of the two spirometers and the standard values output by the simulator was evaluated with Bland-Altman plots.Results There were no statistically significant differences(P>0.05)among the results of FEV1,FEV6 and FVC detected by the 2 spirometers,except for FEV1 in the C4 curve and FEV6 in the C12 curve(P<0.05).The compliance rates with ISO 26782:2009 standard in accuracy,repeatability,linearity and airflow impedance were 33.33%,100%,100%and 100%respectively for the ultrasonic type of spirometer,and 57.14%,100%,57.14%and 57.14%for the differential pressure type of spirometer,with only 30.0%of the spirometers satisfying the requirements of the standard.All the spirometers had close clinically acceptable ranges,and the agreement ranges and clinically acceptable ranges for detecting FEV1,FEV6 and FVC met the requirements broadly,with the ultrasonic type spirometer gaining higher agreement range.Conclusion The two spirometers have the repeatability and agreement ranges meet the standard requirements,although there are some deviations in accuracy.

关 键 词：便携式肺量计 肺功能设备 压差式 超声式 标准流量/容积模拟器 性能评价 

分 类 号：R318.6[医药卫生—生物医学工程] TH776[医药卫生—基础医学]