Abstract: Background　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 waveforms was <0.15 kPa•L-1•s-1. Compared with the single waveform of the control group，the FVC of C5，C7-C8 and C11-C12 waveforms demonstrated significantly differences between the two groups（P<0.05）. The FEV1 of C3，C5-C6，C8-C9 and C11-C12 waveforms differed significantly between the two groups （P<0.05）. The PEF of C1-C10 waveforms was significantly different between the two groups（P<0.05）. The PEF of C13 waveform was significantly different between the two groups（P<0.05）. The difference of C1-C11 and C13 waveform MMEF between the two groups was statistically significant（P<0.05）. The FEF50% of C1，C3-C11 and C13 waveforms between the two groups showed statistically significant differences （P<0.05）. The difference of C1-C12 waveform FEF75% between the two groups was statistically significant（P<0.05）. There were statistically significant differences in MMEF，FEF50% and FEF75% of the overall 13 waveforms between the two groups （P<0.05）. The Bland-Altman chart showed that FVC，FEV1，PEF，and FEF50% had 12 values （92.31%） and MMEF，and FEF75%had all values（100.00%）within the 95% confidence interval. The maximum absolute error for FVC，FEV1，PEF and FEF50% was 0.193 L，0.108 L，0.364 L/s，and 0.387 L/s，respectively. Conclusion　The spirometer PF680 has proved to be eligible for measuring pulmonary functions，and has good consistency with the German Jaeger spirometer，so it can be used for collectingreliable data clinically.

Key words: Lung diseases, Respiratory system, Differential pressure-spirometer, Standard simulator, Accuracy, Repeatability, Linearity

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92.31%（12/13）的点在95%CI之内，MMEF、FEF75%所有点（100.00%）在95%CI之内。FVC绝对误差最大值为0.193 L，FEV1绝对误差最大值为0.108 L，PEF绝对误差最大值为0.364 L/s，FEF50%绝对误差最大值为0.387 L/s。结论　国产新型压差式肺量计优呼吸PF680符合肺量计技术性能要求，与德国耶格肺量计一致性良好，可为临床提供可靠数据。

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