Kang Yuan-Yuan, Chen Qi, Liu Chang-Yuan, Li Yan, Wang Ji-Guang
Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Blood Press Monit. 2018 Feb;23(1):45-48. doi: 10.1097/MBP.0000000000000296.
The aim of this study was to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor AVITA BPM64 for home BP monitoring according to the International Protocol of the European Society of Hypertension revision 2010.
Systolic and diastolic BPs were measured sequentially in 33 adult Chinese (14 women, mean age 47.0 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM64 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases.
The AVITA BPM64 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 91/99, 98/99, and 98/99, respectively, for systolic BP and 92/99, 99/99, and 99/99, respectively, for diastolic BP. The device also fulfilled the criteria in part 2 of the validation study. Thirty-two participants for both systolic and diastolic BP had at least two of the three device-observer differences within 5 mmHg (required ≥24). Only one participant for systolic BP had all three device-observer comparisons greater than 5 mmHg.
The AVITA upper arm BP monitor BPM64 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.
本研究旨在根据2010年修订的欧洲高血压学会国际协议，评估自动振荡式上臂血压（BP）监测仪AVITA BPM64用于家庭血压监测的准确性。
使用汞柱式血压计（两名观察者）和AVITA BPM64设备（一名监督者），对33名成年中国人（14名女性，平均年龄47.0岁）依次测量收缩压和舒张压。从33名参与者中总共获得了99对比较结果，用于分两部分、三个分级阶段进行判断。
AVITA BPM64设备在验证研究的第一部分达到了目标。对于收缩压，设备与观察者之间相差5、10和15 mmHg以内的绝对差值数量分别为91/99、98/99和98/99；对于舒张压，分别为92/99、99/99和99/99。该设备在验证研究的第二部分也符合标准。收缩压和舒张压方面，32名参与者在设备与观察者的差值中有至少两个在5 mmHg以内（要求≥24）。收缩压方面只有一名参与者的设备与观察者的所有三次比较差值均大于5 mmHg。
AVITA上臂血压监测仪BPM64已通过2010年修订版国际协议的要求，因此可推荐用于成人家庭使用。
