根据2010年修订版欧洲高血压学会国际 protocol 对SCIAN LD - 735腕式血压监测仪进行家庭血压监测的验证。

Validation of the SCIAN LD-735 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

作者信息

Kang Yuan-Yuan, Chen Qi, Li Yan, Wang Ji-Guang

机构信息

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.

出版信息

Blood Press Monit. 2016 Aug;21(4):255-8. doi: 10.1097/MBP.0000000000000192.

DOI:10.1097/MBP.0000000000000192

PMID:27093702

Abstract

OBJECTIVE

This study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor SCIAN LD-735 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010.

METHODS

Systolic and diastolic blood pressures were measured sequentially in 33 adult Chinese participants (10 women, mean age 44.8 years) using a mercury sphygmomanometer (two observers) and the SCIAN LD-735 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases.

RESULTS

The SCIAN LD-735 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 86/99, 97/99, and 98/99, respectively, for systolic blood pressure and 85/99, 98/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. In total, 30 and 33 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). No participant had all of the three device-observer comparisons greater than 5 mmHg for systolic or diastolic blood pressure.

CONCLUSION

The SCIAN wrist blood pressure monitor LD-735 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

摘要

目的

本研究旨在根据欧洲高血压学会2010年修订版的国际协议，评估自动示波腕式血压监测仪SCIAN LD - 735用于家庭血压监测的准确性。

方法

使用汞柱式血压计（两名观察者）和SCIAN LD - 735设备（一名监督者），对33名成年中国参与者（10名女性，平均年龄44.8岁）依次测量收缩压和舒张压。从33名参与者中总共获得99对比较数据，分两部分进行判断，有三个分级阶段。

结果

SCIAN LD - 735设备在验证研究的第一部分达到了目标。对于收缩压，设备与观察者之间绝对差值在5、10和15 mmHg以内的数量分别为86/99、97/99和98/99；对于舒张压，分别为85/99、98/99和99/99。该设备在验证研究的第二部分也符合标准。收缩压和舒张压分别有30名和33名参与者，其设备与观察者的三个差值中至少有两个在5 mmHg以内（要求≥24）。没有参与者的收缩压或舒张压的所有三个设备与观察者比较值都大于5 mmHg。