Beime Beate, Deutsch Cornelia, Krüger Ralf, Zimmermann Erik, Bramlage Peter
aInstitute for Pharmacology and Preventive Medicine, Cloppenburg bERKA Kallmeyer Medizintechnik, Bad Tölz, Germany.
Blood Press Monit. 2016 Dec;21(6):356-360. doi: 10.1097/MBP.0000000000000216.
The aim of the present study was to validate the blood pressure (BP) measurement device Erkameter 125 PRO according to the International Protocol revision 2010 of the European Society of Hypertension (ESH-IP2).
In 33 patients aged 32-79 years, BP measurements were performed alternately using the Erkameter 125 PRO and the reference mercury sphygmomanometer according to ESH-IP revision 2010. For the analysis, a total of 99 comparisons were included.
All absolute differences between the test device and the reference were within 10 mmHg for systolic blood pressure (SBP), and all except one for diastolic blood pressure (DBP). A total of 93 out of 99 comparisons for SBP showed an absolute difference within 5 mmHg and 92 out of 99 for DBP. The mean±SD difference between the Erkameter 125 PRO and the standard reference was -0.5±3.5 mmHg for SBP and 0.5±3.5 mmHg for DBP. As to part 2 of ESH-IP 2010, all patients had a minimum of two out of three measurements within 5 mmHg difference for SBP and 31 out of 33 patients for DBP.
The Erkameter 125 PRO fulfilled the requirements of parts 1 and 2 of the ESH-IP revision 2010 and can be recommended for office BP measurements in adults.
本研究旨在根据欧洲高血压学会2010年修订版国际协议(ESH-IP2)对血压测量设备Erkameter 125 PRO进行验证。
对33例年龄在32至79岁之间的患者,按照ESH-IP 2010修订版,交替使用Erkameter 125 PRO和参考汞柱式血压计进行血压测量。分析共纳入99次比较。
测试设备与参考设备之间的所有收缩压(SBP)绝对差值均在10 mmHg以内,舒张压(DBP)除一次外所有绝对差值也在10 mmHg以内。SBP的99次比较中共有93次绝对差值在5 mmHg以内,DBP的99次比较中有92次在5 mmHg以内。Erkameter 125 PRO与标准参考设备之间的平均±标准差差值,SBP为-0.5±3.5 mmHg,DBP为0.5±3.5 mmHg。关于ESH-IP 2010的第2部分,所有患者的SBP至少有三分之二的测量值差值在5 mmHg以内,DBP有33例患者中的31例满足此条件。
Erkameter 125 PRO符合ESH-IP 2010修订版第1部分和第2部分的要求,可推荐用于成人诊室血压测量。