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根据欧洲高血压学会方案开发和验证一种盲法混合设备:日机装 DM-3000。

Development and validation of a blinded hybrid device according to the European Hypertension Society protocol: Nissei DM-3000.

机构信息

King's College London, Maternal and Fetal Research Unit, Division of Reproduction and Endocrinology, St Thomas' Hospital, London, UK.

出版信息

J Hum Hypertens. 2010 Sep;24(9):609-16. doi: 10.1038/jhh.2009.113. Epub 2010 Jan 28.

DOI:10.1038/jhh.2009.113
PMID:20107491
Abstract

Both automated and auscultatory blood pressure (BP) devices have their strengths and accuracy limitations. Hybrid devices, such as the Nissei DM-3000, are mercury free and provide both automated and auscultatory measurement modes. The aim of this study was to validate all measurement modes of the Nissei DM-3000 device according to the European Society of Hypertension (ESH) protocol, as well as to develop and validate a 'blinded' auscultatory measurement mode. Different measurement modes were developed and evaluated in separate studies. Nine sequential same-arm BP measurements were taken alternating between simultaneous mercury sphygmomanometer readings and the device. The latter seven measurements were analysed according to the requirements of the ESH protocol. All measurement modes of the device passed the ESH protocol. The blinded mode achieved the best results with a mean difference+/-s.d. of -0.1+/-2.6 and 0.04+/-2.4 mm Hg for systolic BP (SBP) and diastolic BP (DBP), respectively. The most accurate auscultatory measurement results were obtained with a deflation rate of 2.5 mm Hg s(-1) achieving a mean difference+/-s.d. of -0.6+/-4.4 (for SBP) and -1.4+/-2.8 mm Hg (for DBP). The automated mode achieved a mean difference+/-s.d. of -0.8+/-6.0 (SBP) and 0.8+/-4.8 mm Hg (DBP). The Nissei DM-3000 device is a suitable replacement for the mercury sphygmomanometer.

摘要

自动和听诊式血压(BP)设备都有其优势和准确性限制。混合设备,如日机装 DM-3000,无汞且提供自动和听诊式测量模式。本研究的目的是根据欧洲高血压学会(ESH)方案验证日机装 DM-3000 设备的所有测量模式,并开发和验证一个“盲法”听诊式测量模式。不同的测量模式在单独的研究中进行了开发和评估。在同时进行汞柱血压计读数和设备测量的情况下,连续进行 9 次同侧臂 BP 测量,然后交替进行。后 7 次测量根据 ESH 方案的要求进行分析。设备的所有测量模式均通过 ESH 方案。盲法模式的结果最好,收缩压(SBP)和舒张压(DBP)的平均差值+/-标准差分别为-0.1+/-2.6 和 0.04+/-2.4 mmHg。以 2.5 mmHg/s 的降压速率获得最准确的听诊式测量结果,SBP 和 DBP 的平均差值+/-标准差分别为-0.6+/-4.4 和-1.4+/-2.8 mmHg。自动模式的平均差值+/-标准差为-0.8+/-6.0(SBP)和 0.8+/-4.8 mmHg(DBP)。日机装 DM-3000 设备是汞柱血压计的合适替代品。

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