Nolly Hector, Romero Marcelo, Nolly Alejandro, Osso Pablo, Reinoso Omar, Nolly Mariela
Hypertension Center, Mendoza,
Blood Press Monit. 2004 Feb;9(1):53-8. doi: 10.1097/00126097-200402000-00010.
The Sixth Report of the Joint National Committee states that the 'measurement of blood pressure outside the clinician's office may provide valuable information for the initial evaluation of patients with hypertension and for monitoring the response to treatment'. Prior to their marketing, however, blood pressure measuring devices should be independently validated for safety and accuracy using standard guidelines.
The main objective of the present study was the clinical evaluation of the Braun Precision Sensor 2550 upgrade (Braun BP 2550 (UG)) according to the International Protocol of the European Society of Hypertension (ESH).
Measurements of systolic and diastolic blood pressure in 33 subjects were obtained using the mercury sphygmomanometer (Baumanometer) and the device. The sizes of the cuffs used for different arm circumferences were 12 x 23 cm, 15 x 33 cm and 18 x 36 cm for the thin adult, adult and overweight adult, respectively. The adult size was mostly used. If the cuff of the sphygmomanometer did not fall between the two range lines, a larger or smaller cuff was required. The reproducibility of self-blood pressure measurement was compared in 33 subjects (99 measurements). Nine sequential same-arm measurements comparing the test device and the standard mercury sphygmomanometer were carried out according to the International Protocol of the ESH in three steps (phases 1, 2.1 and 2.2).
The device passed phases 1 and 2.1 as 75 systolic and 78 diastolic readings fell within 5 mmHg, exceeding the total of 65 required for approval. It also passed phase 2.2 as 30 subjects for systolic and 29 for diastolic had at least two out of three comparisons within 5 mmHg, exceeding the 22 subjects required. The difference-against-mean plots showed that the device-sphygmomanometer disagreement was -1.58+/-4.84 for systolic pressure (the Braun being lower) and +2.23+/-3.84 for diastolic pressure (the Braun being higher), respectively.
The equipment passed both phases of the International Protocol (subject measurements and subject accuracy). The difference of 0-5 mmHg between the sphygmomanometer and the device represents 'measurements considered to be very accurate and with no error of clinical relevance'. It can therefore be used at home as an adjunct to physicians' effort to control blood pressure in their hypertensive patients.
美国国家联合委员会第六次报告指出，“在临床医生办公室以外测量血压可为高血压患者的初始评估及监测治疗反应提供有价值的信息”。然而，在血压测量设备上市之前，应使用标准指南对其安全性和准确性进行独立验证。
本研究的主要目的是根据欧洲高血压学会（ESH）的国际协议对博朗精密传感器2550升级版（博朗BP 2550（UG））进行临床评估。
使用汞柱式血压计（鲍曼血压计）和该设备对33名受试者的收缩压和舒张压进行测量。对于不同臂围的受试者，所用袖带尺寸分别为：瘦成年人12×23厘米、成年人15×33厘米、超重成年人18×36厘米。大多使用成年人尺寸的袖带。如果血压计的袖带不在两条范围线之间，则需要更换更大或更小的袖带。在33名受试者中比较了自测血压的重复性（共99次测量）。根据ESH的国际协议分三个步骤（阶段1、2.1和2.2）对测试设备和标准汞柱式血压计进行了九次连续的同臂测量。
该设备通过了阶段1和2.1，因为75次收缩压读数和78次舒张压读数落在5 mmHg范围内，超过了批准所需的65次的总数。它也通过了阶段2.2，因为收缩压有30名受试者、舒张压有29名受试者在三次比较中有至少两次在5 mmHg范围内，超过了所需的22名受试者。差值-均值图显示，该设备与血压计在收缩压上的差异为-1.58±4.84（博朗血压计读数较低），在舒张压上的差异为+2.23±3.84（博朗血压计读数较高）。
该设备通过了国际协议的两个阶段（受试者测量和受试者准确性）。血压计与该设备之间0至5 mmHg的差异代表“被认为非常准确且无临床相关误差的测量结果”。因此，它可在家中使用，作为医生控制高血压患者血压的辅助手段。
