Iglesias Bonilla P, Mayoral Sánchez E, Lapetra Peralta J, Iborra Oquendo M, Villalba Alcalá F, Cayuela Domínguez A
Unidad Docente de Medicina Familiar y Comunitaria de Sevilla. Hospital Universitario Virgen del Rocio. Sevilla. Spain.
Aten Primaria. 2002 Jun 15;30(1):22-8. doi: 10.1016/s0212-6567(02)78959-2.
Objective. To validate two monitors on the market for self-measurement of blood pressure (SMBP), an automatic one (OMRON HEM-705 CP) and a semi-automatic one (OMRON M1).Design. Descriptive study of validation of diagnostic tests.Setting. Primary care. San Pablo University Health Centre, Sevilla.Participants. 85 individuals (20 men and 65 women) with a wide range of age and blood pressure (BP), belonging to the population attended at the health centre or to its staff. People with arrhythmia and Korotkoff's V phase close to zero were excluded. Main measurements and results. BP and cardiac frequency (CF) measurements obtained with the SMBP devices to be validated were compared with readings on a mercury sphygmomanometer, used as the standard method. The differences between the SMBP devices and the gold standard were quantified and are presented on the scale proposed by the protocol of the British Hypertension Society (BHS). The mean (SD) of the systolic BP differences (in mm Hg) between the devices evaluated and the standard device was 1.084.73 for the automatic monitor and 1.255.30 for the semi-automatic one. The mean differences of diastolic BP were 0.444.03 for the automatic monitor, and 0.513.90 for the semi-automatic one. The cumulative percentage differences of systolic/ diastolic BP5, 10 and 15 mm Hg were 85.5, 98, 98.8/90.6, 98.4, 100% for the automatic monitor and 82.7, 95.7, 98.8/91, 99.6, 100% for the semi-automatic one. This supposes a Grade A on the BHS procedure, which is maintained on analysis of the results by blood pressure rankings. Conclusion. As both monitors meet the internationally accepted validation criteria, they can be recommended for the monitoring and self-monitoring of BP in patients with hypertension.
目的。验证市面上两款用于自测血压（SMBP）的监测仪，一款自动监测仪（欧姆龙HEM - 705 CP）和一款半自动监测仪（欧姆龙M1）。
设计。诊断试验验证的描述性研究。
地点。初级保健。塞维利亚圣巴勃罗大学健康中心。
参与者。85名个体（20名男性和65名女性），年龄和血压（BP）范围广泛，来自健康中心就诊人群或其工作人员。排除有心律失常和柯氏音V相接近零的人群。
主要测量指标和结果。将待验证的SMBP设备测得的血压和心率（CF）测量值与作为标准方法的汞柱式血压计读数进行比较。对SMBP设备与金标准之间的差异进行量化，并按照英国高血压学会（BHS）方案提出的量表呈现。评估设备与标准设备之间收缩压差异（以毫米汞柱为单位）的均值（标准差），自动监测仪为1.08±4.73，半自动监测仪为1.25±5.30。自动监测仪舒张压的均值差异为0.44±4.03，半自动监测仪为0.51±3.90。收缩压/舒张压相差5、10和15毫米汞柱时的累积百分比差异，自动监测仪分别为85.5%、98%、98.8%/90.6%、98.4%、100%，半自动监测仪分别为82.7%、95.7%、98.8%/91%、99.6%、100%。这在BHS程序中相当于A级，按血压分级分析结果时维持该等级。
结论。由于两款监测仪均符合国际认可的验证标准，可推荐用于高血压患者的血压监测和自我监测。
