Blood Pressure Monitoring最新文献

Objective: This study evaluated the accuracy of the automated oscillometric upper-arm cuff blood pressure (BP) device Microlife BP3KT1-4X (BP B3 Comfort PC) for home use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) and its amendments (1:2020 and 2:2024).

Methods: Participants were recruited to fulfill the age, sex, BP, and arm distribution criteria of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its amendments (1:2020 and 2:2024) in a general population using the same arm sequential measurement method. A single wide-range cuff of the test device was used for arm circumference 22-42 cm.

Results: A total of 122 individuals were recruited, and 85 were analyzed [mean age 54.5 ± 15.7 (SD) years, 34 men (40%), arm circumference 31.6 ± 5.4 cm, range 22.8-41.8 cm]. For validation criterion 1, the mean difference ± SD between the test device and reference BP readings ( N  = 255) was -0.1 ± 7.5/-2.3 ± 5.3 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual ( N  = 85) was 6.36/4.71 mmHg (systolic/diastolic; threshold ≤6.95/6.55 mmHg).

Conclusion: The automated oscillometric home BP monitor Microlife BP3KT1-4X (BP B3 Comfort PC) fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its amendments (1:2020 and 2:2024) in a general population and therefore can be recommended for self-monitoring of BP at home.

Home blood pressure monitoring (HBPM) is a valuable tool in the diagnosis and management of hypertension; however, patients often perform inaccurate measurements because of inadequate technique, which may lead to adverse health outcomes. This scoping review aimed to map the errors and negative outcomes associated with HBPM in individuals with hypertension. This scoping review was conducted in accordance with the Joanna Briggs Institute methodology. Fifteen databases were searched from April to May 2025. The review included primary studies, literature reviews, theses, and dissertations that addressed errors and negative outcomes of HBPM. Independent researchers assessed eligibility and performed data extraction. The data were analyzed descriptively. The search yielded 18 391 studies, 14 of which met the inclusion criteria. In total, 35 distinct HBPM errors were identified. The most prevalent errors reported were failure to follow the recommended number or schedule for daily blood pressure (BP) measurements (57.14%), failure to support the back during measurement (35.71%), inadequate interval between meals or coffee consumption and BP measurement (35.71%), talking during measurement (35.71%) and failure to record the measured BP values (35.71%). The most frequently cited negative outcomes were anxiety, uncontrolled hypertension, self-medication, and an increased number of unplanned emergency room visits (40.0% each). This review highlights that many patients with hypertension perform HBPM inaccurately, committing errors that can be mitigated with professional guidance during consultations. Therefore, healthcare professionals and services must dedicate efforts to properly train and empower patients in the correct execution of this procedure.

Objective: Recent guidelines recommend measuring blood pressure (BP) multiple times and averaging the results. The direction of the discrepancy between the first and second readings varies. This study aimed to examine whether directionality is associated with vascular aging indicators.

Methods: 43 807 participants who underwent health checkups were first stratified by average systolic BP (SBP < 120, 120-129, 130-139, or ≥140 mmHg) and diastolic BP (DBP < 80, 80-89, or ≥90 mmHg). They were then categorized into three groups based on the absolute difference between the first and second BP readings (ΔBP): ΔBP < 5 mmHg (group A), 5-9 mmHg (group B), and greater than or equal to 10 mmHg (group C). Clinical parameters and vascular aging markers were compared between groups.

Results: In participants with SBP less than 130 mmHg or DBP less than 80 mmHg, the first BP reading tended to be lower than the second. In contrast, among those with SBP greater than or equal to 130 mmHg or DBP greater than or equal to 90 mmHg, the first reading was often higher. Group C showed a significantly higher prevalence of hypertension, obesity, diabetes, and dyslipidemia, along with increased brachial-ankle pulse wave velocity and maximum carotid intima-media thickness.

Conclusion: The direction and magnitude of the discrepancy between the first and second BP measurements may reflect the underlying vascular aging. BP discrepancy patterns could serve as simple, noninvasive indicators of subclinical atherosclerosis.

Background: Despite adequate blood pressure control, many hypertensive patients remain at risk of cardiocerebral events. This study investigated the relationship between antihypertensive treatment intensity score (TIS) and interankle diastolic blood pressure difference (dIAND), and their utility in risk stratification.

Methods: We analyzed 368 patients with well-controlled hypertension (24-hour ambulatory blood pressure monitoring ≤ 130/80 mmHg), and pre-existing cardiovascular disease. Patients were stratified by median TIS (0.625) into low (TIS1) and high (TIS2) intensity groups. dIAND was calculated as the absolute difference in diastolic pressure between ankles. Patients were followed for 3 years for adverse cardiocerebral events.

Results: During follow-up (median 36 months), 73 major events were documented. The high TIS group exhibited significantly higher event rates (25.8 vs. 14.6%, log-rank P = 0.021), and remained an independent predictor after multivariable adjustment [adjusted hazard ratio: 1.92, 95% confidence interval (CI): 1.07-3.45, P  = 0.027]. A modest correlation was observed between TIS and dIAND ( r  = 0.26, P  < 0.001). Patients with dIAND ≥15 mmHg had higher event rates (35.0 vs. 18.0%; P  = 0.015); this association was attenuated in multivariable models. Notably, the combination of high TIS and elevated dIAND identified a subgroup with a 3.22-fold increased risk (adjusted hazard ratio: 3.22, 95% CI: 1.51-6.85, P  = 0.002) compared with the reference group (TIS ≤ 0.625 and dIAND < 15 mmHg).

Conclusion: TIS independently predicts cardiocerebral risk and correlates with dIAND. The combined assessment may refine risk stratification in controlled hypertension, offering a practical approach to identify high-risk patients requiring intensified management.

Objective: This study aimed to evaluate the efficacy of nifedipine combined with magnesium sulfate in pregnant women with gestational hypertension (GH) and its influence on blood lipid levels.

Methods: Seventy pregnant women with GH were randomly assigned to either a control group (labetalol plus magnesium sulfate) or an observation group (nifedipine extended-release tablets plus magnesium sulfate) ( n  = 35). Both groups were treated for 7 days. Posttreatment, changes in blood pressure (SBP and DBP), hemorheological parameters [whole blood high-shear viscosity, low-shear viscosity, plasma viscosity (PV)], blood lipid levels [high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and total cholesterol (TC)], adverse reactions, and pregnancy outcomes were assessed.

Results: Posttreatment, both groups showed significant reductions in SBP and DBP, with greater decreases in the observation group ( P  < 0.05). After 7 days of treatment, whole blood high-shear viscosity, low-shear viscosity, and PV decreased in both groups, with lower values for these in the observation group ( P  < 0.05). Lipid profiles improved in both groups, with the observation group showing higher HDL-C and lower LDL-C, TG, and TC ( P  < 0.05). The observation group had a higher overall efficacy rate (94.29 vs. 77.14%, P  < 0.05) and fewer adverse pregnancy outcomes (8.57% vs. 28.57%, P  < 0.05), while the incidence of adverse reactions was comparable between groups.

Conclusion: Nifedipine combined with magnesium sulfate is more effective in managing GH. This regimen better improves blood pressure, hemorheological parameters, lipid profiles, and pregnancy outcomes, with good safety.

Objective: The aim of this study was to validate the BTL ambulatory blood pressure monitoring NG ambulatory blood pressure (BP) monitoring device in a general population, including children aged 4-12 years, according to the International Organization for Standardization 81060-2:2018 standard with amendments A1:2020 and A2:2024.

Methods: The study included both clinical and ambulatory validation. In the clinical part, 85 participants (50 adults and 35 children) underwent same-arm sequential measurements with alternating test device and reference readings. The ambulatory part involved 35 adults tested using a dynamic protocol on a bicycle ergometer with at least a 15% heart rate increase. All procedures strictly followed standard requirements, including arm circumference and BP distributions.

Results: The device met all validation criteria defined by the standard. In clinical testing, mean differences were -0.52 mmHg systolic and -0.39 mmHg diastolic, with standard deviations of 4.44 and 4.17 mmHg. All cuff subgroups also met criterion 1, and criterion 2 was fulfilled with standard deviations of 3.80 mmHg systolic and 3.35 mmHg diastolic, including the children subgroup. In the ambulatory validation, mean differences were -0.40 mmHg systolic and -0.50 mmHg diastolic, with standard deviations of 5.88 and 5.05 mmHg.

Conclusion: To our knowledge, this is the first published validation of an ambulatory BP monitoring device that fully followed the unified 81060-2:2018 standard, including amendments A1:2020 and A2:2024. The device fulfilled all clinical and ambulatory validation criteria across all required distributions and age groups, including children.

Objective: To evaluate the accuracy of the automated oscillometric upper-arm cuff blood pressure (BP) monitor Microlife BP3KV1-5X (BP B6 Connect) for home use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) and its amendments (1:2020 and 2:2024).

Methods: Participants were recruited to fulfill the age, sex, BP, and arm distribution criteria of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its amendments (1:2020 and 2:2024) in a general population using the same arm sequential measurement method. A single wide-range cuff of the test device was used for arm circumference 22-42 cm.

Results: One-hundred and twenty individuals were recruited and 85 were analyzed [mean age: 55.8 ± 15.6 (SD) years, 41 men, arm circumference 31.9 ± 5.1 cm, range: 23-41.8 cm]. For validation criterion 1, the mean difference ± SD between the test device and reference BP readings ( N  = 255) was -0.8 ± 6.8/-2.3 ± 4.9 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual ( N  = 85) was 5.99/4.35 mmHg (systolic/diastolic; threshold ≤ 6.89/6.55 mmHg).

Conclusion: The automated oscillometric home BP monitor Microlife BP3KV1-5X (B6 Connect) fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its amendments (1:2020 and 2:2024) in a general population and can be recommended for home use.

To evaluate the accuracy of the DBP-6279B arm-type fully automatic digital blood pressure monitor in pregnant populations according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018/AMD 1:2020) and the Recognized Consensus Standards published by the Food and Drug Administration (FR Recognized List No.056, FR Recognized No. 3-166), a total of 115 pregnant women were enrolled in this clinical trial. One participant was excluded because it met the data exclusion criteria. The arm circumference and subgroup distributions of the subjects met the requirements of the protocol. According to criterion 1, the mean difference of systolic blood pressure between the test device and the reference device was ‑0.89 mmHg, with a SD of 5.60 mmHg. The mean difference of diastolic blood pressure was ‑0.17 mmHg, with a SD of 4.65 mmHg. The mean difference in both systolic and diastolic blood pressure was less than 5.0 mmHg, and the SD was less than 8.0 mmHg. Additional analyses were also conducted in accordance with criterion 2 and the results met the requirements, too. Therefore, it is recommended for pregnant populations in home and clinical use.

Accurate blood pressure (BP) measurement is essential for effective health management. To ensure this, international standards for the validation of BP monitors have been established and revised over time, with ISO 81060-2:2018 being the most recent. While many studies have been published evaluating the accuracy of BP monitors based on this standard, we identified concerns regarding the reliability of some reported results and therefore conducted a comprehensive literature review. Using ISO 81060-2:2018 as the validation framework, we extracted relevant studies from PubMed and collected the SD values for criterion 1 to compare and analyze the reported measurement accuracy. While most SD values ranged from 5 to 8%, we identified six studies reporting values below 4%. On the basis of our experience, such low variability is highly implausible and raises questions about the credibility of these findings. Reports claiming exceptionally high measurement accuracy with unusually low SD values may lead to misconceptions and could potentially be misused for marketing purposes. Therefore, validation studies must be conducted in strict adherence to medical ethics. In addition, there is a need to raise awareness that the current international standards for BP monitor validation require further refinement.

This study evaluated the accuracy of the automated oscillometric upper-arm cuff blood pressure (BP) measuring device Prolife PA5 Comfort AF (BP 136A) for home use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2 : 2018) and its amendments (1 : 2020 and 2 : 2024). The requirements of the Universal Standardand its amendments for a validation study in a general population using the same arm sequential measurement method were applied. Participants were recruited to fulfill the age, sex, BP level, arm circumference, and cuff size distribution criteria. The test device measures BP during inflation and uses a wide-range cuff for arm circumference 22-42 cm. One-hundred-twenty-eight individuals were recruited and 85 were analyzed [mean age: 54.9 ± 15.0 (SD) years, 36 (42%) men, arm circumference: 31.7 ± 5.4 cm, range: 22.5-41.9 cm). For validation Criterion 1, the mean difference ± SD between the test device and reference BP readings (N = 255) was -2.1 ± 7.5/-0.3 ± 5.3 mmHg (systolic/diastolic; threshold: ≤5 ± 8 mmHg). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual (N = 85) were 6.44/5.07 mmHg (systolic/diastolic; threshold: ≤6.62/6.95 mmHg). The automated oscillometric home BP monitor Prolife PA5 Comfort AF (BP 136A) fulfills all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its amendments (1 : 2020 and 2 : 2024) for a general population and can be recommended for clinical use.