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Validation of the Raycome model M2 ambulatory blood pressure monitor in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018). 根据医疗仪器促进协会/欧洲高血压学会/国际标准化组织通用标准(ISO 81060-2:2018),对普通人群中的瑞康 M2 型非卧床血压计进行验证。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-06-01 Epub Date: 2024-02-23 DOI: 10.1097/MBP.0000000000000697
Shijie Yang, Zhanyang Zhou, Huanhuan Miao, Hongye Zhang, Qiong Zhou, Mei Zhai, Yuqing Zhang

Objective: The aim of this study was to evaluate the accuracy of the Raycome model M2 oscillometric upper-arm blood pressure (BP) monitor developed for ambulatory BP measurement in the 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) at rest and during dynamic exercise.

Method: Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in the general population using the same arm sequential BP measurement method. Three cuffs of the test device were used for arm circumference 18-22 cm (small), 22-32 cm (medium) and 32-42 cm (large).

Results: For the general validation study, 106 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.5 ± 6.2/-0.2 ± 5.1 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.23/4.50 mmHg (systolic/diastolic). In the ambulatory validation study ( N  = 35), the mean difference was 0.4 ± 5.9/-1.1 ± 5.8 mmHg. The Raycome model M2 performed well against the standard in both the general and ambulatory validations and the Bland-Altman plots did not show any systematic variation in the error.

Conclusion: These data show that the Raycome model M2 monitor meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and in the ambulatory setting, indicating its suitability for measuring BP in the general population.

研究目的本研究旨在根据美国医学仪器促进协会/欧洲高血压学会/国际标准化组织(AAMI/ESH/ISO)通用标准(ISO 81060-2:2018),评估雷康 M2 型示波式上臂血压计在普通人群中进行静态和动态运动血压测量的准确性:在普通人群中招募符合 AAMI/ESH/ISO 通用标准的年龄、性别、血压和袖带分布标准的受试者,采用同臂顺序血压测量方法。测试设备的三个袖带分别适用于 18-22 厘米(小)、22-32 厘米(中)和 32-42 厘米(大)的臂围:在一般验证研究中,共招募了 106 名受试者,并对 85 名受试者进行了分析。就验证标准 1 而言,测试设备与参考血压读数之间差异的平均值(± SD)为 0.5 ± 6.2/-0.2 ± 5.1 mmHg(收缩压/舒张压)。对于标准 2,每个受试者的测试设备与参考血压之间的平均血压差异的 SD 值为 5.23/4.50 mmHg(收缩压/舒张压)。在流动验证研究中(N = 35),平均差异为 0.4 ± 5.9/-1.1 ± 5.8 mmHg。在一般和非卧床验证中,Raycome 模型 M2 与标准相比都表现良好,Bland-Altman 图显示误差没有任何系统性变化:这些数据表明,雷康 M2 型血压计符合 AAMI/ESH/ISO 通用标准 (ISO 81060-2:2018)的要求,并适用于非卧床环境,表明其适用于测量普通人群的血压。
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引用次数: 0
Microvascular abnormalities induced by hand-transmitted vibration reflects in finger systolic blood pressure: a cross-sectional study in China. 手部振动引起的微血管异常在手指收缩压中的反映:一项在中国进行的横断面研究。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-06-01 Epub Date: 2024-04-24 DOI: 10.1097/MBP.0000000000000695
Maosheng Yan, Hanjun Zheng, Qian Liu, Bin Xiao, Chengmin Wang, Yanxia Jia, Siyu Pan

Objective: Local vibration can cause microcirculatory abnormalities such as blood stasis and symmetrical intermittent digital artery vasospasm. Finger SBP (FSBP) measurement is a potential way of assessing vascular components. This study aims to comprehensively investigate the relationship between the occurrence of the vibration-induced white finger (VWF) and changes in FSBP and then set the application value of FSBP measurements in the early diagnosis of VWF.

Methods: All samples were judgmental sampling from one factory. Totally 50 patients with VWF were the case group, while 50 without occupational hand-transmitted vibration exposure were the control group. FSBP measurements and epidemiological feature investigations were taken.

Results: There were significant reductions in FSBP level and %FSBP index at both 10 °C and 30 °C in fingers reported VWF ( P  < 0.05). The %FSBP abnormal rate of the index, ring and little finger in the VWF group was higher than the control (44.00% vs. 18.00%, 78.00% vs. 26.00%, 64.00% vs. 8.00%). The %FSBP of the ring and little finger had a relatively high application value (area under curve = 0.902, 0.737), while their standard regression coefficients were -0.23 and -0.412. The diagnostic cutoff value of the ring finger was 77.60%, while the sensitivity and specificity were 86.67%.

Conclusion: FSBP measurements were proven helpful in monitoring and diagnosing VWF prospectively and proved to have great application value in our study. %FSBP of the ring finger was the appropriate diagnostic index in FSBP measurements, while its abnormal value could be set as 80.00%.

目的:局部振动可导致微循环异常,如血液淤滞和对称性间歇性数字动脉血管痉挛。测量手指SBP(FSBP)是评估血管成分的一种潜在方法。本研究旨在全面探讨振动诱发白指(VWF)的发生与 FSBP 变化之间的关系,进而确定 FSBP 测量在 VWF 早期诊断中的应用价值:所有样本均来自一家工厂的判断性抽样。方法:所有样本均来自一家工厂的判断性抽样,50 名 VWF 患者为病例组,50 名无职业性手传振动暴露的患者为对照组。测量 FSBP 并进行流行病学特征调查:结果:报告的 VWF 手指在 10 ℃ 和 30 ℃ 时 FSBP 水平和 %FSBP 指数均有明显降低(P 结论:FSBP 水平和 %FSBP 指数在 10 ℃ 和 30 ℃ 时均有明显降低:事实证明,FSBP 测量有助于前瞻性监测和诊断 VWF,在我们的研究中也证明了其巨大的应用价值。在 FSBP 测量中,无名指的 %FSBP 是合适的诊断指标,其异常值可设定为 80.00%。
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引用次数: 0
Validation of noninvasive blood pressure monitoring function of EDAN elite V5 patient monitor with reference invasive measurement according to the ISO 81060-2:2018 standard. 根据 ISO 81060-2:2018 标准验证 EDAN elite V5 患者监护仪的无创血压监测功能与有创测量参考值。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-06-01 Epub Date: 2024-04-24 DOI: 10.1097/MBP.0000000000000694
Yi Wan, Duan Li, Jin-Feng Chen, Yang Zhang

Objective: To validate the noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor with reference invasive blood pressure monitoring equipment for clinical use in adults, adolescents or children according to the International Organization for Standardization (ISO) 81060-2:2018 standard.

Methods: Patients were recruited, and the ipsilateral sequential method was used for blood pressure measurement according to the standard. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference invasive blood pressure results.

Results: A total of 71 patients were included in the study, with 35 and 36 patients for each iFAST and iCUFS mode, respectively. The validation results showed an average device-reference difference of -3.27 ± 5.60 mmHg for SBP and -0.09 ± 6.10 mmHg for DBP for the iFAST mode, and -2.04 ± 5.55 mmHg for SBP and -0.79 ± 5.86 mmHg for DBP for the iCUFS mode, respectively, which passed the criteria of the ISO 81060-2 : 2018 in adults, adolescents or children population for both SBP and DBP.

Conclusion: The noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor passed all the requirements of ISO 81060-2:2018 and can be recommended for clinical use in adults, adolescents, or children.

目的:根据国际标准化组织(ISO)81060-2:2018 标准,验证 EDAN elite V5 患者监护仪的无创血压监测功能与成人、青少年或儿童临床使用的有创血压监测设备的参考性:招募患者,根据标准采用同侧顺序法测量血压。按照方案对验证结果进行评估,并使用Bland-Altman散点图显示测试设备与参考有创血压结果之间的差异:共有 71 名患者参与了研究,iFAST 和 iCUFS 模式分别有 35 名和 36 名患者。验证结果显示,iFAST 模式的 SBP 和 DBP 平均设备与参考值的差值分别为 -3.27 ± 5.60 mmHg 和 -0.09 ± 6.10 mmHg;iCUFS 模式的 SBP 和 DBP 平均设备与参考值的差值分别为 -2.04 ± 5.55 mmHg 和 -0.79 ± 5.86 mmHg:EDAN elite V5 患者监护仪的无创血压监测功能通过了 ISO 81060-2:2018 的所有要求,可推荐用于成人、青少年或儿童的临床使用。
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引用次数: 0
Accuracy of the KOROT P3 Accurate automated auscultatory blood pressure measuring device for professional use in people with extra-large arms. KOROT P3 精确自动听诊式血压测量仪的准确性,适用于手臂特大的专业人士。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-06-01 Epub Date: 2024-02-23 DOI: 10.1097/MBP.0000000000000696
Claudio Fania, Antonella Giletto, Alice Niero, Paolo Palatini

Objective: To determine the accuracy of the KOROT P3 Accurate (previously InBody BPBIO480KV) monitor, an automated auscultatory blood pressure (BP) measuring device developed for professional use, in people with extra-large arms according to the ISO81060-2 2018 protocol.

Methods: The KOROT P3 Accurate was tested in 37 subjects with upper-arm circumference ranging from >42 to 53 cm using a mercury sphygmomanometer coupled to a 20 × 40 cm tronco-conical cuff as the reference standard.

Results: The mean BP difference between the device and the observers' reference measurements was 1.2 ± 2.0 mmHg for systolic BP and 1.0 ± 2.0 mmHg for diastolic BP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Also criterion 2 was satisfied being the standard deviations ± 1.7 mmHg for systolic BP and ± 1.6 for diastolic BP, well below the maximum values required by the protocol (±6.84/6.87 mmHg). Scatterplots of device-reference systolic and diastolic BP differences showed similar accuracy across the range of participants' BP, arm circumference and upper-arm slant angle.

Conclusions: These data show that the KOROT P3 Accurate monitor satisfied the ISO 81060-2:2018 standard requirements in a special population of people with extra-large arms ranging from >42 to 53 cm.

目的根据 ISO81060-2 2018 协议,确定 KOROT P3 Accurate(前身为 InBody BPBIO480KV)监测仪(一款专为专业用途开发的自动听诊式血压(BP)测量设备)在超大臂人群中的准确性:使用水银血压计和 20 × 40 厘米锥形袖带作为参考标准,对 37 名上臂周长大于 42 厘米至 53 厘米的受试者进行了 KOROT P3 Accurate 测试:设备与观察者参考测量值之间的平均血压差为:收缩压 1.2 ± 2.0 mmHg,舒张压 1.0 ± 2.0 mmHg。这些数据符合方案标准要求的标准 1(≤5 ± 8 mmHg)。此外,标准 2 也符合,收缩压的标准偏差为 ± 1.7 mmHg,舒张压的标准偏差为 ± 1.6 mmHg,远低于方案要求的最大值(±6.84/6.87 mmHg)。设备参考收缩压和舒张压差异的散点图显示,在参与者的血压、臂围和上臂斜角范围内,其准确性相似:这些数据表明,KOROT P3 Accurate 监护仪符合 ISO 81060-2:2018 标准的要求,适用于臂围大于 42 厘米至 53 厘米的特大臂人群。
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引用次数: 0
Validation of the DBP-1333b upper-arm blood pressure monitor according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020). 根据 AAMI/ESH/ISO 通用标准(ISO 81060-2:2018+Amd.1:2020)验证 DBP-1333b 上臂式血压计。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-06-01 Epub Date: 2024-04-24 DOI: 10.1097/MBP.0000000000000688
Guocun Hou, Yulu Wu, Jiaying Wang, Jia Zhi

To evaluate the accuracy of the DBP-1333b upper-arm blood pressure (BP) measuring device in the adult population according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020). Subjects were recruited in the adult population. The test device was an arm-type electronic sphygmomanometer (DBP-1333b) and the reference device was a desktop sphygmomanometer (XJ11D). Using the BP data measured by the desktop sphygmomanometer as reference BP, the accuracy of the non-invasive BP module of the test device was evaluated to determine whether it met the requirements. Data from 90 individuals were analysed. According to Criterion 1, the mean difference of SBP between the test and reference device was 0.19 mmHg and the SD was 7.45 mmHg. The mean difference of DBP was -0.59 mmHg and the SD was 6.47 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, SD of SBP was 5.79 mmHg, which was less than 6.95 mmHg and met the requirements. The SD of DBP was 5.58 mmHg, which was less than 6.93 mmHg and met the requirements. It was concluded that the DBP-1333b complies with the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020) and can be recommended for use by the adults.

根据 AAMI/ESH/ISO 通用标准(ISO 81060-2:2018+Amd.1:2020),评估 DBP-1333b 上臂式血压(BP)测量仪在成年人群中的准确性。受试者从成年人群中招募。测试设备为臂式电子血压计(DBP-1333b),参照设备为台式血压计(XJ11D)。使用台式血压计测量的血压数据作为参考血压,对测试设备的无创血压模块的准确性进行评估,以确定其是否符合要求。对 90 人的数据进行了分析。根据标准 1,测试设备与参考设备之间的 SBP 平均差值为 0.19 mmHg,SD 为 7.45 mmHg。DBP 的平均差值为-0.59 毫米汞柱,标准差为 6.47 毫米汞柱。SBP 和 DBP 的平均差均小于 5 mmHg,标差小于 8 mmHg,符合要求。根据标准 2,SBP 的 SD 值为 5.79 mmHg,小于 6.95 mmHg,符合要求。DBP 的 SD 值为 5.58 mmHg,小于 6.93 mmHg,符合要求。结论是 DBP-1333b 符合 AAMI/ESH/ISO 通用标准(ISO 81060-2:2018+Amd.1:2020),可推荐成人使用。
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引用次数: 0
Automated office blood pressure measurement with the assistance of an instructional video in patients with hypertension. 在高血压患者指导视频的帮助下,自动办公室血压测量。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-04-01 Epub Date: 2023-11-15 DOI: 10.1097/MBP.0000000000000685
Ayumi Toba, Joji Ishikawa, Kazumasa Harada

Objectives: Automated office blood pressure (AOBP) measurement often requires assistance. Accompanied by an instructional video, AOBP measurement could be performed independently by patients.

Design and methods: Seventy-five patients with hypertension were enrolled. AOBP was measured three times at 1-min intervals after 5 min of rest by an automated BP measurement device with the assistance of an animated instructional video. The video was designed originally to instruct patients on the way to measure BP appropriately. Perceived stress was evaluated using a questionnaire after the AOBP measurement. Office BP was measured three times using the same device. Home BP measurement was performed on 5 consecutive days.

Results: The mean age of the patients was 74.5 ± 10.6 years, and 96% were taking antihypertensive drugs. Mean AOBP, office BP and home BP measurements were 135.2 ± 17.2/81.3 ± 11.1, 139.3 ± 16.3/78.6 ± 10.9 and 129.2 ± 16.7/72.7 ± 8.9 mmHg, respectively. Regarding SBP, the mean AOBP was significantly lower than office BP ( P  = 0.005) and higher than home BP ( P  = 0.004). The differences in SBP and DBP between AOBP and home BP measurements were significantly related to patients' perceived stress when performing AOBP measurements ( r  = 0.289; P  = 0.013 and r  = 0.328; P  = 0.004). In a multivariate analysis, patients' perceived stress was a significant predictor of the difference between AOBP and home BP ( P  = 0.013), even after adjusting for age, sex, BMI and mean of AOBP and home BP.

Conclusion: AOBP values measured with the assistance of an instructional video were between conventional office and home BP measurements. Perceived stress during AOBP measurement was related to the difference in AOBP from home BP.

目的:自动化办公室血压(AOBP)测量通常需要辅助。伴随教学视频,AOBP测量可由患者独立进行。设计和方法:纳入75例高血压患者。在动画教学视频的辅助下,在休息5分钟后,用自动血压测量仪测量AOBP,每隔1分钟测量3次。该视频最初的目的是指导患者如何正确测量血压。感知压力在AOBP测量后使用问卷进行评估。使用相同的设备测量了三次办公室血压。连续5天进行家庭血压测量。结果:患者平均年龄为74.5±10.6岁,96%的患者正在服用降压药。平均AOBP、办公室血压和家庭血压分别为135.2±17.2/81.3±11.1、139.3±16.3/78.6±10.9和129.2±16.7/72.7±8.9 mmHg。收缩压方面,平均AOBP明显低于办公室血压(P = 0.005),高于家庭血压(P = 0.004)。AOBP和家庭血压测量的收缩压和舒张压差异与患者在进行AOBP测量时的感知压力显著相关(r = 0.289;P = 0.013, r = 0.328;p = 0.004)。在多变量分析中,即使在调整了年龄、性别、BMI和AOBP和家庭血压的平均值后,患者的感知压力是AOBP和家庭血压差异的显著预测因子(P = 0.013)。结论:在教学视频辅助下测量的AOBP值介于常规办公室和家庭血压测量值之间。测量AOBP时的感知压力与AOBP与家庭血压的差异有关。
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引用次数: 0
Validation of the ANDON KD-595 automated upper-arm blood pressure monitor according to the universal standard. 根据通用标准对 ANDON KD-595 自动上臂式血压计进行验证。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-04-01 Epub Date: 2023-12-14 DOI: 10.1097/MBP.0000000000000686
Kui Liu, Dan Wu, Sen Bing, Lin-Yi Li

Objective: To validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement blood pressure measurement according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard.

Methods: Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard.

Results: For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96 ± 5.35 and 0.82 ± 5.08 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64 mmHg (with maximum allowed SDs of 6.87 and 6.89 mmHg) for SBP and DBP, respectively.

Conclusion: The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population.

目的根据美国医学仪器促进协会/欧洲高血压学会/国际标准化组织(AAMI/ESH/ISO)通用标准,验证安东 KD-595 自动上臂式血压计在临床使用和自我血压测量中的有效性:方法:对 90 名合格的成人参与者连续测量相同的左臂血压,并与标准水银血压计进行比较。共获得 270 对对比数据,并根据通用标准进行分析:在通用标准的验证标准 1 中,测试设备与参考血压读数之间的差异平均值(± SD)分别为 0.96 ± 5.35 毫米汞柱(SBP)和 0.82 ± 5.08 毫米汞柱(DBP)。对于标准 2,每个受试者的测试设备和参考血压之间的平均血压差异的 SD 分别为 4.84 和 4.64 mmHg(最大允许 SD 为 6.87 和 6.89 mmHg):安东 KD-595 自动上臂式血压计通过了 AAMI/ESH/ISO 通用标准的所有验证要求,可推荐用于临床和普通人群的自我血压测量。
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引用次数: 0
Blood pressure responsiveness to resistance training in the hypertensive older adult: a randomized controlled study. 高血压老年人对阻力训练的血压反应:随机对照研究。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-04-01 Epub Date: 2024-01-15 DOI: 10.1097/MBP.0000000000000690
Odilon Abrahin, Rejane Pequeno Abrahin, Mayko Guimarães, Vitor Bruno Teixeira de Holanda, Fernanda Andreza De Pinho Lott Figueiredo, Bruno Viana Rosa, Ivo Vieira de Sousa Neto, Nicholas Rolnick, Gislane Ferreira de Melo, Emanuelle Fernandes Prestes, Dahan da Cunha Nascimento

Different lifestyle changes have been employed to improve clinical hypertension. However, there is scarce evidence on the blood pressure responsiveness to resistance training (RT) in hypertensive older adults. Consequently, little is known about some participants clinically reducing blood pressure and others not. Thus, we investigate the effects and responsiveness of RT on blood pressure in hypertensive older adults. We secondarily evaluated the biochemical risk factors for cardiovascular disease and functional performance. Older participants with hypertension were randomly assigned into RT (n = 27) and control group (n = 25). Blood pressure, functional performance (timed up and go, handgrip strength, biceps curl and sit-to-stand), fasting glucose, and lipid profiles were evaluated preintervention and postintervention. The statistic was performed in a single-blind manner, the statistician did not know who was the control and RT. RT was effective in reducing systolic blood pressure (SBP) (pre 135.7 ± 14.7; post 124.7 ± 11.0; P  < 0.001) and the responses to RT stimuli varied noticeably between hypertensive older adults after 12 weeks. For example, 13 and 1 responders displayed a minimal clinical important difference for SBP attenuation (10.9 mmHg) in the RT and control groups, respectively. RT improved the functional performance of older people with hypertension, while no differences were found in biochemical parameters (triglycerides, HDL, LDL, fasting glucose) after 12 weeks. In conclusion, responses to RT stimuli varied noticeably between hypertensive individuals and RT was effective in reducing SBP.

人们采用了不同的生活方式改变来改善临床高血压。然而,有关高血压老年人对阻力训练(RT)的血压反应的证据却很少。因此,人们对一些参与者能降低临床血压,而另一些则不能的情况知之甚少。因此,我们研究了阻力训练对高血压老年人血压的影响和反应性。其次,我们还评估了心血管疾病的生化风险因素和功能表现。患有高血压的老年人被随机分配到 RT 组(27 人)和对照组(25 人)。对干预前和干预后的血压、功能表现(计时起立、握力、二头肌卷曲和坐立)、空腹血糖和血脂情况进行了评估。统计以单盲方式进行,统计人员不知道谁是对照组,谁是 RT 组。RT 能有效降低收缩压(SBP)(干预前为 135.7 ± 14.7;干预后为 124.7 ± 11.0;P
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引用次数: 0
Analyzing key genetic and comorbid factors on the efficacy of digital therapeutics for treating high blood pressure. 分析数字疗法治疗高血压疗效的关键遗传和合并因素。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-04-01 Epub Date: 2024-02-28 DOI: 10.1097/MBP.0000000000000687
Jigar Patel, Hasan Zia, David F Lo
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引用次数: 0
Validation of the automated oscillometric upper-arm cuff home blood pressure monitor AVITA BPM82 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. 根据医学仪器进步协会/欧洲高血压学会/国际标准化组织(AAMI/ESH/ISO)通用标准,在普通人群中验证自动示波上臂套家用血压监测仪AVITA BPM82。
IF 1.3 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Pub Date : 2024-04-01 Epub Date: 2023-11-06 DOI: 10.1097/MBP.0000000000000682
Ariadni Menti, Vasileios Ntousopoulos, Aikaterini Theodosiadi, Panagiota Stathopoulou, Anastasios Kollias, George S Stergiou

Objective: This study evaluated the accuracy of the automated oscillometric upper-arm cuff device AVITA BPM82 intended 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 Amendment 1.2020-01.

Methods: Participants were recruited to fulfill the age, sex, blood pressure (BP), and limb distribution criteria of the AAMI/ESH/ISO Universal Standard and its Amendment 1.2020-01 in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-33 (medium) and 33-42 cm (large).

Results: One-hundred-one individuals were recruited and 85 were analyzed [mean age 57.3 ± 15.1 (SD) years, 46 men, arm circumference 32 ± 5.1 cm, range 22.3-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was 1.3 ± 6.5/3.6 ± 5.9 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 5.70/5.25 mmHg (systolic/diastolic; threshold ≤6.82/5.89 mmHg).

Conclusions: The automated oscillometric home BP monitor AVITA BPM82 comfortably fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01 in a general population and can be recommended for clinical use.

目的:本研究根据美国医疗器械进步协会/欧洲高血压学会/国际标准化组织(AAMI/ESH/ISO)通用标准(ISO 81060-2:2018)及其修正案,评估了适用于普通人群的自动示波上臂袖带装置AVITA BPM82的准确性1.2020-01方法:招募参与者,以满足AAMI/ESH/ISO通用标准及其修正案1.2020-01的年龄、性别、血压(BP)和肢体分布标准,在普通人群中使用相同的手臂顺序血压测量方法。测试装置的两个袖带用于手臂周长22-33(中等)和33-42 结果:共招募了101人,分析了85人[平均年龄57.3 ± 15.1(SD)岁,46名男性,臂围32 ± 5.1 cm,范围22.3-42 厘米]。对于验证标准1,试验装置和参考BP读数之间的平均差±SD(N = 255)为1.3 ± 6.5/3.6 ± 5.9 mmHg(收缩压/舒张压;阈值≤5 ± 8. mmHg)。对于标准2,每个个体的测试装置和参考BP之间的平均BP差的SD(N = 85)为5.70/5.25 mmHg(收缩/舒张;阈值≤6.82/5.89 结论:自动示波家用血压监测仪AVITA BPM82在普通人群中舒适地满足AAMI/ESH/ISO通用标准(ISO 81060-2:2018)及其修正案1.2020-01的所有要求,可推荐临床使用。
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Blood Pressure Monitoring
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