Reproducibility of home, ambulatory, and clinic blood pressure: Implications for the design of trials for the assessment of antihypertensive drug efficacy
Reproducibility of home, ambulatory, and clinic blood pressure: Implications for the design of trials for the assessment of antihypertensive drug efficacy
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DOI：
10.1016/s0895-7061(01)02324-x
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发表时间：
2002-02-01
影响因子：
3.2
通讯作者：
Mountokalakis, TD
中科院分区：
文献类型：
--
作者：
Stergiou, GS;Baibas, NM;Mountokalakis, TD
背景：本研究的目的是比较在诊所 (CBP)、在家 (HBP) 和动态监测 (ABP) 测量的血压 (BP) 的可重复性，并评估其对抗高血压药物试验准确性的影响。方法：通过重复测量 CBP（3 个月内 5 次就诊）、HBP（2 周内 6 个工作日）和 ABP，对总共 133 名未经治疗的 CBP 升高受试者进行评估（两次，间隔两周）。使用重复测量之间的差异标准差 (SDD) 对 CBP（1 次就诊）、HBP（2 天）和 ABP（24 小时）的重现性进行量化。针对每种测量方法计算了两种药物的比较试验所需的受试者人数。 结果：我们发现 HBP 提供最低的 SDD 值（收缩压/舒张压为 6.9/4.7 mm Hg，而 ABP 为 8.3/5.6，CBP 为 11.0/6.6）。对于一项旨在检测两种药物对 10 mm Hg 收缩压的效果差异的平行试验，使用 CBP 时需要 51 名受试者，而使用 ABP 需要 29 名受试者，使用 HBP 需要 20 名受试者（检测舒张压 5 mm Hg 差异分别需要 73、53 和 37 名受试者）。结论：该研究表明，与 CBP 和 CBP 相比，HBP 似乎具有更高的重现性。动态血压。此外，HBP还可以提高抗高血压药物试验的准确性，从而减少所需的样本量。 Am J Hypertens 2002；15:101-104 (C) 2002 美国高血压杂志有限公司。
Background: The aims of this study were to compare the reproducibility of blood pressure (BP) measured in the clinic (CBP), at home (HBP), and by ambulatory monitoring (ABP), and to assess its implications on the accuracy of antihypertensive drug trials.Methods: A total of 133 untreated subjects with elevated CBP were assessed with repeated measurements of CBP (five visits within 3 months), HBP (6 workdays within 2 weeks), and ABP (twice, 2 weeks apart). The reproducibility of CBP (one visit), HBP (2 days), and ABP (24 h) was quantified using the SD of differences (SDD) between repeated measurements. The number of subjects required in a comparative trial of two drugs was calculated for each measurement method.Results: We found that HBP provided the lowest SDD values (6.9/4.7 mm Hg, systolic/diastolic, compared with 8.3/5.6 for ABP and 11.0/6.6 for CBP). For a parallel trial aiming to detect a difference in the effect of two drugs of 10 mm Hg systolic BP, 51 subjects would be required when using CBP compared with 29 using ABP and 20 using HBP (73, 53 and 37 subjects, respectively, for the detection of a 5 mm Hg difference in diastolic BP).Conclusions: The study shows that HBP seems to have superior reproducibility compared with both CBP and ABP. In addition, HBP can improve the accuracy of antihypertensive drug trials, thereby reducing the sample size required. Am J Hypertens 2002;15:101-104 (C) 2002 American Journal of Hypertension, Ltd.