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动态血压监测在抗高血压药物临床试验的患者选择、剂量调整和疗效评估中可发挥不可或缺的作用。

Ambulatory blood pressure monitoring can play an integral role in patient selection, dosage adjustment and efficacy assessment in clinical trials of antihypertensive agents.

作者信息

Canter D A, Texter M J, McLain R W

机构信息

Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company, Inc., Ann Arbor, Michigan 48105, USA.

出版信息

J Hypertens Suppl. 1994;12(7):S33-8.

PMID:7769502
Abstract

OBJECTIVE

To evaluate the efficacy and duration of action of the angiotensin converting enzyme inhibitor quinapril hydrochloride by using ambulatory blood pressure monitoring.

DESIGN

Eleven centers in the USA and Canada entered 155 patients with previously diagnosed hypertension into a 4-week placebo-baseline phase. Twenty patients (13%) with elevated diastolic blood pressure (DBP) only by cuff measurement were excluded from entry into a double-blind test based on ambulatory blood pressure monitoring, and 135 patients with a mean waking blood pressure of 155/100 mmHg were assigned randomly to receive either quinapril or placebo once a day for 8 weeks, with optional titration to a higher dose after 4 weeks, based on the DBP response assessed by repeat ambulatory blood pressure monitoring only.

RESULTS

Quinapril therapy produced highly significant decrease in mean daytime DBP compared with placebo. The antihypertensive effect of quinapril was evident over 24 h, with 50% of the peak effect remaining at the trough. After 4 weeks of treatment 49% of the patients in the quinapril group were titrated to the higher dose compared with 86% of the patients who had been receiving placebo. More than 70% of the patients in the quinapril group who remained at the low dose would have been titrated to the higher dose based solely on the clinic DBP measurements.

CONCLUSIONS

The use of ambulatory blood pressure monitoring in the present study reduced the false-positive response to placebo and lessened the likelihood of titrating patients to the higher dose of quinapril in comparison with the number that would have been so treated based on clinic blood pressure measurements alone. More importantly, our results suggest that the convenience, ease and relatively low cost of traditional cuff blood pressure measurement should be weighed against the potential shortcomings of the method.

摘要

目的

通过动态血压监测评估血管紧张素转换酶抑制剂盐酸喹那普利的疗效及作用持续时间。

设计

美国和加拿大的11个中心让155例先前诊断为高血压的患者进入为期4周的安慰剂基线期。20例仅通过袖带测量舒张压(DBP)升高的患者(13%)基于动态血压监测被排除进入双盲试验,135例平均清醒血压为155/100 mmHg的患者被随机分配,每天接受一次喹那普利或安慰剂治疗,为期8周,4周后可根据仅通过重复动态血压监测评估的DBP反应选择滴定至更高剂量。

结果

与安慰剂相比,喹那普利治疗使日间平均DBP显著降低。喹那普利的降压作用在24小时内均很明显,峰值效应的50%在谷值时仍存在。治疗4周后,喹那普利组49%的患者滴定至更高剂量,而接受安慰剂治疗的患者为86%。仅根据临床DBP测量,喹那普利组中超过70%维持低剂量的患者本会被滴定至更高剂量。

结论

与仅基于临床血压测量进行治疗的患者数量相比,本研究中使用动态血压监测减少了对安慰剂的假阳性反应,并降低了将患者滴定至更高剂量喹那普利的可能性。更重要的是,我们的结果表明,应权衡传统袖带血压测量的便利性、简易性和相对低成本与该方法的潜在缺点。

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Ambulatory blood pressure monitoring can play an integral role in patient selection, dosage adjustment and efficacy assessment in clinical trials of antihypertensive agents.动态血压监测在抗高血压药物临床试验的患者选择、剂量调整和疗效评估中可发挥不可或缺的作用。
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Pharmacologic treatment of chronic pediatric hypertension.儿童慢性高血压的药物治疗
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