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克仑硫卓治疗原发性高血压患者的疗效与安全性:一项早期预试验结果

Efficacy and safety of clentiazem in patients with essential hypertension: results of an early pilot test.

作者信息

Kawakita S, Kinoshita M, Ishikawa H, Kagoshima T, Katori R, Ishikawa K, Hirota Y

机构信息

First Division of Internal Medicine, Shiga University of Medical Sciences, Japan.

出版信息

Clin Cardiol. 1991 Jan;14(1):53-60. doi: 10.1002/clc.4960140112.

DOI:10.1002/clc.4960140112
PMID:2019030
Abstract

The purpose of this study was to evaluate the antihypertensive effect of a new calcium antagonist, clentiazem, on inpatients or outpatients with essential hypertension. After blood pressure was stable and greater than 160/95 mmHg with placebo for at least a 2-week observation period, oral clentiazem was administered once daily and dosage was increased stepwise from 10 to 40 mg over 10 weeks. Blood pressure significantly decreased by the second week of the study, and this hypotensive effect was maintained until the eighth week. Cumulative effective rate (percent of patients whose blood pressure decreased in 20/10 mmHg) in 62 outpatients were as follows; 10.3% at 10 mg, 39.6% at 20 mg, 70.2% at 30 mg, 76.6% at 40 mg. There was no significant postural change observed in the blood pressure from supine to standing position. Side effects such as dizziness, general malaise and gait disturbances were observed in 3 (3.9%) of 76 patients. No abnormal changes in clinical laboratory examinations or electrocardiograms were caused by clentiazem. Thus these data demonstrated that clentiazem produces certain antihypertensive effects with sufficient safety.

摘要

本研究旨在评估新型钙拮抗剂氯噻嗪对原发性高血压住院患者或门诊患者的降压效果。在至少为期2周的观察期内,使用安慰剂使血压稳定且高于160/95 mmHg后,每日口服一次氯噻嗪,并在10周内将剂量从10 mg逐步增加至40 mg。在研究的第二周血压显著下降,且这种降压效果一直维持到第八周。62例门诊患者的累积有效率(血压下降20/10 mmHg的患者百分比)如下:10 mg时为10.3%,20 mg时为39.6%,30 mg时为70.2%,40 mg时为76.6%。从仰卧位到站立位,血压未观察到明显的体位变化。76例患者中有3例(3.9%)出现头晕、全身不适和步态障碍等副作用。氯噻嗪未引起临床实验室检查或心电图的异常变化。因此,这些数据表明氯噻嗪具有一定的降压效果且安全性良好。

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