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低剂量螺内酯单药治疗I期原发性高血压:一项前瞻性随机双盲安慰剂对照试验

Low Dose Spironolactone Monotherapy in the Management of Stage I Essential Hypertension: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial.

作者信息

Attar Armin, Sadeghi Amir-Abbas, Amirmoezi Fatemeh, Aghasadeghi Kamran

机构信息

Cardiovascular Research Center, TAHA Clinical Trial Group.

Student Research Committee.

出版信息

Acta Cardiol Sin. 2018 Jan;34(1):59-65. doi: 10.6515/ACS.201801_34(1).20170903B.

Abstract

BACKGROUND

High blood pressure (BP) is a common chronic disease needs long life drug consumption to control. Spironolactone could be used as the fourth-line therapy in patients with resistant hypertension. However, there is no study to determine the effects of low dose spironolactone as a first line therapy in treatment of essential hypertension. The aim of this study is to investigate the effect of low dose spironolactone monotherapy in management of essential hypertension.

METHODS

In this double blind randomized clinical trial, 40 patients who had stage I essential hypertension were randomly divided into two groups: intervention group received spironolactone 25 milligram once daily for one month and control group received placebo once daily. At the baseline and after one month, 24-hour BP holter-monitoring and serum potassium assay were done.

RESULTS

Systolic BP was reduced from 143.5 ± 8.2 mmHg to 137.10 ± 7.57 mmHg in the intervention group, while it did not change significantly in control (between group treatment difference = -4.5 mmHg, p = 0.004). There was no significant reduction of diastolic BP in the intervention group in comparison to placebo group (between group treatment difference = -1.3 mmHg, p = 0.099).

CONCLUSIONS

Short course monotherapy with low dose spironolactone is effective in reducing systolic BP in patients with stage I essential hypertension.

摘要

背景

高血压是一种常见的慢性病,需要长期服用药物来控制。螺内酯可作为顽固性高血压患者的四线治疗药物。然而,尚无研究确定低剂量螺内酯作为一线治疗原发性高血压的效果。本研究的目的是探讨低剂量螺内酯单药治疗原发性高血压的效果。

方法

在这项双盲随机临床试验中,40例I期原发性高血压患者被随机分为两组:干预组每日服用一次25毫克螺内酯,持续一个月,对照组每日服用一次安慰剂。在基线期和一个月后,进行24小时血压动态监测和血钾测定。

结果

干预组收缩压从143.5±8.2 mmHg降至137.10±7.57 mmHg,而对照组无显著变化(组间治疗差异=-4.5 mmHg,p=0.004)。与安慰剂组相比,干预组舒张压无显著降低(组间治疗差异=-1.3 mmHg,p=0.099)。

结论

低剂量螺内酯短期单药治疗对I期原发性高血压患者降低收缩压有效。

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