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黑种草籽提取物对老年人高血压的影响:一项双盲随机对照试验。

Effect of Nigella sativa Seed Extract for Hypertension in Elderly: a Double-blind, Randomized Controlled Trial.

作者信息

Rizka Aulia, Setiati Siti, Lydia Aida, Dewiasty Esthika

机构信息

Department of Internal Medicine, Faculty of Medicine Universitas Indonesia - Cipto Mangunkusumo Hospital, Jakarta, Indonesia..

出版信息

Acta Med Indones. 2017 Oct;49(4):307-313.

PMID:29348380
Abstract

BACKGROUND

Nigella sativa (NS) seed extract shows diuretic activity, inhibits sympathetic nervous system overactivity and increases the production of Nitric Oxide in in vivo studies, thus it has a potential use as an adjuvant antihypertensive for elderly population. This study aimed to determine the effect of Nigella sativa seed extract to systolic blood pressure (SBP) and diastolic blood pressure (DBP) of elderly patients with hypertension.

METHODS

a double-blind, randomized controlled trial was conducted on elderly subjects with hypertension in three outpatient clinics in Cipto Mangunkusumo National Hospital Jakarta Indonesia from June to September 2011. Subjects were divided into intervention group given 300 mg Nigella sativa seed extract twice daily for 28 days and into another group which was given placebo. Blood pressure were measured on day 1 and 28. Intention to treat analysis using unpaired t-test to compare blood pressure after intervention between the two groups was performed.

RESULTS

of a total of 85 patients, 76 subjects fulfilled the study criteria and were randomized into 2 groups, with 38 subjects in each group. Both groups were comparable in all important prognostic factors. The mean systolic blood pressure of the NS group was decreased from 160.4 (SD 15.7) mmHg to 145.8 (SD 19.8) mmHg, and from 160.9 (16.3) mmHg to 147.53 (SD 22.0) mmHg in the placebo group (p=0.36). The mean diastolic blood pressure in the NS group was decreased from 78.3 (SD 11.9) to 74.4 (SD 8.2) mmHg, and from 79.0 (SD 12.4) to 78.2 (SD 8.9) in the placebo group (p=0.35). Reported adverse events include dyspepsia in 6 subjects (15.7%), nausea in 3 subjects (7.8%), and constipation in 2 subjects (5.2%). No electrolyte abnormalities, liver and renal toxicities, or orthostatic hypotension were observed.

CONCLUSION

although a trend towards a slight decrease in blood pressure was observed, Nigella sativa has not been proven to be effective in reducing blood pressure in elderly patients with hypertension.

摘要

背景

在体内研究中,黑种草籽提取物显示出利尿活性,可抑制交感神经系统过度活跃并增加一氧化氮的生成,因此它有可能作为老年人群的辅助降压药。本研究旨在确定黑种草籽提取物对老年高血压患者收缩压(SBP)和舒张压(DBP)的影响。

方法

2011年6月至9月,在印度尼西亚雅加达的Cipto Mangunkusumo国立医院的三家门诊诊所,对老年高血压患者进行了一项双盲、随机对照试验。受试者被分为干预组,每天两次服用300毫克黑种草籽提取物,共28天,另一组服用安慰剂。在第1天和第28天测量血压。采用不成对t检验进行意向性分析,以比较两组干预后的血压。

结果

总共85名患者中,76名受试者符合研究标准并被随机分为两组,每组38名受试者。两组在所有重要的预后因素方面具有可比性。黑种草籽组的平均收缩压从160.4(标准差15.7)mmHg降至145.8(标准差19.8)mmHg,安慰剂组从160.9(16.3)mmHg降至147.53(标准差22.0)mmHg(p = 0.36)。黑种草籽组的平均舒张压从78.3(标准差11.9)降至74.4(标准差8.2)mmHg,安慰剂组从79.0(标准差12.4)降至78.2(标准差8.9)(p = 0.35)。报告的不良事件包括6名受试者(15.7%)出现消化不良,3名受试者(7.8%)出现恶心,2名受试者(5.2%)出现便秘。未观察到电解质异常、肝肾功能毒性或体位性低血压。

结论

尽管观察到血压有轻微下降的趋势,但黑种草籽尚未被证明对老年高血压患者降低血压有效。

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