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奥美沙坦异丙酯可改善原发性高血压患者的血管内皮功能和血管损伤:一项单中心、开放性、随机对照试验。

Allisartan Isoproxil Improves Endothelial Function and Vascular Damage in Patients with Essential Hypertension: A Single-Center, Open-Label, Randomized Controlled Trial.

机构信息

Department of Cardiology, The Jiangmen Central Hospital, Jiangmen, China.

Department of Hypertension and Vascular Disease, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.

出版信息

Adv Ther. 2020 Aug;37(8):3551-3561. doi: 10.1007/s12325-020-01413-y. Epub 2020 Jun 24.

Abstract

INTRODUCTION

Allisartan isoproxil is a novel angiotensin II type 1 receptor antagonist that has been confirmed to lower blood pressure and protect target organs effectively. However, its role in improving endothelial function and vascular damage has not been investigated yet.

METHODS

Patients with initially diagnosed mild essential hypertension (BP ranging from 140/90 to 159/99 mmHg) with age from 25-75 years were randomly assigned 1:1 to either the allisartan group (allisartan 240 mg/day and lifestyle modification) or the lifestyle modification group and were followed up for 30 days. Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage. In addition, we enrolled 36 normotensive individuals as healthy control.

RESULTS

Seventy-two mildly hypertensive patients were enrolled in this study. After 30 days of treatment, a significant increase in FMD was observed in the allisartan group (0.9 ± 0.7%, p < 0.001) and remained unchanged in the lifestyle modification group, but the difference between the two groups did not reach statistical significance (p = ns). EMPs, baPWV, SBP and DBP decreased by 251.0 ± 255.9 counts/μl (p < 0.001), 102.8 ± 84.2 cm/s (p < 0.001), 13.20 ± 3.9 mmHg (p < 0.001) and 9.35 ± 2.5 mmHg (p < 0.001), respectively, in the allisartan group, while by 21.3 ± 84.3 counts/μl (p = ns), 0.4 ± 22.0 cm/s (p = ns), 3.2 ± 6.0 mmHg (p < 0.01) and 1.0 ± 2.5 mmHg (p = ns), respectively, in the lifestyle modification group. All of the indexes above achieved statistical significance between the allisartan and lifestyle modification groups (p < 0.05). Besides, after 30 days of allisartan administration baPWV and EMPs were comparable to those measured in the healthy control group, while the difference in SBP, DBP and FMD remained significant between the allisartan and healthy control groups (p < 0.05).

CONCLUSION

The present study demonstrates for the first time that allisartan isoproxil exerts a favorable effect on improving endothelial function and vascular damage in patients with mild EH, making it a promising drug for management of EH.

CLINICAL TRIAL REGISTRATION

ChiCTR2000032332.

摘要

简介

奥美沙坦异丙酯是一种新型的血管紧张素 II 型 1 型受体拮抗剂,已被证实能有效降低血压并保护靶器官。然而,它在改善内皮功能和血管损伤方面的作用尚未得到研究。

方法

将年龄在 25-75 岁之间、初诊为轻度原发性高血压(血压在 140/90 至 159/99mmHg 之间)的患者随机分为奥美沙坦组(奥美沙坦 240mg/天和生活方式改变)和生活方式改变组,随访 30 天。通过测量血流介导的扩张(FMD)、肱踝脉搏波速度(baPWV)和内皮微粒(EMPs)来评估内皮功能和血管损伤。此外,我们还招募了 36 名血压正常的个体作为健康对照组。

结果

本研究共纳入 72 名轻度高血压患者。经过 30 天的治疗,奥美沙坦组的 FMD 显著增加(0.9±0.7%,p<0.001),而生活方式改变组无变化,但两组间差异无统计学意义(p=ns)。奥美沙坦组的 EMPs、baPWV、SBP 和 DBP 分别降低了 251.0±255.9 个/μl(p<0.001)、102.8±84.2cm/s(p<0.001)、13.20±3.9mmHg(p<0.001)和 9.35±2.5mmHg(p<0.001),而生活方式改变组分别降低了 21.3±84.3 个/μl(p=ns)、0.4±22.0cm/s(p=ns)、3.2±6.0mmHg(p<0.01)和 1.0±2.5mmHg(p=ns)。上述所有指标在奥美沙坦组和生活方式改变组之间均有统计学意义(p<0.05)。此外,奥美沙坦治疗 30 天后,baPWV 和 EMPs 与健康对照组相当,而 SBP、DBP 和 FMD 与健康对照组仍有显著差异(p<0.05)。

结论

本研究首次证明奥美沙坦异丙酯对改善轻度 EH 患者的内皮功能和血管损伤具有良好的效果,有望成为 EH 管理的一种药物。

临床试验注册

ChiCTR2000032332。

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