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阿利沙坦酯片治疗高血压患者的疗效与安全性评价:一项荟萃分析

Efficacy and safety evaluation of Allisartan Isoproxil in patients with hypertension: a meta-analysis.

作者信息

Zhao Fengfeng, Liu Yihua, Chen Liang

机构信息

School of Clinical Medicine, Shandong Second Medical University, Weifang, Shandong, China.

Department of Adult Internal Medicine, Qingdao Women's and Children's Hospital, Qingdao, Shandong, China.

出版信息

Front Cardiovasc Med. 2024 Jun 6;11:1355014. doi: 10.3389/fcvm.2024.1355014. eCollection 2024.

Abstract

OBJECTIVE

This study aimed to evaluate the effectiveness and safety of Allisartan Isoproxil in the management of hypertension.

METHODS

A comprehensive search was conducted across both English and Chinese databases, including the Cochrane Library, Embase, PubMed, Web of Science, Chinese Journal Full Text Database (CNKI), Wanfang Digital Periodical Full Text Database, and VIP Chinese Periodical Database (VIP), up to March 24, 2024. Randomized controlled trials (RCTs) investigating alisartan axetil for hypertension management were selected. Literature quality was assessed, and data were extracted for meta-analysis using Stata 15.1 software. The quality of evidence for outcome indicators was evaluated using the GRADE system level.

RESULTS

Six RCTs involving 767 participants were included. Meta-analysis revealed that, compared to placebo, the Allisartan Isoproxil group exhibited a significant reduction in systolic blood pressure (SBP) [WMD = -8.08, 95% CI (-11.81, 4.10), = 0.000] and brachial-ankle pulse wave velocity (baPWV) [SMD = -0.69, 95% CI (-1.17, 0.20),  = 0.006]. However, the reduction in diastolic blood pressure (DBP) was not statistically significant [WMD = -5.48, 95% CI (-11.07, 0.10),  = 0.054]. Additionally, compared to calcium channel blockers (CCB) and angiotensin II receptor blockers (ARB), Allisartan Isoproxil did not significantly affect SBP [WMD = 0.20, 95% CI (-3.71, 4.10),  = 0.921] or DBP [WMD = 0.16, 95% CI (-2.11, 2.43),  = 0.891]. Allisartan Isoproxil demonstrated superior effects in increasing nitric oxide (NO) levels and decreasing endothelin (ET) levels compared to control groups [WMD = 9.56, 95% CI (6.42, 12.71), = 0.000], [WMD = -7.42, 95% CI (-11.13, -3.71),  = 0.000], and showed a higher effective control rate of blood pressure [RR = 1.26, 95% CI (1.13, 1.41),  = 0.000]. Subgroup analysis did not reveal significant differences. Regarding safety, there were no statistically significant differences in adverse events between the Allisartan Isoproxil group and the control groups [RR = 0.99, 95% CI (0.74, 1.32),  = 0.928], and no fatal adverse events were reported.

CONCLUSION

Allisartan Isoproxil is effective in reducing SBP and baPWV, increasing NO, decreasing ET, and achieving a higher control rate of blood pressure in patients with essential hypertension. These benefits are achieved with minimal adverse reactions.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023467869, identifier PROSPERO CRD42023467869.

摘要

目的

本研究旨在评估阿利沙坦酯片治疗高血压的有效性和安全性。

方法

检索了英文和中文数据库,包括考克兰图书馆、Embase、PubMed、Web of Science、中国期刊全文数据库(CNKI)、万方数据期刊全文数据库和维普中文期刊数据库(VIP),检索截止至2024年3月24日。选取了研究阿利沙坦酯片治疗高血压的随机对照试验(RCT)。评估文献质量,并使用Stata 15.1软件提取数据进行荟萃分析。使用GRADE系统水平评估结局指标的证据质量。

结果

纳入了6项涉及767名参与者的RCT。荟萃分析显示,与安慰剂相比,阿利沙坦酯片组的收缩压(SBP)显著降低[加权均数差(WMD)=-8.08,95%置信区间(CI)(-11.81,-4.10),P=0.000],臂踝脉搏波速度(baPWV)也显著降低[标准化均数差(SMD)=-0.69,95%CI(-1.17,-0.20),P=0.006]。然而,舒张压(DBP)的降低无统计学意义[WMD=-5.48,95%CI(-11.07,0.10),P=0.054]。此外,与钙通道阻滞剂(CCB)和血管紧张素II受体阻滞剂(ARB)相比,阿利沙坦酯片对SBP[WMD=0.20,95%CI(-3.71,4.10),P=0.921]或DBP[WMD=0.16,95%CI(-2.11,2.43),P=0.891]无显著影响。与对照组相比,阿利沙坦酯片在增加一氧化氮(NO)水平和降低内皮素(ET)水平方面显示出更好的效果[WMD=9.56,95%CI(6.42,1),P=0.000],[WMD=-7.42,95%CI(-11.13,-3.71),P=0.00],且血压有效控制率更高[相对危险度(RR)=1.26,95%CI(1.13,1.41),P=0.000]。亚组分析未发现显著差异。在安全性方面,阿利沙坦酯片组与对照组之间的不良事件无统计学显著差异[RR=0.99,95%CI(0.74,1.32),P=0.928],且未报告致命不良事件。

结论

阿利沙坦酯片可有效降低原发性高血压患者的SBP和baPWV,增加NO,降低ET,并实现更高的血压控制率。这些益处是在不良反应最小的情况下实现的。

系统评价注册

https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023467869,标识符PROSPERO CRD42023467869。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbcd/11187348/070476e8cc03/fcvm-11-1355014-g001.jpg

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