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低收入和中等收入国家中低剂量三联单片复方制剂与标准治疗方案治疗高血压的疗效和安全性:三项随机对照试验的系统评价和荟萃分析

Efficacy and Safety of Low-Dose Triple Single Pill Combination Versus Standard Care in the Management of Hypertension in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis of Three Randomized Controlled Trials.

作者信息

Adamu Umar G, Mojela Kabo, Adamu El-Ameen U, Ojji Dike, Tsabedze Nqoba

机构信息

Division of Cardiology, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg, South Africa.

College of Health Sciences, Usmanu DanFodiyo University, Sokoto, Nigeria.

出版信息

High Blood Press Cardiovasc Prev. 2025 Jun 9. doi: 10.1007/s40292-025-00720-1.

DOI:10.1007/s40292-025-00720-1
PMID:40488970
Abstract

INTRODUCTION

Low Low-dose triple single pill combination therapy is recommended for hypertension treatment. However, the efficacy and safety of these combinations in low- and middle-income countries (LMICs) remain unclear.

AIM

We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of low-dose triple single pill combination therapy in controlling blood pressure (BP) in LMICs.

METHODS

We systematically searched PubMed, Embase, Cochrane, and ClinicalTrials.gov for randomised controlled trials (RCTs) comparing low-dose triple single pill combination therapy with standard care for hypertension management up to 29 January 2025. Mean differences (MD) were computed for continuous outcomes and risk ratio (RR) with 95% confidence intervals (CI) for binary outcomes.

RESULTS

Three RCTs comprising 1758 patients, of whom 752 (43%) received low-dose triple single pill combination therapy, were included. The proportion of patients that achieved target BP at six weeks was higher with this therapy (RR 1.89; 95% CI 1.29, 2.75; P < 0.001). Compared with standard care, it significantly reduced SBP (MD - 5.30 mmHg; 95% CI - 9.55, - 0.92; P = 0.017), DBP (MD - 3.50 mmHg; 95% CI - 4.95, - 2.05; P < 0.001), and urine albumin-to-creatinine ratio (RR 0.59; 95% CI 0.44, 0.80; P < 0.001). No significant differences in adherence, withdrawal, or adverse effects were observed between groups.

CONCLUSION

In this meta-analysis, the use of a low-dose triple single pill combination in hypertensive patients in LMICs led to earlier and sustained blood pressure control and reduced urine albumin-to-creatinine ratio, with a safety profile comparable to standard care. PROSPERO registration: Number: CRD42025647884, Date: 15 February 2025.

摘要

引言

低剂量三联单片复方疗法被推荐用于高血压治疗。然而,这些联合疗法在低收入和中等收入国家(LMICs)的疗效和安全性仍不明确。

目的

我们进行了一项系统评价和荟萃分析,以评估低剂量三联单片复方疗法在LMICs中控制血压(BP)的疗效和安全性。

方法

我们系统检索了PubMed、Embase、Cochrane和ClinicalTrials.gov,以查找截至2025年1月29日比较低剂量三联单片复方疗法与高血压管理标准治疗的随机对照试验(RCTs)。计算连续结局的平均差(MD)和二分类结局的风险比(RR)及95%置信区间(CI)。

结果

纳入了3项RCTs,共1758例患者,其中752例(43%)接受低剂量三联单片复方疗法。该疗法在6周时达到目标血压的患者比例更高(RR 1.89;95% CI 1.29,2.75;P < 0.001)。与标准治疗相比,它显著降低了收缩压(MD -5.30 mmHg;95% CI -9.55,-0.92;P = 0.017)、舒张压(MD -3.50 mmHg;95% CI -4.95,-2.05;P < 0.001)和尿白蛋白肌酐比值(RR 0.59;95% CI 0.44,0.80;P < 0.001)。两组在依从性、退出率或不良反应方面未观察到显著差异。

结论

在这项荟萃分析中,在LMICs的高血压患者中使用低剂量三联单片复方疗法可实现更早且持续的血压控制,并降低尿白蛋白肌酐比值,其安全性与标准治疗相当。国际前瞻性系统评价注册库(PROSPERO)注册号:编号:CRD42025647884,日期:2025年2月15日。

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本文引用的文献

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Treatment Strategies to Control Blood Pressure in People With Hypertension in Tanzania and Lesotho: A Randomized Clinical Trial.坦桑尼亚和莱索托高血压患者血压控制的治疗策略:一项随机临床试验
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