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基于复方药丸的策略与心血管疾病二级预防的常规治疗相比:随机对照试验的荟萃分析。

Polypill-based strategy vs. usual care for secondary prevention of cardiovascular disease: a meta-analysis of randomized controlled trials.

机构信息

Department of Medicine, Nove de Julho University, São Bernardo do Campo, Brazil.

Department of Medicine, Maurício de Nassau University, Cacoal, Brazil.

出版信息

Eur J Prev Cardiol. 2023 Nov 9;30(16):1828-1837. doi: 10.1093/eurjpc/zwad245.

Abstract

AIMS

We aimed to perform a systematic review and meta-analysis of randomized controlled trials (RCTs) to determine the impact of a polypill-based strategy (PBS) on therapeutic adherence and cardiovascular outcomes compared with usual care for secondary prevention of cardiovascular diseases (CVDs).

METHODS AND RESULTS

We systematically searched PubMed, Cochrane, and Scopus databases from inception to January 2023, including RCTs comparing PBS with usual care in patients with prior CVD. We assessed efficacy outcomes of therapeutic adherence, systolic blood pressure (SBP), and LDL-cholesterol (LDL-C) and safety outcomes of all-cause and cardiovascular mortality. Statistical analysis was performed with Review Manager 5.4.1 and R Version 4.2.1. A total of 8 RCTs with a population of 6541 individuals were included, of whom 3318 (50.7%) were treated with the PBS. Follow-up ranged from 6 to 60 months. The polypill-based strategy was associated with a significantly increased therapeutic adherence [risk ratio (RR) 1.22; 95% confidence interval (CI) 1.10-1.34; P < 0.001]. Cardiovascular mortality (RR 0.61; 95% CI 0.44-0.85; P = 0.004), SBP [mean difference (MD) -1.47 mmHg; 95% CI -2.86 to -0.09; P = 0.04], and LDL-C (MD -3.83 mg/dL; 95% CI -6.99 to -0.67; P = 0.02) were significantly lower in the PBS group. The incidence of all-cause mortality was similar between groups (RR 0.83; 95% CI 0.54-1.29; P = 0.41).

CONCLUSION

In patients with pre-existing CVD, a PBS is associated with lower cardiovascular mortality and improved therapeutic adherence, along with a modest decrease in SBP and LDL-C compared with usual care. Thus, a PBS may be considered a preferred option for this patient population.

摘要

目的

我们旨在进行系统评价和荟萃分析,以确定与常规护理相比,基于多效药丸(PBS)的策略对心血管疾病(CVD)二级预防的治疗依从性和心血管结局的影响。

方法和结果

我们系统地检索了 PubMed、Cochrane 和 Scopus 数据库,检索时间从建库至 2023 年 1 月,包括比较 PBS 与 CVD 既往患者常规护理的 RCT。我们评估了治疗依从性、收缩压(SBP)和 LDL-胆固醇(LDL-C)的疗效结局以及全因和心血管死亡率的安全性结局。使用 Review Manager 5.4.1 和 R 版本 4.2.1 进行统计分析。共纳入 8 项 RCT,共 6541 例患者,其中 3318 例(50.7%)接受 PBS 治疗。随访时间从 6 至 60 个月不等。基于多效药丸的策略与治疗依从性显著提高相关[风险比(RR)1.22;95%置信区间(CI)1.10-1.34;P < 0.001]。心血管死亡率(RR 0.61;95%CI 0.44-0.85;P = 0.004)、SBP[平均差值(MD)-1.47mmHg;95%CI-2.86 至-0.09;P = 0.04]和 LDL-C(MD-3.83mg/dL;95%CI-6.99 至-0.67;P = 0.02)在 PBS 组中显著降低。两组全因死亡率相似(RR 0.83;95%CI 0.54-1.29;P = 0.41)。

结论

在患有预先存在的 CVD 的患者中,与常规护理相比,基于多效药丸的策略与较低的心血管死亡率和改善的治疗依从性相关,同时 SBP 和 LDL-C 略有降低。因此,对于该患者群体,PBS 可能被视为首选方案。

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