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前蛋白转化酶枯草溶菌素9(PCSK9)抑制剂对急性冠状动脉综合征患者的疗效和安全性:一项随机对照试验的系统评价和荟萃分析

Efficacy and Safety of PSCK9 Inhibitors on Patients with Acute Coronary Syndrome: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

作者信息

Zhao Jiajing, Tong Xinyu, Peng Jian, Lyu Chuxin, Lu Shu

机构信息

Graduate School, Nanjing University of Chinese Medicine, 210029 Nanjing, Jiangsu, China.

Department of Cardiovascular, Wuxi Traditional Chinese Medicine Hospital, 214071 Wuxi, Jiangsu, China.

出版信息

Rev Cardiovasc Med. 2024 Mar 7;25(3):94. doi: 10.31083/j.rcm2503094. eCollection 2024 Mar.

Abstract

BACKGROUND

PCSK9 MaB (Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor) may reduce the occurrence of major adverse cardiovascular events (MACEs) in patients diagnosed with acute coronary syndrome (ACS). In this meta-analysis, we conducted a thorough compilation of evidence from established clinical studies to evaluate PCSK9 MaB's capacity to control blood lipid levels and prevent MACEs in ACS patients.

METHODS

We conducted searches on Pubmed, Embase, the Cochrane Library, and Web of Science to identify relevant articles. Data from ACS patients were extracted using a standardized format for aggregating data. We calculated the risk ratio (RR) for MACE and assessed changes in blood lipid parameters. All statistical analyses were performed using RevMan.

RESULTS

11 articles representing 5 trials were included in our systematic review and meta-analysis. When compared to a placebo, PCSK9 MaB significantly reduced the risk of MACEs ( = 0%, = 0.63, RR [95% CI] = 0.88 [0.81, 0.97], 0.01) and the recurrence rate of ACS ( = 45%, = 0.18, RR [95% CI] = 0.89 [0.83, 0.95], 0.01). Additionally, PCSK9 MaB notably reduced low-density lipoprotein cholesterol (LDL-C) levels (SMD [95% CI] = -2.12 [-2.32, -1.92], 0.01) and Apolipoprotein B (ApoB) levels (SMD [95% CI] = -1.83 [-2.48, -1.18], 0.01). Importantly, there were no significant differences in adverse reactions between the PCSK9 MaB group and the control group.

CONCLUSIONS

PCSK9 MaB, whether used as a standalone treatment or in combination with other therapies, can effectively inhibit PCSK9. It substantially lowers key blood lipid parameters, including low-density lipoprotein (LDL), ApoB, and triglycerides, all without giving rise to notable safety concerns.

摘要

背景

前蛋白转化酶枯草溶菌素9单克隆抗体(PCSK9 MaB)可能会降低急性冠状动脉综合征(ACS)患者发生主要不良心血管事件(MACE)的风险。在这项荟萃分析中,我们全面收集了已开展的临床研究证据,以评估PCSK9 MaB控制ACS患者血脂水平和预防MACE的能力。

方法

我们在PubMed、Embase、Cochrane图书馆和科学网进行检索,以识别相关文章。使用标准化格式提取ACS患者的数据以汇总数据。我们计算了MACE的风险比(RR),并评估了血脂参数的变化。所有统计分析均使用RevMan进行。

结果

我们的系统评价和荟萃分析纳入了代表5项试验的11篇文章。与安慰剂相比,PCSK9 MaB显著降低了MACE的风险(I² = 0%,τ² = 0.63,RR [95% CI] = 0.88 [0.81, 0.97],P < 0.01)和ACS的复发率(I² = 45%,τ² = 0.18,RR [95% CI] = 0.89 [0.83, 0.95],P < 0.01)。此外,PCSK9 MaB显著降低了低密度脂蛋白胆固醇(LDL-C)水平(SMD [95% CI] = -2.12 [-2.32, -1.92],P < 0.01)和载脂蛋白B(ApoB)水平(SMD [95% CI] = -1.83 [-2.48, -1.18],P < 0.01)。重要的是,PCSK9 MaB组和对照组之间的不良反应没有显著差异。

结论

PCSK9 MaB无论是单独使用还是与其他疗法联合使用,都能有效抑制PCSK9。它能大幅降低关键血脂参数,包括低密度脂蛋白(LDL)、ApoB和甘油三酯,且均未引发明显的安全问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0bf/11263862/2ce2f570e402/2153-8174-25-3-094-g1.jpg

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