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经皮冠状动脉介入治疗患者中低剂量普拉格雷与氯吡格雷的临床疗效和安全性:一项随机对照试验的系统评价和荟萃分析

Clinical Efficacy and Safety of Reduced-Dose Prasugrel versus Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

作者信息

Peng Chia-Hua, Huang Tsung-Pin, Chen Yu-Hung, Hsu Chia-Huei, Cheng I-Ling

机构信息

Department of Pharmacy.

Department of Internal Medicine, Chi Mei Medical Center, Tainan, Taiwan.

出版信息

Acta Cardiol Sin. 2022 Jul;38(4):425-434. doi: 10.6515/ACS.202207_38(4).20220319A.

DOI:10.6515/ACS.202207_38(4).20220319A
PMID:35873133
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9295039/
Abstract

OBJECTIVES

This systematic review and meta-analysis of randomized controlled trials (RCTs) compared the clinical efficacy and safety of reduced-dose prasugrel (loading dose: 20 mg; daily maintenance dose: 3.75 mg) and clopidogrel in patients undergoing percutaneous coronary intervention (PCI).

METHODS

PubMed, Embase, and the Cochrane Library database were searched for relevant articles from inception to March 8, 2021. Only RCTs that compared the clinical efficacy and safety of reduced-dose prasugrel and clopidogrel treatment in adult patients undergoing PCI were included. The primary outcome was the risk of major cardiovascular events (MACEs).

RESULTS

Four RCTs involving 2464 patients were included. The overall risk of MACEs was 8.3% (102/1235) in the study group (reduced-dose prasugrel) and 9.8% (121/1229) in the control group (clopidogrel). No significant difference was observed in the risk of MACEs between the study and control groups (risk ratio: 0.84, 95% confidence interval: 0.65-1.08, = 0%). In addition, cardiovascular-related death, all-cause death, nonfatal myocardial infarction, nonfatal stroke, revascularization, and stent thrombosis did not differ significantly between the two groups. Apart from a higher risk of minor bleeding in the study group, reduced-dose prasugrel had a similar bleeding risk to clopidogrel.

CONCLUSIONS

The clinical efficacy of reduced-dose prasugrel is comparable to that of clopidogrel; however, the risk of minor bleeding should be considered when prescribing this regimen for patients undergoing PCI.

摘要

目的

本项对随机对照试验(RCT)的系统评价和荟萃分析比较了低剂量普拉格雷(负荷剂量:20 mg;每日维持剂量:3.75 mg)与氯吡格雷在接受经皮冠状动脉介入治疗(PCI)患者中的临床疗效和安全性。

方法

检索了PubMed、Embase和Cochrane图书馆数据库,以查找从数据库建立至2021年3月8日的相关文章。仅纳入比较低剂量普拉格雷与氯吡格雷治疗在接受PCI的成年患者中的临床疗效和安全性的RCT。主要结局是主要心血管事件(MACE)风险。

结果

纳入了4项涉及2464例患者的RCT。研究组(低剂量普拉格雷)的MACE总体风险为8.3%(102/1235),对照组(氯吡格雷)为9.8%(121/1229)。研究组和对照组之间的MACE风险未观察到显著差异(风险比:0.84,95%置信区间:0.65 - 1.08,P = 0%)。此外,两组在心血管相关死亡、全因死亡、非致命性心肌梗死、非致命性卒中、血运重建和支架血栓形成方面无显著差异。除研究组轻微出血风险较高外,低剂量普拉格雷的出血风险与氯吡格雷相似。

结论

低剂量普拉格雷的临床疗效与氯吡格雷相当;然而,在为接受PCI的患者开具此治疗方案时应考虑轻微出血风险。

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本文引用的文献

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Comparison of Clinical Outcomes of Acute Myocardial Infarction Between Prasugrel and Clopidogrel.比较普拉格雷与氯吡格雷治疗急性心肌梗死的临床结局。
Int Heart J. 2021 May 29;62(3):479-486. doi: 10.1536/ihj.20-357. Epub 2021 May 15.
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Oral Antiplatelet Therapy After Acute Coronary Syndrome: A Review.急性冠状动脉综合征后的口服抗血小板治疗:综述。
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Reduced-Dose Prasugrel versus Clopidogrel for Patients Undergoing Percutaneous Coronary Intervention.接受经皮冠状动脉介入治疗的患者中,使用低剂量普拉格雷与氯吡格雷的效果比较。
Int Heart J. 2021 Mar 30;62(2):246-255. doi: 10.1536/ihj.20-508. Epub 2021 Mar 17.
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Randomized Comparison of Intensified and Standard P2Y-Receptor-Inhibition Before Elective Percutaneous Coronary Intervention: The SASSICAIA Trial.随机比较强化和标准 P2Y12 受体抑制在选择性经皮冠状动脉介入治疗前的效果:SASSICAIA 试验。
Circ Cardiovasc Interv. 2020 Jun;13(6):e008649. doi: 10.1161/CIRCINTERVENTIONS.119.008649. Epub 2020 Jun 12.
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Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial.氯吡格雷与替格瑞洛或普拉格雷在 70 岁或以上非 ST 段抬高型急性冠脉综合征患者中的比较(POPular AGE):随机、开放标签、非劣效性试验。
Lancet. 2020 Apr 25;395(10233):1374-1381. doi: 10.1016/S0140-6736(20)30325-1.
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Impact of reduced-dose prasugrel vs. standard-dose clopidogrel on in-hospital outcomes of percutaneous coronary intervention in 62 737 patients with acute coronary syndromes: a nationwide registry study in Japan.在 62737 例急性冠脉综合征患者中,与标准剂量氯吡格雷相比,使用低剂量普拉格雷对经皮冠状动脉介入治疗住院结局的影响:一项日本全国注册研究。
Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1;6(4):231-238. doi: 10.1093/ehjcvp/pvz056.
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Real-world comparison of clopidogrel, prasugrel and ticagrelor in patients undergoing primary percutaneous coronary intervention.真实世界中经皮冠状动脉介入治疗患者中氯吡格雷、普拉格雷和替格瑞洛的比较。
Open Heart. 2019 Jun 29;6(1):e000951. doi: 10.1136/openhrt-2018-000951. eCollection 2019.
8
Impact of low-dose prasugrel on platelet reactivity and cardiac dysfunction in acute coronary syndrome patients requiring primary drug-eluting stent implantation: A randomized comparative study.低剂量普拉格雷对需要植入第一代药物洗脱支架的急性冠脉综合征患者血小板反应性及心脏功能障碍的影响:一项随机对照研究。
Catheter Cardiovasc Interv. 2020 Jan;95(1):E8-E16. doi: 10.1002/ccd.28277. Epub 2019 Apr 14.
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Impact of dual antiplatelet therapy with adjusted-dose prasugrel on mid-term vascular response in patients undergoing elective percutaneous coronary intervention with everolimus-eluting stents.调整剂量普拉格雷双重抗血小板治疗对接受依维莫司洗脱支架选择性经皮冠状动脉介入治疗患者中期血管反应的影响。
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Comparison of Reduced-Dose Prasugrel and Standard-Dose Clopidogrel in Elderly Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Revascularization.老年急性冠状动脉综合征患者行早期经皮血运重建术时,使用普拉格雷低剂量与氯吡格雷标准剂量的比较。
Circulation. 2018 Jun 5;137(23):2435-2445. doi: 10.1161/CIRCULATIONAHA.117.032180. Epub 2018 Feb 19.