不同维持剂量氯吡格雷对患者经皮冠脉介入术后疗效和安全性的系统评价

Efficacy and safety of different maintenance doses of clopidogrel for patients after percutaneous coronary intervention：a systematic review

摘要:

目的：系统性评价不同维持剂量氯吡格雷对经皮冠脉介入（percutaneous coronary intervention，PCI）术后患者的疗效和安全性，为临床决策提供依据。方法：采用循证医学的文献分析评价方案，全面收集不同维持剂量氯吡格雷应用于PCI术后患者的随机对照试验（randomized controlled trials，RCTs）。提取有效数据，评价纳入研究的方法学质量，采用Rev Man 5.0软件对数据进行Meta分析。结果：共纳入13项RCTs，共2 883例患者。Meta分析结果显示：与75 mg常规维持剂量氯吡格雷相比，150 mg的高维持剂量明显降低患者血小板聚集率（MD=-12.20，95%CI=-13.77~-10.63，P=0.000），同时明显降低主要不良心脏事件（major adverse cardiac events，MACE）发生率（RR=0.41，95%CI=0.27~0.63，P=0.000）。而且，高维持剂量组不增加患者主要出血风险（RR=1.61，95%CI=0.90~2.87，P=0.110）和次要出血风险（RR=1.19，95%CI=0.87~1.62，P=0.270）。结论：与75 mg常规维持剂量氯吡格雷相比，PCI术后患者应用150 mg氯吡格雷具有更好疗效且不增加出血风险。

Abstract:

Objective：To assess the efficacy and safety of different maintenance doses of clopidogrel for patients after percutaneous coronary intervention（PCI） by a meta-analysis and to provide some advices for clinical therapy. Methods：According to the methods of evidence-based medicine，randomized controlled trials（RCTs） about the different maintenance doses of clopidogrel using on pa－tients after PCI were searched. Data were extracted into a designed form and the quality of selected articles was analyzed. The Rev Man 5.0 software was used for data analysis. Results：Thirteen RCTs containing 2 883 patients were included. The meta-analysis showed that 150 mg clopidogrel significantly inhibited platelet aggregation（PA） and reduced major adverse cardiac events（MACE） incidence than 75 mg clopidogrel（MD=-12.20，95%CI=-13.77 to -10.63，P=0.000）（RR=0.41，95%CI=0.27 to 0.63，P=0.000）. Finally，No obvious difference was found in major bleeding（RR=1.61，95%CI=0.90 to 2.87，P=0.110） or minor bleeding（RR=1.19，95%CI=0.87 to 1.62，P=0.270） between the two groups. Conclusion：Clopidogrel with dose of 150 mg is superior to clopidogrel with dose of 75 mg in inhibiting PA and reducing MACE for patients after PCI without bleeding risk.