基于真实世界的替格瑞洛与氯吡格雷药物警戒研究

A Real-World Based Pharmacovigilance Study of Ticagrelor and Clopidogrel

摘要: 目的：对替格瑞洛与氯吡格雷的药物安全性展开比较。方法：检索中外数据库中研究替格瑞洛与氯吡格雷的随机对照试验，采用Meta分析法对两种药物引发的不良反应进行研究；基于美国FDA不良事件报告系统(FAERS)对替格瑞洛与氯吡格雷的不良事件风险信号进行挖掘和分析。结果：Meta分析共纳入12项RCT，37,156例患者，氯吡格雷20,236例，替格瑞洛16,920例，两组患者主要出血事件(RR = 1.27, 95%CI: 1.11~1.44, P < 0.05)以及呼吸困难(RR = 1.69, 95%CI: 1.56, 1.82, P < 0.05)；基于FAERS获得氯吡格雷组不良事件报告26,829份，替格瑞洛不良事件报告16,720份，氯吡格雷阳性信号430个，替格瑞洛阳性信号357个。结论：替格瑞洛在出血及呼吸系统不良事件方面呈现更高的风险特征，氯吡格雷显示出更广泛的不良事件阳性信号。

Abstract: Objective: A comparison of the drug safety of clopidogrel versus ticagrelor was initiated. Methods: Randomized controlled trials studying ticagrelor versus clopidogrel were retrieved, and meta-analysis was used to study the adverse reactions triggered by the two drugs; the risk signals of adverse events of ticagrelor versus clopidogrel were mined and analyzed based on the FDA Adverse Event Reporting System (FAERS). Results: Meta-analysis included 12 RCTs with 37,156 patients, 20,236 clopidogrel and 16,920 ticagrelor, with major bleeding events (RR = 1.27, 95%CI: 1.11~1.44, P < 0.05) and dyspnea (RR = 1.69, 95%CI: 1.56, 1.82, P < 0.05) in the two groups; based on the FAERS obtained 26,829 adverse event reports in the clopidogrel group and 16,720 adverse event reports in the ticagrelor group, with 430 positive signals for clopidogrel and 357 positive signals for ticagrelor. Conclusions: Ticagrelor presented a higher risk profile for bleeding and respiratory adverse events, and clopidogrel showed a broader positive signal for adverse events.