目的:评估双倍剂量氯吡格雷强化抗栓1个月与常规剂量相比对冠心病经皮冠状动脉支架植入(percutaneous coronary intervention,PCI)术后氯吡格雷低反应性(clopidogrel low response,CLR)患者血小板聚集功能的影响及安全性。方法:将冠心病PCI术后通过光学血小板聚集仪检测发现的CLR患者92例随机分为常规剂量组与双倍剂量组,观察两组患者1个月后血小板聚集功能的变化并随访1年的临床预后及安全性。结果:在住院期间两组患者的二磷酸腺苷诱导的血小板聚集率(adenosine diphosphate induced platelet aggregation,PLADP)无显著差异(P〉0.05);但在1个月随访时双倍剂量组的PLADP显著低于常规剂量组(P〈0.001);1年随访主要不良事件在两组间的发生率均为4.3%。常规剂量组的次要不良事件发生率高于双倍剂量组,主要表现为心源性再入院率显著高于双倍剂量组(P〈0.01)。双倍剂量组大出血(0%vs.0%)、小出血(0%vs.0%)、轻微出血(10.9%vs.10.9%)的发生率与常规剂量组相当。结论:与常规剂量组相比,双倍剂量氯吡格雷强化抗栓1个月能显著降低氯吡格雷低反应患者的血小板聚集率,显著降低1年随访的心源性再入院率,且未增加出血风险。
Objective:To evaluate the efficacy and safety of double-dose clopidogrel compared with routine-dose dual anti-platelet treatment(DAPT)in patients with clopidogrel low response(CLR)after percutaneous coronary intervention(PCI). Methods:Ninety-two CLR patients were screened by light transmission aggregometry(LTA)after PCL and randomly divided into the clopidogrel routine-dose group and the clopidogrel double-dose group after taking routine-dose aspirin and clopidogrel for more than five days. Platelet aggregation was determined by LTA one-month post-randomization. The patients were followed up and all clinical events were recorded for one year. Results:There was no significant difference of adenosine diphosphate induced platelet aggregation(PLADP)between the two groups at baseline(P〈0.05). However,the PLADPlevel of the double-dose group was significantly lower than that of the routine-dose group at one-month follow-up(P〈0.001). The major adverse event rates of the two groups were both 4.3%. The double-dose group presented less secondary adverse events compared with the double-dose group,mainly attributed to cardiac rehospitalization(P〈0.01). The two groups showed comparable major bleed events(0% vs. 0%),as well as minor and minimal bleeding events(0% vs. 0% and 10.9% vs. 10.9%,respectively). Conclusion:Double-dose clopidogrel can significantly improve the ADP-induced platelet aggregation during the first month and may lower the cardiac rehospitalization event without excessive risk of bleeding in CLR patients undergoing PCI during one-year follow-up.