双倍剂量氯吡格雷对冠心病支架植入术后氯吡格雷低反应患者的疗效及安全性研究

Efficacy and safety of double-dose clopidogrel treatment in patients with clopidogrel low response after percutaneous coronary intervention

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.