利伐沙班片联合氯吡格雷片和/或阿司匹林肠溶片用于心房颤动患者经皮冠状动脉介入治疗术后的临床研究

Clinical trial of rivaroxaban tablets combined with clopidogrel tabets and/or aspirin enteric-coated tablets in the treatment of patients with atrial fibrillation after percutaneous coronary intervention

目的观察利伐沙班片联合氯吡格雷片和/或阿司匹林肠溶片用于心房颤动患者经皮冠状动脉介入治疗(PCI)术后的临床疗效及安全性。方法将168例拟进行PCI术的心房颤动患者随机分为A,B和C组,每组56例。PCI术后,A组予以利伐沙班每次10 mg,qd,口服+氯吡格雷每次75 mg,qd,口服+阿司匹林每次100 mg,qd,口服;B组予以利伐沙班每次10 mg,qd,口服+氯吡格雷每次75 mg,qd,口服;C组给予华法林钠每次3 mg,qd,口服+氯吡格雷每次75 mg,qd,口服+阿司匹林每次100 mg,qd,口服。3组患者均治疗12个月。比较3组患者的临床疗效、凝血功能和12个月累积主要不良心血管事件(MACE)发生率,以及药物不良反应的发生情况。结果治疗后,A和B组的总有效率分别为92. 86%(52例/56例)和89. 29%(50例/56例)均明显高于C组的73. 21%(41例/56例),差异均有统计学意义(均P <0. 05)。治疗后,A,B和C组的凝血酶原时间分别为(17. 16±2. 45),(16. 91±2. 29)和(15. 88±2. 14) s,活化部分凝血活酶时间分别为(38. 07±4. 63),(37. 89±4. 82)和(35. 76±4. 79) s,纤维蛋白原分别为(4. 23±1. 38),(4. 15±1. 47)和(3. 51±1. 25) g·L-1,12个月累积MACE发生率分别为8. 93%,14. 28%和28. 57%,A和B组的上述指标与C组比较,差异均有统计学意义(均P <0. 05)。3组患者的药物不良反应均以呕吐、头晕和皮疹为主。A,B和C组的总药物不良反应发生率分别为7. 14%,7. 14%和10. 71%,差异无统计学意义(均P> 0. 05)。结论利伐沙班片联合氯吡格雷片和(或)阿司匹林肠溶片用于心房颤动患者PCI术后的临床疗效确切,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of rivaroxaban tablets combined with clopidogrel tabets and/or aspirin enteric-coated tablets in the treatment of patients with atrial fibrillation after percutaneous coronary intervention(PCI).Methods A total of 168 patients with atrial fibrillation undergoing PCI were randomly divided into A,B and C groups with 56 cases per group.After PCI,A group was treated with rivaroxaban 10 mg per time,qd,orally+clopidogrel 75 mg per time,qd,orally+aspirin 100 mg per time,qd,orally;B group was given rivaroxaban 10 mg per time,qd,orally+clopidogrel 75 mg per time,qd,orally;C group received warfarin 3 mg per time,qd,orally+clopidogrel 75 mg per time,qd,orally+aspirin 100 mg per time,qd,orally.Three groups were treated for 12 months.The clinical efficacy,coagulation function,incidence of major adverse cardiovascular events(MACE)and adverse drug reactions were compared among the three groups.Results After treatment,the total effective rates of A and B groups were 92.86%(52 cases/56 cases)and 89.29%(50 cases/56 cases),which were higher than that of C group(73.21%,41 cases/56 cases),the differences were statistically significant(all P<0.05).After treatment,the main indexes of A,B and C groups were compared:prothrombin time were(17.16±2.45),(16.91±2.29)and(15.88±2.14)s,activated partial thromboplastin time were(38.07±4.63),(37.89±4.82)and(35.76±4.79)s,fibrinogen were(4.23±1.38),(4.15±1.47)and(3.51±1.25)g·L-1,cumulative incidences of MACE over 12 months were 8.93%,14.28%and 28.57%,the differences were statistically significant between A,B groups and C group(all P<0.05).The adverse drug reactions of three groups were vomiting,dizziness and rash.The total incidences of adverse drug reactions in A,B and C groups were 7.14%,7.14%and 10.71%without significant differences(all P>0.05).Conclusion Rivaroxaban tablets combined with clopidogrel tabets and/or aspirin enteric-coated tablets have a definitive clinical efficacy in the treatment of patients with atrial fibrillation after PCI,without increasing the incidence of adverse drug reactions.