利伐沙班用于非瓣膜性心房颤动伴肾功能不全患者的效果与安全性

Effect and safety of rivaroxaban in patients with non-valvular atrial fibrillation and renal insufficiency

目的探讨利伐沙班用于非瓣膜性心房颤动(NVAF)伴肾功能不全患者的效果与安全性。方法选择2017年1月~2018年6月于复旦大学附属中山医院青浦分院就诊的非瓣膜性房颤伴肾功能不全患者297例为研究对象,采用随机数字表法分为华法林组(n=148)和利伐沙班组(n=149);华法林组患者给予华法林治疗,利伐沙班组患者给予利伐沙班进行治疗。分析比较两组患者肾功能指标,生存情况,疗效终点事件发生率及安全性终点事件发生率。结果治疗前,两组患者的血肌酐和肌酐清除率的差异无统计学意义;治疗后,两组的血肌酐均显著高于治疗前,且华法林组的血肌酐高于利伐沙班组;肌酐清除率均低于治疗前,且华法林组的肌酐清除率低于利伐沙班组(均P<0.05);华法林组的中位总生存期(OS)为20个月,利伐沙班组的中位OS为20个月,利伐沙班组的死亡风险与华法林组无显著差异(HR=0.940,95%CI:0.714~1.237);华法林组和利伐沙班组在主要终点事件发生方面的差异无统计学意义(HR:0.650;95%CI:0.183~2.303;);华法林组和利伐沙班组在主要安全事件发生方面的差异无统计学意义(HR:0.922;CI:0.581~1.464)。结论非瓣膜性房颤伴肾功能不全患者抗凝治疗中,口服利伐沙班比华法林在延缓肾功能进展方面更为有效,但其在预后生存情况,预防脑卒中、全身性栓塞及出血事件发生方面无显著差异。

AIM To investigate the efficacy and safety of rivaroxaban in patients with non-valvular atrial fibrillation and renal insufficiency.METHODS A total of 297 patients with non-valvular atrial fibrillation and renal insufficiency who were admitted to our hospital from January 2017 to June 2018 were enrolled.By randomized digital table method,the patients were divided into warfarin group(148 cases)and rivaroxaban group(149 cases).Patients in warfarin group were treated with warfarin and patients in rivaroxaban group were treated with rivaroxaban.The coagulation function index,renal function index,survival status,efficacy endpoint event rate and safety endpoint event rate were analyzed and compared between the two groups.RESULTS Before treatment,there was no statistical difference in serum creatinine and creatinine clearance between the two groups,but after treatment,the blood creatinine in both groups was higher than that before treatment and the blood creatinine in warfarin group was higher than that in rivaroxacin group.After treatment,creatinine clearance was lower than that before treatment in both groups,and creatinine clearance in warfarin group was lower than that in rivaroxaban group(P<0.05).The median OS in both groups was 20 months and the risk of death in rivaroxaban group was not significantly different from that in warfarin group(HR=0.940,95%CI:0.714~1.237).In warfarin group,6 patients had stroke and systemic embolic events and 4 patients in rivaroxaban group had a primary endpoint(HR:0.650;CI:0.183~2.303).In warfarin group,37 patients had major safety events,while 35 patients in rivaroxaban group had major safety events(HR:0.922,CI:0.581~1.464).CONCLUSION In patients with non-valvular atrial fibrillation and renal insufficiency,oral rivaroxaban is more effective than warfarin in delaying renal function progression,but there is no significant difference in survival,prevention of stroke,systemic embolism and bleeding events.