利伐沙班与华法林对肺栓塞患者的有效性和安全性比较

Efficacy and Safety of Rivaroxaban and Warfarin in Patients with Pulmonary Embolism

目的比较利伐沙班与华法林在肺栓塞患者中应用的有效性与安全性。方法选取2016年1月至2016年12月于阜外医院住院诊断为肺栓塞并且接受华法林或利伐沙班抗凝治疗的患者119例。根据患者口服抗凝药物的不同分为华法林组(60例)和利伐沙班组(59例)。比较两组基线资料特征,随访观察并比较两组肺栓塞患者的治疗效果以及出血等安全性终点事件的发生率。结果利伐沙班组慢性肾脏病的患病率高于华法林组(8.5%vs.0%,P=0.027);利伐沙班组既往静脉血栓栓塞史比例高于华法林组(33.9%vs.13.3%,P=0.008)。除此以外,两组间年龄、既往卒中史、高血压、糖尿病、心力衰竭、心肌梗死等基线参数无显著差异。平均随访时间(24±9)个月,共7例(5.9%)患者死亡:华法林组5例(8.3%),利伐沙班组2例(3.4%),组间比较无显著差异(P=0.439)。再住院患者共28例(23.5%),华法林组和利伐沙班组均为14例,组间比较无显著差异(P=0.959)。有效性方面:华法林组5例(8.3%)肺栓塞复发,利伐沙班组3例(5.1%)复发,两组肺栓塞复发率无显著差异(P=0.717)。安全性终点事件,华法林组大出血事件发生3例(5.0%),利伐沙班组4例(6.8%),两组间比较无显著差异(P=0.717)。华法林组小出血事件发生2例(3.3%),利伐沙班组11例(18.6%),利伐沙班组高于华法林组(P=0.007)。结论与华法林相比,利伐沙班用于肺栓塞患者具有类似的有效性和更好的安全性。利伐沙班用药方便,不需要定期监测,可能成为肺栓塞患者更好的选择。

Objective To compare the efficacy and safety of rivaroxaban and warfarin in patients with pulmonary embolism.Methods From January 2016 to December 2016,a total of 119 pulmonary embolism(PE)patients,who received anticoagulant therapy with warfarin or rivaroxaban,were enrolled.All patients were divided into warfarin group or rivaroxaban group according to their drugs.The baseline characteristics of the two groups were compared.The efficacy and safety(endpoint events such as bleeding)were observed and compared between two groups.Results A total of 119 PE patients were enrolled in the study,including 60 patients(50.4%)in warfarin group and 59(49.6%)in rivaroxaban group.The prevalence of chronic kidney disease was higher in rivaroxaban group than that in warfarin group(8.5%vs.0,P=0.027),and the proportion of previous venous thromboembolism history in rivaroxaban group was higher than that in warfarin group(33.9%vs.13.3%,P=0.008).In addition,there was no significant difference in age,history of stroke,hypertension,diabetes,heart failure,myocardial infarction and other baseline parameters between the two groups.During the follow-up period of 24±9 months,totally 8 cases(6.7%)died,including 5 cases(8.3%)in warfarin group and 3 cases(5.1%)in rivaroxaban group(P=0.439).Readmission was occurred in 28 patients(23.5%)and each group has 14 patients(P=0.959).In terms of effectiveness,there were 5 cases(8.3%)of recurrent PE in warfarin group and 3(5.1%)in rivaroxaban group(P=0.717).There were 3 cases(5.0%)of massive hemorrhage observed in warfarin group and 4(6.8%)in rivaroxaban group(P=0.717).Minor bleeding was observed higher in warfarin group than that in rivaroxaban group(3.3 vs.18.6,P=0.007).Conclusion Compared with warfarin,rivaroxaban has similar efficacy and better safety in the treatment of pulmonary embolism.In view of the convenience and no need for regular monitoring,rivaroxaban may be a better choice for patients with PE.