利伐沙班与达比加群用于非瓣膜性心房颤动患者卒中预防的效果比较

Comparison of rivaroxaban and dabigatran in the prevention of stroke in patients with nonvalvular atrial fibrillation

目的对比分析利伐沙班与达比加群用于非瓣膜性心房颤动患者卒中预防的效果。方法选取北京市大兴区人民医院2016年8月~2018年4月收治的349例非瓣膜性心房颤动患者,随机数表法分为2组,观察组(175例)采用达比加群(110 mg/次,bid)治疗,对照组(174例)采用利伐沙班(20 mg/次,qd)治疗,治疗6个月后开始随访,持续随访12个月,比较两组患者栓塞事件、出血事件、肝肾功能及不良反应。结果观察组和对照组分别有3例和2例患者中途退出研究。其余患者无死亡发生,卒中、下肢静脉栓塞、肺栓塞及心肌梗死发生率组间比较差异均无统计学意义(P> 0.05)。两组患者均无严重出血发生,非严重临床相关出血和轻微出血发生率组间比较差异无统计学意义(P> 0.05)。治疗前后两组患者肌酐、尿素氮、总胆红素和转氨酶水平无明显变化,组间比较无统计学意义(P> 0.05)。两组均有患者发生头晕头痛、消化道症状、皮疹和失眠等不良反应,但各不良反应组间比较差异无统计学意义(P> 0.05)。结论利伐沙班和达比加群用于非瓣膜性心房颤动患者卒中预防时疗效和安全性相近。

Objective To comparative analyze the efficacy and safety of rivaroxaban and dabigatran in the prevention of stroke in patients with nonvalvular atrial fibrillation.Methods 344 patients with non valvular atrial fibrillation admitted to the hospital from August 2016 to April 2018 were randomly divided into two groups.The observation group(175 cases,57-72 years old)was treated with dabigatran group,110 mg/time,bid,and the control group(174 cases,58-73 years old)was treated with rivaroxaban 20 mg/次 time,qd.The patients were followed up for 6 months after treatment,and the embolization events,bleeding events,liver and kidney functions and adverse reactions were observed.The embolization events,bleeding events,liver and kidney functions and adverse reactions between the two groups were compared in 12 months.Results Three patients in the observation group and two patients in the control group quit the study.There was no significant difference in the incidence of stroke,lower extremity vein embolism,pulmonary embolism and myocardial infarction(P > 0.05).There was no significant difference between the two groups(P >0.05).There were no significant changes in creatinine,urea nitrogen,total bilirubin and transaminase between the two groups before and after treatment(P > 0.05).There were adverse reactions such as dizziness,headache,gastrointestinal symptoms,rash and insomnia in both groups,but there was no significant difference between the two groups(P > 0.05).Conclusion The efficacy and safety of rivaroxaban and dabigatran in the prevention of stroke in patients with nonvalvular atrial fibrillation are similar.