达比加群酯与华法林用于非瓣膜性心房颤动患者抗凝的有效性与安全性比较

摘要

目的:比较达比加群酯与华法林用于非瓣膜性心房颤动(NVAF)患者抗凝的有效性和安全性.方法:回顾性分析360例NVAF患者资料,按用药方案的不同分为对照组(180例)和观察组(180例).对照组患者给予华法林钠片,起始剂量2.5 mg,口服,每日1次,根据国际标准化比值(INR)调整剂量.观察组患者给予达比加群酯胶囊150 mg,每日2次,温水送服,餐时或餐后服用.观察两组患者治疗前与治疗1、3个月后丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)水平、INR及不良反应发生情况.结果:两组患者治疗前后ALT、AST水平比较,差异均无统计学意义(P>0.05).治疗前,两组患者INR比较,差异无统计学意义(P>0.05).治疗1、3个月后,对照组患者INR均显著高于同组治疗前,差异有统计学意义(P<0.05);观察组患者治疗前后比较,差异均无统计学意义(P>0.05),但两组患者INR值均在正常范围内.两组患者不良反应发生率比较,差异无统计学意义(P>0.05).结论:达比加群酯治疗NVAF患者的抗凝有效性显著优于华法林,且两药的安全性相当.%OBJECTIVE:To compare anticoagulant efficacy and safety of dabigatran etexilate and warfarin in the treatment of non-valvular atrial fibrillation(NVAF). METHODS:In retrospective analysis,360 NVAF patients were divided into control group (180 cases)and observation group(180 cases)according to therapy plan. Control group was given Warfarin sodium tablet with ini-tial dose of 2.5 mg orally,once a day,adjusted dosage according to INR. Observation group was given Dabigatran etexilate cap-sule 150 mg with warm water,twice a day,during or after meal. The levels of ALT,AST and INR,the occurrence of ADR were observed in 2 groups before treatment and 1,3 month after treatment. RESULTS:There was no statistical significance in the levels of ALT or AST between 2 groups before and after treatment (P>0.05). Before treatment,there was no statistical significance in INR between 2 groups (P>0.05),1,3 months after treatment,INR in control group was significantly higher than before treat-ment,with statistical significance(P<0.05);there was no statistical significance in the INR of observation group before and after treatment(P>0.05);but INR of 2 groups ranged were in normal range. There was no statistical significance in the incidence of ADR between 2 groups(P>0.05). CONCLUSIONS:Anticoagnlant efficacy of dabigatran etexilate is significantly better than war-farin for NVAF. Both have similar safety.