达比加群酯抗凝治疗非瓣膜性房颤90例疗效及安全性评价  

Evaluation on the Efficacy and Safety of Pradaxa on Non-Valvular Atrial Fibrillation Anticoagulation Therapy in 90 Cases

作　　者：左晋[1] 高原[1] 花焱[1] 许麾[1] 于建[1] 刘琪[1] 鲁媛瑗 杨思佳[1] 

机构地区：[1]中国人民解放军海军总医院,北京100037

出　　处：《中国药业》2015年第7期42-43,共2页China Pharmaceuticals

摘　　要：目的评价达比加群酯用于非瓣膜性房颤抗凝治疗的疗效及安全性。方法将180例非瓣膜性房颤患者随机分为对照组和观察组,各90例,对照组采用标准计量华法林抗凝治疗,观察组采用达比加群酯抗凝治疗。分别于治疗前、治疗后1个月和治疗后3个月,观察两组患者肝功能和国际标准化比值(INR),同时观察患者动脉血管栓塞事件(卒中、肢体动脉栓塞、肠系膜动脉栓塞等)发生情况。观察两组治疗过程中出血发生率(包括颅内出血和胃肠道出血)以评价其安全性。结果两组患者治疗过程中丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)及总胆红素(TBIL)等肝功能指标间未见显著性差异;治疗后1个月及3个月对照组患者INR指标均较观察组显著升高;两组患者动脉血管栓塞事件发生率比较未见显著性差异(12.22%比10.00%,P>0.05),与对照组相比,观察组患者不良发应发生率显著降低(2.22%比10.00%,P<0.05)。结论达比加群酯治疗非瓣膜性房颤安全、有效,还能降低患者治疗过程中出血发生率。Objective To evaluation the efficacy and safety of Pradaxa in the non-valvular atrial fibrillation anticoagulation therapy.Methods 180 patients with non-valvular atrial fibrillation were randomly divided into the control group and the observation group,with 90 patients each group.The control group adopted the standard measurement of warfarin anticoagulation therapy,while the observa-tion group was treated with the Pradaxa anticoagulant therapy.The liver function and international normalized ratio（INR）before treat-ment,at 1,3 months after treatment were observed in the two groups,at the same time the arterial thromboembolism events（apoplexy,limb and trunk arterial embolism,mesenteric artery embolism） occurrence situation was observed.In addition,the occurrence rate of bleeding including intracranial hemorrhage and gastrointestinal bleeding during the treatment process were observed in the two groups for evaluating its safety.Results The liver function indexes of ALT,AST and TBIL had no obvious differences during the treatment process between the two group.In the aspect of the INR detection,this index after 1-,3-month treatment in the control group was signifi-cantly increased compared with the observation group.The occurrence rate of arterial vascular embolism events had no statistical dif-ference between the two groups（12.22% vs.10.00%,P〉0.05）.Compared with the control group,the occurrence rate of adverse re-actions in the observation group was significantly reduced compared with the control group（2.22% vs.10.00%,P〈0.05）.Conclusion Pradaxa is safe and effective in the treatment of non-valvular atrial fibrillation and can reduce the incidence of bleeding during the treatment process.

关 键 词：达比加群酯 非瓣膜性房颤 抗凝治疗 华法林 

分 类 号：R969.4[医药卫生—药理学] R973.2[医药卫生—药学]