摘要
目的评价达比加群酯和华法林用于持续心房纤颤(房颤)患者的抗凝治疗的疗效及安全性差异。方法选择2014年1月～2016年1月于沈阳医学院附属中心医院循环科就诊的持续房颤患者112例,随机分为华法林组(56例)和达比加群组(56例),分别给予华法林和达比加群酯用于抗凝治疗,治疗目标为国际标准化比值(INR)2-3,比较两组患者治疗前后的凝血功能,应用Kaplan-Meier法绘制生存曲线,对比两组患者的出血与血栓事件发生情况。结果与治疗前相比,治疗3个月后,华法林组患者凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)和INR均显著升高,差异有统计学意义(P<0.05),凝血酶时间(TT)变化不明显(P>0.05);达比加群组患者APTT和INR均显著升高,差异有统计学意义(P<0.05),PT、 INR变化不明显(P>0.05)。治疗3个月后,达比加群组患者的APTT和TT水平显著高于华法林组(P<0.05),而PT、INR显著低于华法林组(P<0.05)。华法林组患者随访期间发生血栓事件5例(8.93%),达比加群组发生1例血栓事件,Log rank检验显示,两组血栓事件发生风险无统计学差异(HR=0.133,95%CI:0.014～1.278,P=0.081)。华法林组和达比加群组患者随访期间的全因死亡率分别为5.36%和1.79%,Log rank检验显示,两组患者的全因死亡风险无统计学差异(HR=0.329,95%CI:0.046～2.335,P=0.311)。华法林组和达比加群组患者随访期间分别发生出血事件5例(12.50%)和2例(3.57%),两组间差异无统计学意义(χ2=0.610,P=0.435),两组患者均未出现致命性出血事件;两组患者的不良反应发生率分别为26.79%和19.64%,两组间差异无统计学意义(χ2=0.801,P=0.371)。结论在持续房颤患者的抗凝治疗中应用达比加群酯的抗凝效果明显优于华法林,两种药物的血栓与出血事件发生风险相似,安全性也不存在明显差异。
Objective To evaluate the efficacy and safety of dabigatran and warfarin for anticoagulant therapy in patients with persistent atrial fibrillation.Methods A total of112patients with persistent atrial fibrillation who were admitted to the Central Hospital Affiliated to Shenyang Medical College from January2014to January2016were randomly divided into warfarin group(56cases)and dabigatran group(56cases),and the patients were given warfarin and dabigatran for anticoagulant therapy respectively.The treatment target was international normalized ratio(INR)2~3.The coagulation function before and after treatment was compared between two groups.Kaplan-Meier method was used to draw the survival curve,and the incidence of bleeding and thrombosis in the two groups of patients were analyzed.Results(1)Compared with before treatment,the PT,APTT and INR of the warfarin group were significantly increased after3months of treatment,the difference was statistically significant(P<0.05),and the change of TT was not significant(P>0.05).The APTT and INR of the patients in the dabigatran group were significantly increased(P<0.05),and the changes of PT and INR were not significant(P>0.05).After3months of treatment,the levels of APTT and TT in the dabigatran group were significantly higher than those in the warfarin group(P<0.05),while the PT and INR were significantly lower than those in the warfarin group(P<0.05).(2)There were5cases of thrombosis in the warfarin group(8.93%),and1case of thrombosis in the dabigatran group.Log rank test showed no significant difference in the risk of thrombosis between the two groups(HR=0.133,95%CI:0.014~1.278,P=0.081).(3)The all-cause mortality during follow-up in the warfarin group and the dabigatran group was5.36%and1.79%,respectively.Log rank test showed that there was no significant difference in all-cause mortality between the two groups(HR=0.329,95%CI:0.046~2.335,P=0.311).(4)There were5cases(12.50%)and2cases(3.57%)of bleeding events in the warfarin group and the Dabigatran group(χ^2=0.610,P=0.435).T
作者
王微
杨帆
田志鹏
李立杰
李敬
韩冰
Wang Wei;Yang Fan;Tian Zhipeng;Li Lijie;Li Jing;Han Bing(Department of Circulation,Central Hospital Affiliated to Shenyang Medical College,Shenyang 110024,China)
出处
《中国循证心血管医学杂志》
2018年第11期1385-1388,1392,共5页
Chinese Journal of Evidence-Based Cardiovascular Medicine
关键词
心房纤颤
抗凝治疗
达比加群酯
华法林
血栓事件
Atrial fibrillation
Anticoagulation
Dabigatran
Warfarin
Thrombotic events
