达比加群酯联合阿司匹林片治疗非瓣膜性房颤患者的疗效和安全性

    Clinical observation of dabigatran combined with aspirin in treatment of non-valvular atrial fibrillation

    • 摘要: 目的 观察达比加群酯联合阿司匹林治疗非瓣膜性房颤的疗效和安全性。方法 将非瓣膜性心房颤动84例患者随机分为联合用药组(达比加群酯联合阿司匹林)、达比加群酯组和华法林组,分别予以抗凝治疗。随访观察1年,对比3组短暂性脑缺血发作(TIA)、脑栓塞、肺栓塞、脑出血、上消化道出血、死亡等终点事件,比较3组临床疗效;观察患者服药后相关凝血功能指标及药物的安全性。结果 联合用药组TIA、脑栓塞发生率明显低于华法林组(P<0.05),但稍高于达比加群酯组,差异无统计学意义;联合用药组脑出血、上消化道出血明显高于其余两组(P<0.05);达比加群酯组患者TIA、脑栓塞、脑出血、上消化道出血的发生率均显著低于华法林组(P<0.05);3组患者治疗前后的凝血酶原时间(PT)、凝血酶时间(TT)、国际标准化比值(INR)、活化的部分凝血活酶时间(APTT)治疗后均较治疗前不同程度升高,差异均有统计学意义(P<0.05);3组患者均无严重出血、肝肾损害等不良事件发生。结论 达比加群酯联合阿司匹林可有效降低非瓣膜性房颤患者卒中、栓塞的风险,但疗效并无优于达比加群酯单药治疗,且出血风险增加。

       

      Abstract: AIM To observe the efficacy and safety of dabigatran combined with aspirin in the treatment of non-valvular atrial fibrillation. METHODS Eighty-four cases of patients with non-valvular atrial fibrillation from April 2012 to March 2013 were divided into observation group (dabigatran combined with aspirin), dabigatran group (DE group) and warfarin group for anti-coagulation. The incidence of transient ischemic attack (TIA), cerebral embolism, pulmonary embolism, cerebral hemorrhage, upper gastrointestinal bleeding, death and other end point events were observed with 1-year follow-up. Related coagulation parameters and product safety were also observed. RESULTS The incidence of TIA and cerebral embolism in observation group was significantly lower than that in the warfarin group (P<0.05). No significant difference was seen between observation group and DE group. The incidence of upper gastrointestinal bleeding in the observation group was significantly higher than in the DE group and warfarin group (P<0.05). The incidence of TIA, cerebral embolism, cerebral hemorrhage, and upper gastrointestinal bleeding in DE group were significantly lower than those in warfarin group (P<0.05). The coagulation parameters of prothrombin time (PT), thrombin time (TT), international standardization ratio (INR) and activation of blood coagulation time (APTT) were significantly increased after treatment in all three groups (P<0.05). No adverse events such as serious hemorrhage, liver and kidney damage occurred. CONCLUSION Dabigatran combined with aspirin can effectively decrease the incidence of stroke and embolism in patients with non-valvular atrial fibrillation. The efficacy of combined therapy is not superior to that of dabigatran alone and has an increased risk of bleeding.

       

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