达比加群酯预防房颤患者卒中的临床研究

Dabigatran for prevention of stroke in atrial fibrillation patients: a clinical trial

目的观察达比加群酯预防房颤患者卒中的疗效及安全性。方法纳入房颤患者80例均符合抗凝治疗指征。按照奇偶数法随机分为观察组(n=40)和对照组(n=40)。观察组给予达比加群酯110 mg,2次/d;对照组给予华法林2.5 mg/d,并定期测定国际标准化比值(INR),根据INR调整剂量。两组疗程均为6个月。记录两组患者卒中、全身性栓塞和大出血发生情况。两组患者出院时检查凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FIB)和D-二聚体等凝血指标。结果观察组患者卒中/全身性栓塞的发生率为17.5%,对照组为37.5%,两组患者卒中/全身性栓塞发生率有统计学差异(P<0.05);观察组患者大出血发生率显著低于对照组,差异有统计学意义(P<0.05)。两组患者凝血功能指标差异均无统计学意义。治疗后,两组血脂水平均较治疗前显著改善,同组治疗前后比较差异有统计学意义(P<0.05);且观察组血脂水平改善更为明显,组间差异有统计学意义(P<0.05)。结论与华法林比较,对有房颤患者行抗凝治疗达比加群酯具备同等疗效,且安全性更高。

Objective To observe the efficacy and safety of dabigatran for stroke prevention in atrial fibrillation patients.Methods A total of 80 atrial fibrillation patients with indications to anticoagulant therapy were enrolled. They were randomly divided into observation group (n=40) and control group (n=40). The observation group was administered dabigatran 110 mg, twice a day; the control group was administered warfarin 2.5 mg/d, then the international normalized ratio (INR) was determined periodically. The dose of warfarin was adjusted according to INR. Both treatment course in the two groups were six months. We recorded the incidence of stroke, systemic embolism and massive hemorrhage in two groups, and compared the level of discharge PT, activated partial thromboplastin time (APTT), fibrinogen and D-dimer between two groups. Results The incidence of stroke/systemic embolism in the observation group was 17.5%, and in the control group was 37.5%, there was significant difference in the incidence of stroke/systemic embolism between two groups (P<0.05). The incidence of bleeding in the observation group was significantly lower than the control group (P<0.05). There was no significant difference in coagulation function between two groups. After treatment, the blood lipid levels of the two groups were significantly improved compared with those before treatment (P<0.05), and the improvement of blood lipid level in the observation group was more significant (P<0.05).Conclusion Compared with warfarin, dabigatran has the same efficacy and higher safety in patients with atrial fibrillation.