达比加群酯预防性抗凝治疗老年非瓣膜性心房纤颤30例临床观察

Clinical observation of dabigatran etexilate in prophylactic anticoagulation of elderly nonvalvular atrial fibrillation: 30 cases

目的观察达比加群酯预防抗凝治疗老年非瓣膜性心房纤颤的疗效及安全性。方法 60例非瓣膜性房颤患者随机分为达比加群组和华法林组,每组30例。达比加群组给予达比加群酯110 mg口服,每天2次;华法林组给予调整剂量的华法林治疗。观察两组患者服药1、3个月后的相关凝血功能指标改变及药物的不良反应。随访2a,对比两组栓塞、出血及终点事件的发生率。结果治疗1、3个月后,两组患者凝血酶原时间(PT)、活化的部分凝血活酶时间(APTT)及凝血酶时间(TT)均较治疗前延长(P<0.05);国际标准化比值(INR)亦较治疗前升高(P<0.05);并且以3个月后更为显著(P<0.05)。两组同一时间点的上述指标的差异无统计学意义(P>0.05)。治疗3个月内,两组不良反应发生率的差异均无统计学意义(均P>0.05)。随访2a,达比加群组的短暂性脑缺血、脑梗死及上消化道出血的总发生率较华法林组低(P<0.01)。结论老年非瓣膜性房颤患者应用小剂量达比加群酯进行抗凝治疗安全有效。

Objective To observe the efficacy and safety of dabigatran etexilate in preventive and anticoagulation treatment of non-valvular atrial fibrillation. Methods Sixty cases of patients with non-valvular atrial fibrillation were divided into Dabigatran Etexilate Group and Warfarin Group, 30 cases in each group. Dabigatran Etexilate Group was orally administered with 110mg dabigatran etexilate, bid; Warfarin Group was orally administered with dabigatran etexilate with adjusted dose. The change in coagulation indexes and adverse drug reactions 1 month and 3 months after medication were observed. After a follow-up of 2a, the incidence of embolism, bleeding and outcome event was compared between the two groups. Results After treatment for 1 month and 3 months, prothrombin time （PT）, activated partial thromboplastin time （APTT） and thrombin time （TT） were prolonged compared with those before treatment （P〈0.05）; the international normalized ratio （INR） was increased compared with that before treatment （P〈0.05）; and the increase was more significant in those receiving treatment for 3 months （P〈0.05）. There was no statistical difference in above indicators of the same point between the two groups （P〉0.05）. Within the three months of treatment, there was no statistical difference in the incidence of adverse reactions between the two groups （P〉0.05）. After a follow-up of 2a, the overall incidence of TIA, cerebral embolism, cerebral hemorrhage, and upper gastrointestinal bleeding was lower than that of Warfarin Group （P〈0.01）. Conclusion Dabigatran etexilate in low dose for anticoagulation treatment is effective and safe for senile patients with nonvalvular AF.