老年非瓣膜病心房颤动患者应用达比加群酯抗凝治疗的观察研究

Observational study of dabigatran on the elderly with non-valvular atrial fibrillation

目的观察分析老年非瓣膜病心房颤动患者应用达比加群酯抗凝治疗的安全性。方法纳入2015年9月至2017年4月在阜外医院诊治的服用达比加群酯抗凝治疗的非瓣膜病心房颤动老年患者100例,服用达比加群酯110mg每日两次抗凝。收集患者临床资料。随访记录不良临床事件。根据有无出血分为出血事件组及非出血事件组,分析两组间基线数据的差异。结果入组患者平均年龄(72.72±7.10)岁,男性55例。平均CHADS2 (3.61±1.48)分,平均HASBLED评分(1.95±0.81)分,平均随访时间(6.87±4.06)个月。随访发现无患者发生缺血性脑卒中、短暂性脑缺血发作、系统性栓塞、急性心肌梗死及再入院。无患者发生大出血,18例患者发生小出血(18%)。出血事件组CHADS2评分较高(P=0.077);同时服用ACEI类药物比例较高(P=0.033);同时服用ARB类药物比例较低(P=0.011);同时服用地高辛比例较高(P=0.018);血清白蛋白水平较低(P=0.039)。31例患者有复查血清学指标,发现随访时凝血酶原时间延长(P=0.026)、凝血酶原活动度降低(P=0.001)、INR增加(P=0.039)、活化部分凝血活酶时间(APTT)延长。(P<0.001)、凝血酶时间延长(P<0.001)及血清白蛋白水平升高(P=0.028)。结论本研究显示中国老年非瓣膜病房颤患者应用达比加群酯110 mg每日两次预防卒中,卒中及大出血风险低,小出血发生率18%,联合应用地高辛及血清白蛋白水平偏低可引起出血风险增加。

Objective To evaluate the safety of dabigatran on the elderly with non-valvular atrial fibrillation(NVAF). Methods 100 Consecutive old patients with NVAF who received dabigatran 110 mg bid in Fuwai Hospital from September 2015 to April 2017 were enrolled. Demographics,clinical characteristics of these patients were collected. The adverse events at follow up were collected. According to whether there was bleeding or not, the patients were divided into two groups. The differences between the two groups were analyzed. Results The mean age of patients was(72.72 ±7.10) years. 55 out of the patients were male. The average CHADS2 score was 3.61±1.48, and the average HASBLED score wasl.95 ± 0.81.The mean follow-up time was(6.87 ± 4.06) months.No patient suffered ischemic stroke,transient ischemic attack, systematic thromboembolism,myocardial infarction,and re-hospitalization. No patient suffered major bleeding. 18 patients suffered minor bleeding( 18%).CHADS2 score was higher in the bleeding event group(P=0.077).A high proportion of ACEI drugs were taken(P=0.033).The proportion of ARB drugs taken was low(P=0.011).A high proportion of digoxin was taken at the same time(P=0.018). Serum albumin levels were low(P=0.039). Patients suffering minor bleeding had a prolonged prothrombin time(P=0.026), decreased prothrombin activity(P=0.001), elevated INR(P=0.039), prolonged activated partial thromboplastin time(P<0.001), prolonged thrombin time(P<0.001) and increased serum albumin level(P=0.028). Conclusion This study showed that Dabigatran 110 mg twice one day used for the senior patients with NVAF with low risk of stroke and massive hemorrhage, and the incidence of minor hemorrhage is 18%.Combined use of digoxin and low serum albumin levels can lead to increased risk of bleeding.