2019 年第 6 期 第 14 卷

达比加群酯与华法林对老年非瓣膜性心房颤动患者抗凝治疗的有效性和安全性比较

Effectiveness and safety of dabigatran etexilate and warfarin in anticoagulant therapy for elderly patients with non-valvular atrial fibrillation

作者：尹其云胡桃红

英文作者：

单位：102300北京市门头沟区中医医院心内科(尹其云)；100088北京，中国人民解放军火箭军特色医学中心心内科(胡桃红)

英文单位：

关键词：非瓣膜性心房颤动；达比加群酯；华法林

英文关键词：

• 摘要：

• 【摘要】目的    比较达比加群酯与华法林对老年非瓣膜性心房颤动患者抗凝治疗的有效性及安全性。方法    选取2016年1月至2017年12月在北京市门头沟区中医医院心内科治疗的110例老年非瓣膜性心房颤动患者，应用随机数字表法分为达比加群酯组和华法林组，每组55例。其中达比加群酯组抗凝治疗给予达比加群酯150 mg，2次/d，餐后服用。华法林组抗凝治疗给予华法林3 mg，1次/d口服，根据国际标准化比值调整剂量。所有患者随访1年，比较2组患者血栓栓塞事件及出血事件发生率。结果    随访过程中，达比加群酯组有3例（5.5%）发生血栓栓塞事件，其中1例缺血性脑卒中，2例下肢静脉栓塞；华法林组有4例（7.3%）发生血栓栓塞事件，其中1例缺血性脑卒中，3例下肢静脉栓塞，2组患者血栓栓塞事件发生率比较，差异无统计学意义（χ2=0.150，P=0.080）。在出血事件方面，达比加群酯组有5例（9.1%）发生出血事件，其中消化道出血1例，皮下出血2例，牙龈出血2例；而华法林组共有18例（32.7%）发生出血事件，其中脑出血1例，消化道出血3例，皮下出血5例，鼻出血4例，牙龈出血5例，达比加群酯组出血事件发生率低于华法林组，差异有统计学意义（χ2=4.758，P=0.026）。结论    达比加群酯在老年非瓣膜性心房颤动患者长期抗凝治疗中，其有效性与华法林相当，但其安全性明显优于华法林。

• 【Abstract】Objective    To compare the effectiveness and safety between dabigatran etexilate and warfarin in anticoagulant treatment for elderly patients with non-valvular atrial fibrillation. Methods    A total of 110 elderly patients with non-valvular atrial fibrillation admitted to Chinese Medicine Hospital of Mentougou District, Beijing from January 2016 to December 2017 were randomly assigned to dabigatran etexilate group and warfarin group, with 55 patients in each group. The dabigatran etexilate group took dabigatran etexilate 150 mg twice per day. The warfarin group took warfarin 3 mg once per day initially with dose adjusted according to the international normalized ratio. All patients were followed up for 1 year; incidences of thromboembolism and bleeding events were analyzed. Results    During follow-up, thromboembolism occurred in 3 cases(5.5%) in dabigatran etexilate group, including 1 case of ischemic stroke and 2 cases of lower extremity venous embolism; 4 cases(7.3%) in warfarin group had thromboembolism, including 1 case of ischemic stroke and 3 cases of lower extremity venous embolism. There was no significant difference of the incidence of thromboembolism between groups(χ2=0.150, P=0.080). There were 5 cases(9.1%) of bleeding events in dabigatran etexilate group, including 1 case of gastrointestinal hemorrhage, 2 cases of subcutaneous hemorrhage and 2 cases of gingival hemorrhage. Warfarin group had 18 cases(32.7%) of bleeding events, including 1 case of cerebral hemorrhage, 3 cases of gastrointestinal hemorrhage, 5 cases of subcutaneous hemorrhage, 4 cases of epistaxis and 5 cases of gingival hemorrhage. Incidence of bleeding events in dabigatran etexilate group was significantly lower than that in warfarin group(χ2=4.758, P=0.026). Conclusion    Dabigatran etexilate shows comparable effectiveness and better safety compared to warfarin in long-term anticoagulant therapy for elderly patients with non-valvular atrial fibrillation.