80岁及以上心房颤动患者低强度抗凝治疗的安全性和疗效观察

目的 评价年龄80岁及以上非瓣膜性心房颤动患者低强度抗凝治疗的疗效和安全性.方法入选年龄80岁及以上住院非瓣膜性心房颤动患者180例,随机抽签分为低强度和标准强度华法林抗凝治疗,低强度组目标国际标准化比值(INR)1.6～2.0,标准强度组目标INR 2.0～3.0.主要观察终点为两组患者随访期间各种出血并发症及各种栓塞事件发生率;次要观察为INR达标需要的华法林剂量,随访中INR＞3.0的测定次数.结果 两组患者均在半个月内达标,其后随访1年,随访期间低强度组和标准强度组血栓栓塞事件发生率分别为4.4%(4/90)与3.3%(3/90),差异无统计学意义(P＞0.05).但各种出血事件低强度组低于标准强度组,分别为5.6%(5/90)与16.7%(15/90),差异有统计学意义(P＜0.05),同时华法林使用剂量低强度组低于标准强度组,分别为(1.55±0.63)mg与(2.31±0.57)mg,差异有统计学意义(P＜0.05),随访中INR＞3.0的次数低强度组亦少于标准强度组(P＜0.05).结论 在年龄80岁及以上非瓣膜性心房颤动患者中,采用目标INR1.6～2.0低强度抗凝治疗,较常规标准抗凝治疗疗效差异无统计学意义,出血事件及风险明显减少.

Abstract：

Objective To investigate the effectiveness and safety of low-intensity warfarin anticoagulation in over 80-year-old patients with nonvascular atrial fibrillation (NVAF). Methods The 180 NVAF patients aged over 80 years were randomly assigned into 2 groups: 90 patients in lowintensity warfarin anticoagulation group (target value of INR 1.6-2.0), the other 90 patients in standard-intensity warfarin anticoagulation group (target value of INR 2. 0-3.0). All patients were followed up in outpatient-department for one year. Main outcome measures included the incidence rates of bleeding and thromboembolic events, and secondary outcome measures included the warfarin dosage and times of INR＞3.0. Results The incidence rate of thromboembolic events was 4.4% (4/90) in low-intensity group and 3.3% (3/90) in standard-intensity group with no statistically significant difference between these two groups (P＞0. 05). However, the incidence rate of hemorrhage was significantly lower in low-intensity group than in standard-intensity group 5.6% (5/90) vs. 16.7%(15/90), P＜0. 05]. Meanwhile the warfarin dosage was significantly lower in low-intensity group than in standard-intensity group (1. 55±0. 63) mg vs. (2.31±0.57) mg, P＜0.05]. The times of INR＞3.0 were less in low-intensity group than in standard-intensity group (P＜0. 05). Conclusions Therapy with low-intensity warfarin anticoagulation in NVAF patients aged over 80 years may be equally effective as, but safer than that with standard-intensity warfarin.

Effectiveness and safety of low-intensity warfarin anticoagulation in patients with nonvascular atrial fibrillation aged 80 years old and over

Objective To investigate the effectiveness and safety of low-intensity warfarin anticoagulation in over 80-year-old patients with nonvascular atrial fibrillation (NVAF). Methods The 180 NVAF patients aged over 80 years were randomly assigned into 2 groups: 90 patients in lowintensity warfarin anticoagulation group (target value of INR 1.6-2.0), the other 90 patients in standard-intensity warfarin anticoagulation group (target value of INR 2. 0-3.0). All patients were followed up in outpatient-department for one year. Main outcome measures included the incidence rates of bleeding and thromboembolic events, and secondary outcome measures included the warfarin dosage and times of INR＞3.0. Results The incidence rate of thromboembolic events was 4.4% (4/90) in low-intensity group and 3.3% (3/90) in standard-intensity group with no statistically significant difference between these two groups (P＞0. 05). However, the incidence rate of hemorrhage was significantly lower in low-intensity group than in standard-intensity group 5.6% (5/90) vs. 16.7%(15/90), P＜0. 05]. Meanwhile the warfarin dosage was significantly lower in low-intensity group than in standard-intensity group (1. 55±0. 63) mg vs. (2.31±0.57) mg, P＜0.05]. The times of INR＞3.0 were less in low-intensity group than in standard-intensity group (P＜0. 05). Conclusions Therapy with low-intensity warfarin anticoagulation in NVAF patients aged over 80 years may be equally effective as, but safer than that with standard-intensity warfarin.