利伐沙班预防高龄老年血栓性疾病的有效性和安全性研究

摘要

目的:对比研究利伐沙班和华法林预防高龄老年血栓性疾病的有效性和安全性.方法:选取2012-03至2014-03在我院住院治疗的老年静脉血栓高危患者90例,平均年龄(82.4±5.5)岁.入选患者随机分为利伐沙班组和华法林组,利伐沙班组44例,男34例,女10例,给予口服利伐沙班10 mg,1次/d;华法林组46例,男38例,女8例,给予口服华法林,并监测国际标准化比值(INR),使其稳定在1.6~2.5.所有入选患者接受相应治疗后随访观察12个月,监测治疗前、治疗1个月、3个月、6个月、12个月时血红蛋白、血小板计数、凝血功能、终点事件及肝肾功能.试验中主要疗效终点是全因死亡,再发或新发静脉血栓,肺栓塞和脑血管事件,心血管事件;主要安全终点包括大出血或有临床意义的出血,肝肾功能严重恶化.结果:所有入选患者研究期内均未出现死亡.华法林组在治疗1个月、3个月、6个月和12个月时平均INR分别为2.02±0.46、1.98±0.54、2.03±0.56和2.04±0.46.随访观察期间,两组间疗效性和安全性差异无统计学意义,华法林组12个月时发生严重血栓事件7例,多于利伐沙班组2例,差异无统计学意义.血红蛋白、血小板计数、凝血功能和肝肾功能在利伐沙班组和华法林组随访观察期间差异无统计学意义.结论:利伐沙班口服是预防高龄老年血栓栓塞性疾病的有效方法,每日10 mg利伐沙班是预防血栓性疾病的安全有效剂量,利伐沙班预防血栓性疾病的疗效与华法林相当,但治疗更简便、依从性更好、安全性高.%Objective: To compare the efifcacy and safety of rivaroxaban and warfarin on thrombolytic disease prevention in very elderly patients. Methods: A total of 90 patients with high risk of venous thrombosis treated in our hospital from 2012-03 to 2014-03 were enrolled. The patients' mean age was (82.4±5.5) years and randomized into 2 groups: Rivaroxaban group, patients received oral rivaroxaban 10 mg/day,n=44 including 34 male and 10 female; Warfarin group, patients received oral warfarin, INR was monitored and kept at stable level of 1.6-2.5,n=46 including 38 male and 8 female. All patients were followed-up for 12 months. Hemoglobin and platelet levels, coagulation, liver and kidney functions, end point events were monitored before and 1, 3, 6, 12 months after treatment. Major efficacy endpoints included all-cause death, recurrent or new onset of venous thrombosis, pulmonary embolism, cerebral and cardiovascular events; major safety endpoints included massive hemorrhages, clinically relevant bleeding and worsening of liver, kidney functions. Results: No patient died during follow-up period. The average INRs in Warfarin group were (2.02±0.46), (1.98±0.54), (2.03±0.56) and (2.04±0.46) at 1, 3, 6 and 12 months of treatment. Efficacy and safety were similar between 2 groups, Warfarin group had 7 patients with massive hemorrhages at 12 months of treatment and it was 2 patients more than that in Rivaroxaban group which had no statistic meaning. Hemoglobin and platelet levels, coagulation, liver and kidney functions were similar between 2 groups.Conclusion: Oral rivaroxaban was effective for preventing thromboembolic disease in very elderly patients, 10 mg/day was a safe dose; efifcacy of rivaroxaban was similar to warfarin while it was easier to use and with better compliance.