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

发布时间：2018-12-06 17:48

【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。
[Abstract]:Objective: to compare the efficacy and safety of Levasaban and warfarin in the prevention of thrombotic diseases in the elderly. Methods: 90 elderly patients with high risk of venous thrombosis (mean age (82.4 卤5.5) years) who were hospitalized in our hospital from 2012-03 to 2014-03 were selected. The patients were randomly divided into two groups: rivastaban group (n = 44) and warfarin group (n = 44). 46 patients (38 males and 8 females) in warfarin group were given warfarin orally, and the international standardized ratio (INR),) was stable at 1.6% 2.5. All the patients were followed up for 12 months after corresponding treatment. Hemoglobin, platelet count, coagulation function, endpoint events and liver and kidney function were monitored before treatment for 1 month, 3 months, 6 months and 12 months. The main therapeutic endpoints were death, recurrent or new venous thrombosis, pulmonary embolism and cerebrovascular events, and cardiovascular events. The main safe endpoints included massive bleeding or clinically significant bleeding, and severe deterioration of liver and kidney function. Results: no death occurred in all patients during the study period. The average INR of warfarin group at 1 month, 3 months, 6 months and 12 months was 2.02 卤0.46U 1.98 卤0.54U 2.03 卤0.56 and 2.04 卤0.46respectively. During the follow-up period, there was no significant difference in efficacy and safety between the two groups. There were 7 cases of severe thrombus in warfarin group at 12 months, more than 2 cases in rivastaban group, the difference was not statistically significant. There was no significant difference in hemoglobin, platelet count, coagulation function and liver and kidney function between the two groups. Conclusion: oral rivastaban is an effective method to prevent thromboembolic diseases in the elderly, and 10 mg daily is a safe and effective dose for prevention of thrombotic diseases. The efficacy of rivastaban in preventing thrombotic diseases is similar to that of warfarin. But the treatment is simpler, the compliance is better, the safety is high.
【作者单位】：中国人民解放军总医院南楼心血管内科;武警总医院信息科;
【基金】：解放军总医院临床科研扶持基金(2012FC-CXYY-1003)
【分类号】：R54

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