利伐沙班与华法林治疗高龄(≥80岁)非瓣膜性心房颤动患者临床疗效的对比研究

Clinical Effect in Treating Non-valvular Atrial Fibrillation Patients with Advanced Age(≥ 80 Years Old):a Comparison between Rivaroxaban and Warfarin

目的比较利伐沙班与华法林治疗高龄(≥80岁)非瓣膜性心房颤动(AF)患者的临床疗效。方法选取2015年3月—2017年3月大连市第三人民医院收治的高龄(≥80岁)非瓣膜性AF患者86例,采用随机数字表法分为对照组和观察组,每组43例。在常规治疗基础上,对照组患者给予华法林治疗,观察组患者给予利伐沙班治疗,两组患者均连续治疗12个月。比较两组患者治疗前、治疗6个月、治疗12个月抗凝功能指标[包括凝血酶原时间(PT)和D-二聚体]、N末端B型利钠肽前体(NT-proBNP)、简易智能精神状态检查量表(MMSE)评分和日常生活能力量表(ADL)评分;记录两组患者治疗期间血栓栓塞事件、出血事件及不良反应发生情况。结果 (1)两组患者治疗前、治疗6个月、治疗12个月PT、D-二聚体、NT-proBNP、MMSE评分及ADL评分比较,差异无统计学意义(P>0.05)。(2)两组患者治疗期间血栓栓塞事件发生率比较,差异无统计学意义(P>0.05)。(3)观察组患者治疗期间出血事件发生率低于对照组(P<0.05)。(4)两组患者治疗期间胃肠道不适、头痛、眩晕、失眠、皮疹发生率比较,差异无统计学意义(P>0.05)。结论利伐沙班对高龄(≥80岁)非瓣膜性AF患者凝血功能、NT-proBNP、认知功能、日常生活能力的影响及对血栓栓塞事件的预防作用、用药安全性与华法林相似,但利伐沙班可更有效地减少出血事件发生风险。

Objective To compare the clinical effect in treating non-valvular atrial fibrillation patients with advanced age(≥80 years old)between rivaroxaban and warfarin.Methods A total of 86 non-valvular atrial fibrillation patients with advanced age(≥80 years old)were selected in the Third People's Hospital of Dalian from March 2015 to March 2017,and they were divided into control group and observation group according to random number table,each of 43 cases.Based on conventional treatment,patients in control group received warfarin,while patients in observation group received rivaroxaban;both groups continuously treated for 12 months.Index of anti-coagulation function(including PT and D-dimer),NT-proBNP,MMSE score and ADL score were compared between the two groups before treatment,6 and 12 months after treatment,incidence of thromboembolic events,bleeding events and adverse reactions was observed during treatment,respectively.Results (1)No statistically significant differences of PT,D-dimer,NT-proBNP,MMSE score or ADL score was found between the two groups before treatment,6 or 12 months after treatment(P>0.05).(2)No statistically significant differences of incidence of thromboembolic events was found between the two groups during treatment(P>0.05).(3)Incidence of bleeding events in observation group was statistically significantly lower than that in control group during treatment(P<0.05).(4)No statistically significant differences of incidence of gastrointestinal discomfort,headache,dizziness,aypnia or rash was found between the two groups during treatment(P>0.05).Conclusion In non-valvular atrial fibrillation patients with advanced age(≥80 years old),rivaroxaban has similar effect with warfarin on coagulation function,NT-proBNP,cognitive function and activity of daily living,with similar preventive effect on thromboembolic events and safety of drug use,but rivaroxaban can more effectively reduce the risk of bleeding events compared with warfarin.