高龄老年非瓣膜性心房颤动患者应用新型口服抗凝药（NOACs）抗凝治疗有效性及安全性评价研究

发布时间：2018-08-17 13:38

【摘要】：目的:评价高龄老年(≥80岁)非瓣膜性房颤患者应用新型口服抗凝药(NOACs)达比加群、利伐沙班抗凝治疗的有效性及安全性,指导临床用药。方法:纳入2014年6月至2016年6月我科室使用华法林、达比加群、利伐沙班抗凝治疗的高龄老年非瓣膜性房颤患者各50例,达比加群组使用110mg 2次/日,利伐沙班组使用10mg 1次/日,华法林组将国际化标准比值调整至2.0-2.5之间,比较三组间的出血、栓塞事件的发生率,观察所有患者治疗前、治疗后1月、3月、6月血红蛋白、肝肾功能的变化,观察治疗前及治疗后3日、1月、3月、6月相关凝血功能指标的变化。结果:1.华法林组、达比加群组、利伐沙班组组间比较栓塞事件发生率的差异无统计学意义(P0.05);达比加群组与利伐沙班组出血事件发生率的差异无统计学意义(P0.05);达比加群组及利伐沙班组的出血事件发生率均低于华法林组且差异有统计学意义(P0.05)。2.达比加群组血红蛋白、谷丙转氨酶、肌酐等指标用药前后变化无显著性差异,活化部分凝血活酶时间(APTT)用药前(34.25±0.59S)、用药后3日(44.73±2.60S)升高有统计学意义(P0.05),用药后3日、1月、3月、6月有升高趋势,但无统计学意义(P0.05),且均未超过正常值上限的2倍;利伐沙班组血红蛋白、谷丙转氨酶、肌酐用药前后变化无显著性差异,凝血酶原时间(PT)用药前(14.94±0.31S)、用药后3日(18.05±0.58S)升高有统计学意义(P0.05),用药后3日、1月、3月、6月有升高趋势,但无统计学意义(P0.05),且均未超过正常值上限的2倍。结论:1.高龄老年非瓣膜性房颤患者应用NOACs有效性不劣于华法林,安全性优于华法林。2.使用NOACs无需常规监测凝血功能,但当应用于特殊人群(如高龄老年患者)怀疑出血风险升高或出现轻微出血时,使用达比加群患者将APTT、使用利伐沙班患者将PT血药浓度谷值时升高不超过正常值上限的2倍作为安全性指标之一,且要定期监测肾功能,并在用药前计算肌酐清除率。本次研究样本量较小且随访观察时间短,需增加样本量及观察时间进一步证明上述结论。
[Abstract]:OBJECTIVE: To evaluate the efficacy and safety of a new oral anticoagulant (NOACs) dapigat and rivaroxaban in the treatment of non-valvular atrial fibrillation in elderly patients (> 80 years old) and to guide clinical use of the drug.METHODS: Warfarin, dapigat and rivaroxaban were included in our department from June 2014 to June 2016. Fifty patients with atrial fibrillation were treated with 110 mg twice a day in the dabija group, 10 mg once a day in the rivaroxaban group, and 2.0-2.5 in the warfarin group. The incidence of hemorrhage and embolism was compared among the three groups. The changes of hemoglobin, liver and kidney function were observed before treatment, 1 month, 3 months and 6 months after treatment. Results: 1. There was no significant difference in the incidence of embolic events between warfarin group, dabija group and rivaroxaban group (P 0.05); there was no significant difference in the incidence of hemorrhagic events between dabija group and rivaroxaban group (P 0.05). There was no significant difference in hemoglobin, alanine aminotransferase and creatinine between the two groups. Activated partial thromboplastin time (APTT) increased significantly before and after treatment (34.25.59S) and 3 days (44.73.60S) after treatment. Significance (P Significance of calculating (P 0.05), there was an increasing trend in 3 days, 1 month, 3 months and 6 months after treatment, but there was no statistical significance (P 0.05), and they did not exceed the upper limit of the normal value of two times. Conclusion: 1. The effectiveness of NOACs in elderly patients with non-valvular atrial fibrillation is not inferior to warfarin, the safety is better than warfarin. 2. NOACs does not require routine monitoring of blood coagulation function, but when used in elderly patients with non-valvular atrial fibrillat In particular populations (such as elderly patients) suspected of an increased risk of bleeding or mild bleeding, APTT was administered to patients in the dabiga group, and 2 times higher than the upper limit of normal PT concentration in the rifaxaban group. Renal function was monitored regularly and creatinine clearance was calculated before administration. The sample size of this study is small and the follow-up observation time is short. It is necessary to increase the sample size and observation time to further prove the above conclusion.
【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R541.75

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