高齡老年非瓣膜性心房顫動患者應用新型口服抗凝藥（NOACs）抗凝治療有效性及安全性評價研究
發(fā)布時間：2018-08-17 13:38
【摘要】：目的:評價高齡老年(≥80歲)非瓣膜性房顫患者應用新型口服抗凝藥(NOACs)達比加群、利伐沙班抗凝治療的有效性及安全性,指導臨床用藥。方法:納入2014年6月至2016年6月我科室使用華法林、達比加群、利伐沙班抗凝治療的高齡老年非瓣膜性房顫患者各50例,達比加群組使用110mg 2次/日,利伐沙班組使用10mg 1次/日,華法林組將國際化標準比值調(diào)整至2.0-2.5之間,比較三組間的出血、栓塞事件的發(fā)生率,觀察所有患者治療前、治療后1月、3月、6月血紅蛋白、肝腎功能的變化,觀察治療前及治療后3日、1月、3月、6月相關凝血功能指標的變化。結(jié)果:1.華法林組、達比加群組、利伐沙班組組間比較栓塞事件發(fā)生率的差異無統(tǒng)計學意義(P0.05);達比加群組與利伐沙班組出血事件發(fā)生率的差異無統(tǒng)計學意義(P0.05);達比加群組及利伐沙班組的出血事件發(fā)生率均低于華法林組且差異有統(tǒng)計學意義(P0.05)。2.達比加群組血紅蛋白、谷丙轉(zhuǎn)氨酶、肌酐等指標用藥前后變化無顯著性差異,活化部分凝血活酶時間(APTT)用藥前(34.25±0.59S)、用藥后3日(44.73±2.60S)升高有統(tǒng)計學意義(P0.05),用藥后3日、1月、3月、6月有升高趨勢,但無統(tǒng)計學意義(P0.05),且均未超過正常值上限的2倍;利伐沙班組血紅蛋白、谷丙轉(zhuǎn)氨酶、肌酐用藥前后變化無顯著性差異,凝血酶原時間(PT)用藥前(14.94±0.31S)、用藥后3日(18.05±0.58S)升高有統(tǒng)計學意義(P0.05),用藥后3日、1月、3月、6月有升高趨勢,但無統(tǒng)計學意義(P0.05),且均未超過正常值上限的2倍。結(jié)論:1.高齡老年非瓣膜性房顫患者應用NOACs有效性不劣于華法林,安全性優(yōu)于華法林。2.使用NOACs無需常規(guī)監(jiān)測凝血功能,但當應用于特殊人群(如高齡老年患者)懷疑出血風險升高或出現(xiàn)輕微出血時,使用達比加群患者將APTT、使用利伐沙班患者將PT血藥濃度谷值時升高不超過正常值上限的2倍作為安全性指標之一,且要定期監(jiān)測腎功能,并在用藥前計算肌酐清除率。本次研究樣本量較小且隨訪觀察時間短,需增加樣本量及觀察時間進一步證明上述結(jié)論。
[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.
【學位授予單位】：山西醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R541.75
本文編號：2187807
[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.
【學位授予單位】：山西醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R541.75
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，本文編號：2187807
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