[1]胡忠慧,姜云生,王肃.利伐沙班用于持续性心房颤动合并2型糖尿病高龄患者抗凝治疗安全性的研究[J].国际内分泌代谢杂志,2021,41(04):327-331.[doi:10.3760/cma.j.cn121383-20210102-01002]
 Hu Zhonghui,Jiang Yunsheng,Wang Su..Clinical study on the safety of rivaroxaban in elderly patients with persistent atrial fibrillation and type 2 diabetes mellitus[J].International Journal of Endocrinology and Metabolism,2021,41(04):327-331.[doi:10.3760/cma.j.cn121383-20210102-01002]
点击复制

利伐沙班用于持续性心房颤动合并2型糖尿病高龄患者抗凝治疗安全性的研究()
分享到:

《国际内分泌代谢杂志》[ISSN:1673-4157/CN:12-1383/R]

卷:
41
期数:
2021年04期
页码:
327-331
栏目:
论著
出版日期:
2021-07-20

文章信息/Info

Title:
Clinical study on the safety of rivaroxaban in elderly patients with persistent atrial fibrillation and type 2 diabetes mellitus
作者:
胡忠慧姜云生王肃
天津市第五中心医院内分泌科 300450
Author(s):
Hu Zhonghui Jiang Yunsheng Wang Su.
Department of Endocrinology, the Fifth Central Hospital of Tianjin, Tianjin 300450, China
关键词:
利伐沙班 持续性心房颤动 抗凝治疗 高龄 2型糖尿病
Keywords:
Rivaroxaban Persistent atrial fibrillation Anticoagulation therapy Elderly patients Type 2 diabetes mellitus
DOI:
10.3760/cma.j.cn121383-20210102-01002
摘要:
目的 观察新型口服抗凝药利伐沙班用于高龄(>80岁)患者持续性心房颤动(PerAF)合并2型糖尿病抗凝治疗的安全性和有效性。方法 选取2014年9月至2018年12月于天津市第五中心医院门诊就诊的高龄PerAF合并2型糖尿病患者共141例,118例患者完成随访,入选本研究,患者随机分为利伐沙班组(A组,n=59)和对照组(口服华法林,B组,n=59),收集两组患者的基线资料,进行CHA2DS2-VASc、HAS-BLED评分,随访1年,监测国际标准化比值(INR)水平,比较两组患者出血、栓塞事件的发生率。结果 两组患者基线临床资料中性别、年龄、CHA2DS2-VASc评分、HAS-BLED评分、体重指数、血钾、估算的肾小球滤过率、尿酸、糖化血红蛋白A1c(HbA1c)、超声心动图参数差异无统计学意义(P均>0.05); 两组患者糖尿病病史差异有统计学意义(P=0.016)。随访1年,两组牙龈出血、皮肤瘀斑、咳血、呕血、黑便、尿血、脑出血、脑栓塞、周围动脉栓塞的发生率无差别(P均>0.05)。A组出血总发生率20.3%,B组出血总发生率33.9%,其中B组发生1例致命性脑出血,两组患者总体出血的发生率差别无统计学意义(P=0.098)。两组患者均无血栓栓塞事件发生。结论 利伐沙班可用于高龄患者PerAF合并2型糖尿病抗凝治疗,与华法林安全性相似。
Abstract:
Objective To observe the efficacy and safety of the novel oral anticoagulant rivaroxaban for anticoagulation therapy in elderly patients(>80 years old)with persistent atrial fibrillation(PerAF)and type 2 diabetes mellitus.Methods From September 2014 to December 2018, 141 elderly patients with PerAF and type 2 diabetes were recruited from Tianjin Fifth Central Hospital. 118 patients completed the follow-up were included in this study and were randomly divided into two groups: rivaroxaban group(Group A, n=59)and warfarin group(Group B, n=59). The baseline data were collected, the CHA2DS2-VASc and HAS-BLED scores were calculated, the INR level was monitored, and the incidence of bleeding and embolism events were statistically compared.Results There were no significant differences between the two groups in the baseline clinical data of gender, age, CHA2DS2-VASc score, HAS-BLED score, body mass index, blood potassium, estimated glomerular filtration rate, uric acid, glycosylated hemoglobin(HbA1c)and echocardiographic parameters(all P>0.05). The difference between the two groups in the history of diabetes was statistically significant(P=0.016). During one year follow-up, the incidences of gingival bleeding, skin ecchymosis, hemoptysis, haematemesis, black stool, uremia, cerebral hemorrhage, cerebral embolism and peripheral arterial embolism were similar between the two groups. The whole incidence of hemorrhage in group A was 20.3%, and that in group B was 33.9%, without significant difference between the two groups(P=0.098). One case of fatal cerebral hemorrhage occurred in group B. There was no thromboembolism in both groups.Conclusion Rivaroxaban can be used for anticoagulation therapy in elderly patients with PerAF and type 2 diabetes mellitus,the safety is similar to Warfarin.

参考文献/References:

[1] Schnabel RB,Haeusler KG,Healey JS,et al.Searching for atrial fibrillation poststroke:a white paper of the AF-SCREEN international collaboration[J].Circulation,2019,140(22):1834-1850.DOI:10.1161/CIRCULATIONAHA.119.040267.
[2] Morrone D,Kroep S,Ricci F,et al.Mortality prediction of the CHA2DS2-VASc score,the HAS-BLED score,and their combination in anticoagulated patients with atrial fibrillation[J].J Clin Med,2020,9(12):3987.DOI:10.3390/jcm9123987.
[3] Alanazy MH,Muayqil T.Practice variations in the use of novel oral anticoagulants for nonvalvular atrial fibrillation-related stroke among stroke neurologists in saudi arabia[J].Neurol Res Int,2019,2019:5373250.DOI:10.1155/2019/5373250.
[4] Minematsu K,Ikeda T,Ogawa S,et al.Real-world outcomes of rivaroxaban treatment in patients with both nonvalvular atrial fibrillation and a history of ischemic stroke/transient ischemic attack[J].Cerebrovasc Dis,2019,48(1-2):53-60.DOI:10.1159/000502883.
[5] Fauchier L,Blin P,Sacher F,et al.Reduced dose of rivaroxaban and dabigatran vs.vitamin K antagonists in very elderly patients with atrial fibrillation in a nationwide cohort study[J].Europace,2020,22(2):205-215.DOI:10.1093/europace/euz285.
[6] Noseworthy PA,Yao X,Abraham NS,et al.Direct comparison of dabigatran,rivaroxaban,and apixaban for effectiveness and safety in nonvalvular atrial fibrillation[J].Chest,2016,150(6):1302-1312.DOI:10.1016/j.chest.2016.07.013.
[7] Maura G,Blotière PO,Bouillon K,et al.Comparison of the short-term risk of bleeding and arterial thromboembolic events in nonvalvular atrial fibrillation patients newly treated with dabigatran or rivaroxaban versus vitamin K antagonists:a French nationwide propensity-matched cohort study[J].Circulation,2015,132(13):1252-1260.DOI:10.1161/CIRCULATIONAHA.115.015710.
[8] Cen Z,Meng Q,Cui K.New oral anticoagulants for nonvalvular atrial fibrillation with stable coronary artery disease:a meta-analysis[J].Pacing Clin Electrophysiol,2020,43(11):1393-1400.DOI:10.1111/pace.14081.
[9] Sherwood MW,Nessel CC,Hellkamp AS,et al.Gastrointestinal bleeding in patients with atrial fibrillation treated with rivaroxaban or warfarin:ROCKET AF trial[J].J Am Coll Cardiol,2015,66(21):2271-2281.DOI:10.1016/j.jacc.2015.09.024.
[10] Spencer RJ,Amerena JV.Rivaroxaban in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation:clinical implications of the ROCKET AF trial and its subanalyses[J].Am J Cardiovasc Drugs,2015,15(6):395-401.DOI:10.1007/s40256-015-0127-2.
[11] Juo YY,Sanaiha Y,Benharash P.Left atrial appendage occlusion in research and in real-world practice[J].J Thorac Cardiovasc Surg,2018,156(3):1086-1087.DOI:10.1016/j.jtcvs.2018.05.025.
[12] Pacha HM,Hritani R,Alraies MC.Antithrombotic therapy after percutaneous left atrial appendage occlusion using the WATCHMAN device[J].Ochsner J,2018,18(3):193-194.DOI:10.31486/toj.18.0012.
[13] Yao X,Noseworthy PA.Left atrial appendage occlusion and surgical ablation for atrial fibrillation during cardiac surgery-reply[J].JAMA,2018,320(15):1602-1603.DOI:10.1001/jama.2018.11341.
[14] Bernier M,Lancrerot SL,Parassol N,et al.Therapeutic drug monitoring of direct oral anticoagulants may increase their benefit-risk ratio[J].J Cardiovasc Pharmacol,2020,76(4):472-477.DOI:10.1097/FJC.0000000000000870.
[15] Atar D,Berge E,Le Heuzey JY,et al.The association between patterns of atrial fibrillation,anticoagulation,and cardiovascular events[J].Europace,2020,22(2):195-204.DOI:10.1093/europace/euz292.
[16] Sakuma I,Uchiyama S,Atarashi H,et al.Clinical risk factors of stroke and major bleeding in patients with non-valvular atrial fibrillation under rivaroxaban:the EXPAND study sub-analysis[J].Heart Vessels,2019,34(11):1839-1851.DOI:10.1007/s00380-019-01425-x.
[17] Li TC,Wang HC,Li CI,et al.Establishment and validation of a prediction model for ischemic stroke risks in patients with type 2 diabetes[J].Diabetes Res Clin Pract,2018,138:220-228.DOI:10.1016/j.diabres.2018.01.034.
[18] Boriani G,Proietti M,Laroche C,et al.Changes to oral anticoagulant therapy and risk of death over a 3-year follow-up of a contemporary cohort of European patients with atrial fibrillation final report of the EUR observational research programme on atrial fibrillation(EORP-AF)pilot general registry[J].Int J Cardiol,2018,271:68-74.DOI:10.1016/j.ijcard.2018.05.034.
[19] Kim YH,Shim J,Tsai CT,et al.XANAP:a real-world,prospective,observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in Asia[J].J Arrhythm,2018,34(4):418-427.DOI:10.1002/joa3.12073.
[20] 梁珊珊,刘昊凌,高昕媛,等.2型糖尿病合并下肢动脉疾病患者血清FGF-23与骨钙素的关系研究[J].国际内分泌代谢杂志,2020,40(1):10-15.DOI:10.3760/cma.j.issn.1673-4157.2020.01.003.
[21] 陈建康,朱鹏立,严瑜,等.小剂量利伐沙班对预防2型糖尿病伴心房颤动高龄患者脑卒中的疗效分析[J].中国医科大学学报,2015,44(8):755-757.DOI:10.3969/j.issn.0258-4646.2015.08.021.

备注/Memo

备注/Memo:
通信作者:王肃,Email: wsrealm@126.com
更新日期/Last Update: 1900-01-01