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达比加群酯用于二级预防中风:106例患者的临床经验。

Dabigatran in secondary stroke prevention: clinical experience with 106 patients.

作者信息

DeFelipe-Mimbrera Alicia, Alonso Cánovas Araceli, Guillán Marta, Matute Consuelo, Sainz de la Maza Susana, Cruz Antonio, Vera Rocío, Masjuan Jaime

机构信息

Stroke Unit, Neurology Department, IRYCIS, University Hospital Ramón y Cajal, Carretera de Colmenar Viejo km 9,100, 28034 Madrid, Spain.

出版信息

Biomed Res Int. 2014;2014:567026. doi: 10.1155/2014/567026. Epub 2014 Jul 15.

DOI:10.1155/2014/567026
PMID:25133166
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4123474/
Abstract

INTRODUCTION

Our aim was to analyze our clinical experience with dabigatran etexilate in secondary stroke prevention.

METHODS

We retrospectively included patients starting dabigatran etexilate for secondary stroke prevention from March 2010 to December 2012. Efficacy and safety variables were registered.

RESULTS

106 patients were included, median follow-up of 12 months (range 1-31). Fifty-six females (52.8%), mean age 76.4 (range 50-95, SD 9.8), median CHADS2 4 (range 2-6), CHA2DS2-VASc 5 (range 2-9), and HAS-BLED 2 (range 1-5). Indication for dabigatran etexilate was ischemic stroke in 101 patients and acute cerebral hemorrhage (CH) due to warfarin in 5 (4.7%). Dabigatran etexilate 110 mg bid was prescribed in 71 cases (67%) and 150 mg bid was prescribed in the remaining. Seventeen patients (16%) suffered 20 complications during follow-up. Ischemic complications (10) were 6 transient ischemic attacks (TIA), 3 ischemic strokes, and 1 acute coronary syndrome. Hemorrhagic complications (10) were CH (1), gastrointestinal bleeding (6), mild hematuria (2), and mild metrorrhagia (1), leading to dabigatran etexilate discontinuation in 3 patients. Patients with previous CH remained uneventful. Three patients died (pneumonia, congestive heart failure, and acute cholecystitis) and 9 were lost during follow-up.

CONCLUSIONS

Dabigatran etexilate was safe and effective in secondary stroke prevention in clinical practice, including a small number of patients with previous history of CH.

摘要

引言

我们的目的是分析达比加群酯在二级预防中风方面的临床经验。

方法

我们回顾性纳入了2010年3月至2012年12月开始使用达比加群酯进行二级预防中风的患者。记录疗效和安全变量。

结果

纳入106例患者,中位随访时间为12个月(范围1 - 31个月)。56名女性(52.8%),平均年龄76.4岁(范围50 - 95岁,标准差9.8),CHADS2中位数为4(范围2 - 6),CHA2DS2 - VASc为5(范围2 - 9),HAS - BLED为2(范围1 - 5)。达比加群酯的适应症为101例缺血性中风患者和5例(4.7%)因华法林导致的急性脑出血(CH)患者。71例(67%)患者服用达比加群酯110mg bid,其余患者服用150mg bid。17例患者(16%)在随访期间出现20例并发症。缺血性并发症(10例)包括6例短暂性脑缺血发作(TIA)、3例缺血性中风和1例急性冠状动脉综合征。出血性并发症(10例)包括CH(1例)、胃肠道出血(6例)、轻度血尿(2例)和轻度子宫出血(1例),导致3例患者停用达比加群酯。既往有CH的患者病情平稳。3例患者死亡(肺炎、充血性心力衰竭和急性胆囊炎),9例患者在随访期间失访。

结论

在临床实践中,达比加群酯在二级预防中风方面是安全有效的,包括少数既往有CH病史的患者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fa1/4123474/823b1f48a07c/BMRI2014-567026.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fa1/4123474/823b1f48a07c/BMRI2014-567026.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fa1/4123474/823b1f48a07c/BMRI2014-567026.001.jpg

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Evaluation of dabigatran bleeding adverse reaction reports in the FDA adverse event reporting system during the first year of approval.达比加群获批第一年期间在FDA不良事件报告系统中对其出血不良反应报告的评估。
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