并用胺碘酮对达比加群酯治疗心房颤动患者出血风险影响的回顾性队列研究  

A retrospective cohort study on the effect of concomitant amiodarone on bleeding risk in atrial fibrillation patients with dabigatran etexilate treatment

作　　者：魏安华[1] 王璐[1] 曾露[1] 李为[1] 贡雪芃[1] 刘东[1] Wei Anhua;Wang Lu;Zeng Lu;Li Wei;Gong Xuepeng;Liu Dong(Department of Pharmacy,Tongji Hospital,Tongji Medical College,Huazhong University of Science&Technology,Hubei Province,Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,武汉430033

出　　处：《药物不良反应杂志》2025年第1期6-10,共5页Adverse Drug Reactions Journal

基　　金：中国研究型医院学会临床重点药品的使用监测和评价研究专项(Y2023FH-YWPJ03-203)。

摘　　要：目的探讨达比加群酯治疗的心房颤动(房颤)患者合并胺碘酮治疗后对出血风险的影响。方法本研究是一项回顾性队列研究。收集2022年7月1日至2023年6月30日在华中科技大学同济医学院附属同济医院服用达比加群酯的房颤住院患者的临床资料,将患者按照是否口服胺碘酮分为合并胺碘酮组和未合并胺碘酮组,选择患者性别、年龄、主要基础疾病和基础疾病种数、基线肝肾功能、达比加群酯用法用量等参数对合并胺碘酮组和未合并胺碘酮组患者按1∶1的比例进行倾向性评分匹配(PSM),比较2组患者出血事件的发生率。结果共纳入878例患者,男性568例(64.7%),女性310例(35.3%),年龄67(59,74)岁;合并胺碘酮组患者252例(28.7%),未合并胺碘酮组患者626例(71.3%)。随访3个月,合并胺碘酮组和未合并胺碘酮组患者出血事件发生率分别为19.0%(48/252)和21.2%(133/626);PSM后出血事件发生率分别为19.0%(48/252)和16.7%(40/239),差异均无统计学意义(均P>0.05)。2组患者的出血类型均以轻微出血事件为主[62.5%(30/48)比67.5%(27/40)],出血部位以牙龈、皮肤和鼻较为常见;2组患者出血类型及各出血部位出血发生率的差异也均无统计学意义(均P>0.05)。结论与达比加群酯治疗的房颤未合并胺碘酮的患者相比,合并口服胺碘酮患者短期内出血风险未显著增加。达比加群酯治疗期间的出血事件主要为轻微出血,但仍需要临床警惕。Objective To explore the effect of concomitant amiodarone on the bleeding risk in atrial fibrillation patients treated with dabigatran etexilate.Methods This study was a retrospective cohort study.The clinical data of hospitalized patients with atrial fibrillation who took dabigatran etexilate in Tongji Hospital,Tongji Medical College,Huazhong University of Science&Technology from July 1,2022 to June 30,2023 were collected.Patients were divided into concomitant amiodarone group and non concomitant amiodarone group according to whether they were treated with oral amiodarone.Propensity score matching(PSM)was performed at a 1∶1 ratio in patients between the 2 groups according to patient's gender,age,main basic diseases and the number of basic diseases,baseline liver and kidney function,dosage of dabigatran etexilate,etc.The incidence of bleeding events was compared between the 2 groups.Results A total of 878 patients were included in the study,including 568 males(64.7%)and 310 females(35.3%),with a age of 67(59,74)years.There were 252 patients(28.7%)in the concomitant amiodarone group and 626 patients(71.3%)in the non concomitant amiodarone group.Within 3 months of follow-up,the incidence of bleeding events in patients of concomitant and non concomitant amiodarone groups were 19.0%(48/252)and 21.2%(133/626),respectively,which were 19.0%(48/252)and 16.7%(40/239)after PSM,respectively,with no significant difference(all P>0.05).The main type of bleeding in patients of both groups was mild bleeding events[62.5%(30/48)vs.67.5%(27/40)],and bleeding was more common in the gums,skin,and nose.There was no statistically significant difference in incidence of the bleeding types and bleeding sites of patients between the 2 groups(all P>0.05).Conclusions Compared with patients with atrial fibrillation when treated with dabigatran etexilate and without concomitant amiodarone,the bleeding risk of patients with amiodarone did not significantly increased in the short term.The bleeding events during treatment of dabigatran etexilat

关 键 词：达比加群 胺碘酮 药物相互作用 心房颤动 出血 

分 类 号：R541.75[医药卫生—心血管疾病]