目的:系统了解达比加群酯相关出血事件的发生情况，为临床安全用药提供参考。方法:提取2004年1月至2019年4月美国FDA不良事件报告系统（FAERS）中首要怀疑药物为达比加群酯的不良事件（AE）和出血事件报告，依据国际医学用语词典中药物不良反应术语集的首选系统器官分类（SOC）和首选术语（PT）对出血事件报告进行分类，并提取患者年龄、性别、用药剂量和AE发生情况。采用报告比值比（n ROR）法、比例报告比值比（n PRR）法和贝叶斯可信区间递进神经网络（BCPNN）法等3种方法，分别基于SOC和PT对达比加群酯相关出血事件信号进行检测，3种方法检测结果均为阳性则判断该信号为可疑出血事件信号。n 结果:共获得以达比加群酯为首要怀疑药物的AE报告56 501份，其中出血事件报告19 737份（34.93%）。19 737例患者中，男性9 687例（49.08%），女性9 790例（49.60%），性别不详者260例（1.32%）；年龄18~95岁，<75岁者2 742例（13.89%），≥75岁者15 051例（76.26%），年龄不详者1 944例（9.85%）；达比加群酯给药剂量为110 mg、1次/d者416例（2.11%），110 mg、2次/d者2 346例（11.89%），150 mg、1次/d者525例（2.66%），150 mg、2次/d者4 012例（20.33%），剂量不详者12 438例（63.02%）；发生严重出血事件者9 242例（46.83%），死亡3 260例（16.52%）。3种方法均检测出阳性信号的SOC为胃肠系统疾病（14 382例，72.87%）、中枢神经系统疾病（3 216例，16.29%）、肾脏及泌尿系统疾病（1 462例，7.41%）、皮肤及皮下组织疾病（576例，2.92%）和眼器官疾病（101例，0.51%），信号强度居前3位者为胃肠系统疾病、肾脏及泌尿系统疾病和中枢神经系统疾病。3种方法检测结果均为阳性的PT共32个，对应于胃肠系统疾病的阳性PT为12个，信号强度居前5位者依次为下消化道出血、消化道出血、上消化道出血、慢性消化道出血和黑便；对应于肾脏及泌尿系统疾病的阳性PT为2个，强度居前者为泌尿道出血；对应于中枢神经系统疾病的阳性PT为11个，信号强度居前5位者依次为颅内出血、颅内血肿、出血性卒中、硬膜下出血和硬脊膜外出血；对应于皮肤及皮下组织疾病的阳性PT为4个，信号强度居首位者为皮下出血；对应于眼器官疾病的阳性PT为2个，强度居前者为结膜出血。结论:出血事件是达比加群酯较严重的AE，消化道出血多见。≥75岁的患者出血风险更高，应引起临床重视。“,”Objective:To systematically understand the occurrence of dabigatran etexilate-related bleeding events, and provide reference for clinical safe drug use.Methods:Reports on adverse event (AE) and bleeding event, in which dabigatran etexilate was considered as the first suspected drug, in the US Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to April 2019 were extracted. According to the preferred system organ class (SOC) and preferred term (PT) from terminology of adverse drug reactions in Medical Dictionary for Regulatory Activities, the bleeding event reports were classified, and the patient′s age, gender, drug dosage and AE occurrence were extracted. Based on SOC and PT respectively, the signals of dabigatran etexilate-related hemorrhage were detected using 3 methods including reporting odds ratio (n ROR), proportional reporting ratio (n PRR), and Bayesian confidence propagation neural network (BCPNN). If the results were all positive using the 3 methods, it would be considered as the suspected AE signal.n Results:A total of 56 501 AE reports with dabigatran etexilate as the primary suspected drug were collected, in which 19 737 (34.93%) reports were about bleeding events. Among the 19 737 patients, 9 687 (49.08%) were male, 9 790 (49.60%) were female, and 260 (1.32%) were with unknown gender; their ages ranged from 18 to 95 years, 2 742 (13.89%) patients were <75 years old, 15 051 (76.26%) were ≥75 years old, and 1 944 (9.85%) were with unknown age; the dose of dabigatran etexilate was 110 mg once daily in 416 patients (2.11%), 110 mg twice daily in 2 346 patients (11.89%), 150 mg once daily in 525 patients (2.66%), 150 mg twice daily in 402 patients (20.33%), and unknown in 12 438 patients (63.02%); 9 242 patients (46.83%) developed serious bleeding events, and 3 260 patients (16.52%) died. The SOCs with positive signals detected using the 3 methods were gastrointestinal disorders(14 382 cases, 72.87%), central nervous disorders (3 216 cases,16.29%), renal and urinary disorders (7.41%, 1 462 cases), skin and subcutaneous tissue disorders (2.92%, 576 cases), and eye disorders (0.51%, 101 cases). The top 3 SOCs with higher signal intensities were gastrointestinal disorders, renal and urinary disorders, and central nervous disorders. A total of 32 PTs with positive signals were detected using the 3 methods. Of them, 12 PTs were positive in gastrointestinal disorders, and the top 5 PTs with higher signal intensities were lower gastrointestinal bleeding, gastrointestinal bleeding, upper gastrointestinal bleeding, chronic gastrointestinal bleeding, and melena; 2 PTs were positive in renal and urinary disorders, in which the urinary tract hemorrhage was with higher intensity; 11 PTs were positive in central nervous disorders, and the top 5 PTs with higher signal intensities were intracranial hemorrhage, intracranial hematoma, hemorrhagic stroke, subdural hemorrhage, and epidural hemorrhage; 4 PTs were positive in skin and subcutaneous tissue disorders, and the signal intensity of subcutaneous hemorrhage ranked the first; 2 PTs were positive in eye disorders, in which the conjunctival hemorrhage was with higher intensity.Conclusions:Bleeding is more severe in dabigatran etexilate-related AEs, and gastrointestinal bleeding is more common. Patients with age ≥75 years have a higher risk of bleeding, which should be paid attention to in clinic.