抗凝门诊非瓣膜性心房颤动患者口服抗凝药物出血发生情况分析

Analysis of Bleeding in Patients With Non-valvular Atrial Fibrillationon Treated With Oral Anticoagulants in an Anticoagulantion Outpatient Clinic

目的:分析非瓣膜性心房颤动(NVAF)患者服用华法林和新型口服抗凝药物(NOACs)的出血发生情况.方法:纳入2014年11月至2019年1月中国医学科学院阜外医院抗凝门诊接受口服抗凝药(OAC)治疗的682例NVAF患者,对其3102次就诊时报告的出血及其他安全性事件发生情况进行回顾性分析.服用华法林、达比加群酯、利伐沙班的患者分别有551例(80.79%)、83例(12.17%)和48例(7.04%).出血类别包括小出血、临床相关非大出血(CRNMB)和大出血.同时分析华法林抗凝患者中国际标准化比值(INR)在不同范围内的百分比以及INR危急值(>4.5)的发生率和原因等.结果:682例患者共发生174例次(25.5%)出血事件,其中16例(2.3%)患者发生CRNMB,10例(1.5%)患者发生大出血.小出血148例次,占就诊次数的4.8%.接受华法林、达比加群酯、利伐沙班治疗的患者中出血发生率无明显差异.在使用华法林的患者共2869次就诊中,INR危急值共出现27例(0.94%),其中10例(37.0%)与药物相互作用有关,6例(22.2%)为华法林快代谢型.华法林抗凝期间发生小出血的患者INR多在目标范围内.结论:在抗凝门诊接受华法林和NOACs治疗的NVAF患者中,小出血和CRNMB事件发生率较高.分析华法林抗凝治疗期间出现INR危急值的原因以及出血事件与INR的相关性能够为临床提供预见性的实践指导.

Objectives: To analysis the bleeding complication in non-valvular atrial fibrillationon (NVAF) patients on warfarin and new oral anticoagulants (NOACs). Methods: This retrospective analysis was conducted based data from 3 102 visits of 682 NVAF patients on oral anticoagulants in the anticoagulation outpatient clinic from November 2014 to January 2019. Descriptive analysis was conducted for safety events such as bleeding and other safety events. Warfarin, dabigatran and rivaroxaban were used in 551 (80.79%), 83 (12.17%) and 48 (7.04%) patients respectively. The categories of bleeding include minor bleeding, clinically related non-major bleeding (CRNMB) and major bleeding. At the same time, warfarin time in the therapeutic range (TTR) and the incidence and causes of international normalized ratio (INR) and critical value (>4.5) were analyzed. Results: A total of 174 (25.5%) bleeding events occurred out of 682 patients, among which 16 (2.3%) patients suffered CRNMB and 10 (1.5%) patients suffered major bleeding. There were 148 cases of minor bleeding, accounting for 4.8% of the total number of visits. There was no difference in the incidence of bleeding among warfarin, dabigatran and rivaroxaban. Among the 2 869 visits of patients on warfarin, critical values of INR occurred 27 (0.94%) times, among which 10 (37.0%) cases were related to drug interactions, and 6 (22.2%) cases were due to warfarin extensive metabolizers. Patients with minor bleeding were more likely to have INR within the target range. Conclusions: Warfarin and NOACs use is related with more minor bleeding and CRNMB in the anticoagulation outpatient clinic. The analysis results of the causes of INR critical value and the correlation between bleeding and INR values can provide foreseeable practical guidance on daily anticoagulant practice for NVAF patients.