Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, NJ, USA.
Ann Pharmacother. 2013 Jun;47(6):828-40. doi: 10.1345/aph.1R720. Epub 2013 May 14.
To determine the usefulness of coagulation assay monitoring for dabigatran etexilate in certain high-risk clinical situations.
Literature retrieval was accessed through MEDLINE (1948-February 2013), Web of Science (1980-February 2013), International Pharmaceutical Abstracts (1977-February 2013), and Google Scholar using the terms dabigatran, dabigatran etexilate, BIBR 1048, BIBR 953, direct thrombin inhibitor, therapeutic monitoring, and atrial fibrillation. In addition, abstracts presented at the 2011-2012 American Society of Hematology, American College of Cardiology, International Society of Thrombosis and Haemostasis, and European Society of Cardiology annual meetings were reviewed. A search of Clinicaltrials.gov was performed to identify relevant ongoing or completed research.
All English-language articles identified from the data sources were evaluated for inclusion. Priority was placed on all data derived from controlled clinical studies.
Of the 6 published Phase 3 studies, only the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial evaluated the safety and efficacy of dabigatran for the prevention of stroke in patients with nonvalvular atrial fibrillation. Post hoc analyses of the RE-LY trial have provided additional information in special situations. Several published reports highlight the potential for complications with dabigatran, the importance of determining the most optimal candidates, and the need for therapeutic monitoring. Activated partial thromboplastin time and thrombin time are effective qualitative assays for dabigatran. Ecarin clotting time and the dilute thrombin time (ie, Hemoclot direct thrombin inhibitor) assays are suitable for quantitative measurement.
The correlation between coagulation-based assays and clinical out comes among dabigatran-treated patients has not been definitively established. However, coagulation-based assays may be useful in the management of several clinical scenarios.
确定凝血分析监测在某些高危临床情况下对达比加群酯的应用价值。
通过 MEDLINE（1948 年-2013 年 2 月）、Web of Science（1980 年-2013 年 2 月）、国际药学文摘（1977 年-2013 年 2 月）和 Google Scholar 检索文献，使用达比加群、达比加群酯、BIBR 1048、BIBR 953、直接凝血酶抑制剂、治疗监测和心房颤动等术语。此外，还查阅了 2011-2012 年美国血液学会、美国心脏病学会、国际血栓与止血学会和欧洲心脏病学会年会的摘要。在 Clinicaltrials.gov 上进行了搜索，以确定相关的正在进行或已完成的研究。
从资料来源中评估所有识别出的英文文章，以确定是否纳入。所有数据均优先来自对照临床试验。
在已发表的 6 项 3 期研究中，只有 RE-LY（随机长期抗凝治疗评价）试验评估了达比加群酯预防非瓣膜性心房颤动患者中风的安全性和有效性。RE-LY 试验的事后分析提供了特殊情况下的额外信息。一些已发表的报告强调了达比加群的并发症风险，确定最佳候选者的重要性以及治疗监测的必要性。活化部分凝血活酶时间和凝血酶时间是达比加群酯的有效定性检测方法。蛇静脉酶凝结时间和稀释凝血酶时间（即，Hemoclot 直接凝血酶抑制剂）测定适用于定量测量。
尚未明确确定凝血检测与接受达比加群治疗的患者临床结果之间的相关性。然而，凝血检测可能对几种临床情况的管理有用。
