Beliavskaia O O, Vavilova T V
Angiol Sosud Khir. 2014;20(4):37-41.
The problem of prevention and treatment of thromboembolic complications has a significant place in clinical practice for many years. The gold-standard agents in long-term protection from embologenic strokes, secondary prevention of venous thromboses and embolisms still remain vitamin K antagonists (in Russia - warfarin). However, despite high efficacy, administration of warfarin is fraught with dangers and associated with a series of inconveniences. A direct thrombin inhibitor, dabigatran etexilate (hereinafter referred to as dabigatran) was approved in the Russian Federation for prevention of thromboembolic complications in orthopaedic practice (2009), for prevention of ischaemic embologenic stroke in atrial fibrillation (2011) and for treatment of recurrent thrombosis of deep veins and pulmonary artery thromboembolism (2014). A characteristic feature of a therapeutic agent possessing an anticoagulation effect is correlation between intensity of hypocoagulation and haemorrhage. The effect of dabigatran on the laboratory parameters of haemostasis has been studied insufficiently, with no practical guidelines on assessing these alterations for prediction of the risk for haemorrhagic and thromboembolic complications. The present study included a total of 65 patients with non-valvular aetiology atrial fibrillation, taking dabigatran during from 6 to 18 months. All patients underwent laboratory assessment of the coagulation level and measuring blood coagulation activation markers in dynamics 10-14 days, 1, 6, 12 and 18 months after taking the agent. Thromboembolic and haemorrhagic risks were also assessed. It was revealed that administration of dabigatran leads to alterations in the main parameters of coagulogram. Determination of prothrombin (in % according to Quick's method) and activated partial thromboplastin time may be used for qualitative assessment of hypocoagulation. During the follow up period no statistically significant changes in the coagulation activation markers level were observed.
多年来，血栓栓塞性并发症的防治问题在临床实践中占据重要地位。长期预防栓塞性中风、静脉血栓形成和栓塞的二级预防的金标准药物仍然是维生素K拮抗剂（在俄罗斯为华法林）。然而，尽管华法林疗效高，但使用华法林充满危险且伴有一系列不便之处。直接凝血酶抑制剂达比加群酯（以下简称达比加群）于2009年在俄罗斯联邦被批准用于骨科实践中预防血栓栓塞性并发症，2011年用于预防房颤中的缺血性栓塞性中风，2014年用于治疗深静脉复发性血栓形成和肺动脉血栓栓塞。具有抗凝作用的治疗药物的一个特征是低凝强度与出血之间的相关性。达比加群对止血实验室参数的影响研究不足，尚无评估这些改变以预测出血和血栓栓塞性并发症风险的实用指南。本研究共纳入65例非瓣膜性病因房颤患者，服用达比加群6至18个月。所有患者在服用药物后10 - 14天、1个月、6个月、12个月和18个月动态进行凝血水平的实验室评估并测量凝血激活标志物。还评估了血栓栓塞和出血风险。结果显示，服用达比加群会导致凝血图主要参数发生改变。凝血酶原测定（根据Quick法以百分比表示）和活化部分凝血活酶时间可用于低凝的定性评估。在随访期间，未观察到凝血激活标志物水平有统计学上的显著变化。
