德国殷格翰2019年9月5日 /美通社/ -- 勃林格殷格翰于近日公布了Re-Spect CVT®研究的初步分析结果，这是首个探索性、前瞻性、随机对照的NOAC研究，研究对象为脑静脉或静脉窦中有血块的患者。该试验旨在研究泰毕全®（达比加群酯）和剂量调节后的华法林在CVT患者中的安全性和疗效。
此项研究结果为轻中度CVT患者的抗凝治疗提供了依据。在研究中，两个治疗组均无复发性静脉血栓栓塞（VTE）事件的发生。1试验还发现患者的出血率较低，华法林组有两名患者（3.3%）、达比加群组有一名患者（1.7%）出现严重出血。在此次研究中，两个治疗组均未出现死亡事件。[1]
“CVT全称为脑静脉血栓，主要影响年轻患者和女性，可导致死亡和残疾。CVT急性期存活的患者可能会出现复发性静脉血栓。为了防止这类情况的发生，通常的临床做法是给患者处方维生素K拮抗剂（VKAs，如华法林）。VKAs在安全性、剂量、可逆性和患者偏好方面均存在局限性。”葡萄牙里斯本圣玛丽亚医院神经科学和心理健康科主任、RE-SPECT CVT指导委员会主席Jose M. Ferro教授说道。“RE-SPECT CVT是迄今为止在CVT患者中进行的最大规模的试验，涵盖了120名患者。试验表明，在使用达比加群抗凝治疗6个月后，轻至中度CVT患者的VTE复发风险较低，且发生严重或临床相关出血事件的概率极低。”
该试验也表明了勃林格殷格翰致力于扩展血栓治疗领域科学知识的决心。此外，试验还帮助我们进一步了解了达比加群的安全性，达比加群的安全性已记录在广泛的RE-VOLUTION®试验和登记研究项目中。[2]-[24]
References
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[20] Ferro JM. et al. Randomized evaluation of the safety and efficacy of dabigatran etexilate versus dose adjusted warfarin in patients with cerebral venous thrombosis (RE-SPECT CVT). Presented on Tuesday 10 May at the 2nd European Stroke Organisation Conference 2016, Barcelona, Spain.
[21] Ageno W et al. RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate. Thromb Haemost. 2017;117:415–21
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[23] Huisman MV et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation.
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