德國殷格翰2019年9月5日 /美通社/ -- 勃林格殷格翰于近日公布了Re-Spect CVT®研究的初步分析結(jié)果，這是首個探索性、前瞻性、隨機對照的NOAC研究，研究對象為腦靜脈或靜脈竇中有血塊的患者。該試驗旨在研究泰畢全®（達比加群酯）和劑量調(diào)節(jié)后的華法林在CVT患者中的安全性和療效。
此項研究結(jié)果為輕中度CVT患者的抗凝治療提供了依據(jù)。在研究中，兩個治療組均無復發(fā)性靜脈血栓栓塞（VTE）事件的發(fā)生。1試驗還發(fā)現(xiàn)患者的出血率較低，華法林組有兩名患者（3.3%）、達比加群組有一名患者（1.7%）出現(xiàn)嚴重出血。在此次研究中，兩個治療組均未出現(xiàn)死亡事件。[1]
“CVT全稱為腦靜脈血栓，主要影響年輕患者和女性，可導致死亡和殘疾。CVT急性期存活的患者可能會出現(xiàn)復發(fā)性靜脈血栓。為了防止這類情況的發(fā)生，通常的臨床做法是給患者處方維生素K拮抗劑（VKAs，如華法林）。VKAs在安全性、劑量、可逆性和患者偏好方面均存在局限性?！逼咸蜒览锼贡臼ガ旣悂嗎t(yī)院神經(jīng)科學和心理健康科主任、RE-SPECT CVT指導委員會主席Jose M. Ferro教授說道?！癛E-SPECT CVT是迄今為止在CVT患者中進行的最大規(guī)模的試驗，涵蓋了120名患者。試驗表明，在使用達比加群抗凝治療6個月后，輕至中度CVT患者的VTE復發(fā)風險較低，且發(fā)生嚴重或臨床相關出血事件的概率極低?！?/p>
該試驗也表明了勃林格殷格翰致力于擴展血栓治療領域科學知識的決心。此外，試驗還幫助我們進一步了解了達比加群的安全性，達比加群的安全性已記錄在廣泛的RE-VOLUTION®試驗和登記研究項目中。[2]-[24]
References
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[19] Diener HC et al. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med 2019; 380:1906-1917.
[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.
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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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