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(jī)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(yàn)旨在研究泰畢全®（達(dá)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(xiàng)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(fù)發(fā)性靜脈血栓栓塞（VTE）事件的發(fā)生。1試驗(yàn)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(dá)比加群組有一名患者（1.7%）出現(xiàn)嚴(yán)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(dǎo)致死亡和殘疾。CVT急性期存活的患者可能會出現(xiàn)復(fù)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。”葡萄牙里斯本圣瑪麗亞醫(yī)院神經(jīng)科學(xué)和心理健康科主任、RE-SPECT CVT指導(dǎo)委員會主席Jose M. Ferro教授說道。“RE-SPECT CVT是迄今為止在CVT患者中進(jìn)行的最大規(guī)模的試驗(yàn)，涵蓋了120名患者。試驗(yàn)表明，在使用達(dá)比加群抗凝治療6個月后，輕至中度CVT患者的VTE復(fù)發(fā)風(fēng)險(xiǎn)較低，且發(fā)生嚴(yán)重或臨床相關(guān)出血事件的概率極低。”
該試驗(yàn)也表明了勃林格殷格翰致力于擴(kuò)展血栓治療領(lǐng)域科學(xué)知識的決心。此外，試驗(yàn)還幫助我們進(jìn)一步了解了達(dá)比加群的安全性，達(dá)比加群的安全性已記錄在廣泛的RE-VOLUTION®試驗(yàn)和登記研究項(xiàng)目中。[2]-[24]
References
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