阿哌沙班治療癌症相關靜脈血栓栓塞的療效不遜於皮下達肝素
作者：
小柯機器人發布時間：2020/3/30 13:05:27
義大利佩魯賈大學Giancarlo Agnelli課題組近日取得一項新成果。經過不懈努力，他們探討了阿哌沙班治療癌症相關的靜脈血栓栓塞的療效。該研究於2020年3月29日發表於《新英格蘭醫學雜誌》上。
最近的指南提議可用口服依多沙班或利伐沙班治療癌症患者的靜脈血栓栓塞。然而，這些口服劑卻增加了相關的出血風險。
在這項多國、隨機、研究者發起、開放標籤、非劣效性、盲中心結局的試驗中，研究組招募有症狀或偶發的急性近端深靜脈血栓形成或肺栓塞的癌症患者，將其隨機分組，其中576例口服阿哌沙班治療，579例接受皮下達肝素進行治療。兩組均連續治療6個月。
阿哌沙班組中有32例發生復發性靜脈血栓栓塞（5.6%），達肝素組中有46例（7.9%），風險比為0.63。阿哌沙班組中有22例患者（3.8%）發生大出血，達肝素組中有23例（4.0%），風險比為0.82。
綜上，口服阿哌沙班在治療癌症相關的靜脈血栓栓塞方面不遜於皮下達肝素，且不會增加大出血的風險。
附：英文原文
Title: Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer | NEJM
Author: Giancarlo Agnelli, M.D.,, Cecilia Becattini, M.D.,, Guy Meyer, M.D.,, Andres Muoz, M.D.,, Menno V. Huisman, M.D.,, Jean M. Connors, M.D.,, Alexander Cohen, M.D.,, Rupert Bauersachs, M.D.,, Benjamin Brenner, M.D.,, Adam Torbicki, M.D.,, Maria R. Sueiro, M.D.,, Catherine Lambert, M.D.,, Gualberto Gussoni, M.D.,, Mauro Campanini, M.D.,, Andrea Fontanella, M.D.,, Giorgio Vescovo, M.D.,, and Melina Verso, M.D.
Issue&Volume: 2020-03-29
Abstract: Abstract
Background
Recent guidelines recommend consideration of the use of oral edoxaban or rivaroxaban for the treatment of venous thromboembolism in patients with cancer. However, the benefit of these oral agents is limited by the increased risk of bleeding associated with their use.
Methods
This was a multinational, randomized, investigator-initiated, open-label, noninferiority trial with blinded central outcome adjudication. We randomly assigned consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive oral apixaban (at a dose of 10 mg twice daily for the first 7 days, followed by 5 mg twice daily) or subcutaneous dalteparin (at a dose of 200 IU per kilogram of body weight once daily for the first month, followed by 150 IU per kilogram once daily). The treatments were administered for 6 months. The primary outcome was objectively confirmed recurrent venous thromboembolism during the trial period. The principal safety outcome was major bleeding.
Results
Recurrent venous thromboembolism occurred in 32 of 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% confidence interval [CI], 0.37 to 1.07; P<0.001 for noninferiority). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P=0.60).
Conclusions
Oral apixaban was noninferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism without an increased risk of major bleeding.
DOI: 10.1056/NEJMoa1915103
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1915103