意大利佩鲁贾大学Giancarlo Agnelli课题组近日取得一项新成果。经过不懈努力，他们探讨了阿哌沙班治疗癌症相关的静脉血栓栓塞的疗效。该研究于2020年3月29日发表于《新英格兰医学杂志》上。

最近的指南提议可用口服依多沙班或利伐沙班治疗癌症患者的静脉血栓栓塞。然而，这些口服剂却增加了相关的出血风险。

在这项多国、随机、研究者发起、开放标签、非劣效性、盲中心结局的试验中，研究组招募有症状或偶发的急性近端深静脉血栓形成或肺栓塞的癌症患者，将其随机分组，其中576例口服阿哌沙班治疗，579例接受皮下达肝素进行治疗。两组均连续治疗6个月。

阿哌沙班组中有32例发生复发性静脉血栓栓塞（5.6%），达肝素组中有46例（7.9%），风险比为0.63。阿哌沙班组中有22例患者（3.8%）发生大出血，达肝素组中有23例（4.0%），风险比为0.82。

综上，口服阿哌沙班在治疗癌症相关的静脉血栓栓塞方面不逊于皮下达肝素，且不会增加大出血的风险。

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