Du Wei, Zhao Chunhong, Wang Jingjie, Liu Jianqing, Shen Binghua, Zheng Yanping
Department of Spine Surgery, Yantaishan Hospital, Yantai, 264000, China.
Department of Hematology, Yantaishan Hospital, Yantai, 264000, China.
J Orthop Surg Res. 2015 May 23;10:78. doi: 10.1186/s13018-015-0223-7.
The aim of this study was to evaluate the effectiveness and safety of rivaroxaban for preventing venous thromboembolism (VTE) after lumbar spine surgery.
In this randomized, controlled study, 665 patients who underwent lumbar surgery were randomly assigned to receive either rivaroxaban or parnaparin. Rivaroxaban and parnaparin were used for preventing postoperative venous thrombosis. The occurrence of postoperative efficacy endpoint events (venous thrombosis) and safety endpoint events (hemorrhage) was compared for each group.
Efficacy endpoint results: in the rivaroxaban group, there were 6 thrombotic events (1.7%), 2 cases with severe VTE (0.6%), and 3 cases with symptomatic VTE (0.9%). In the parnaparin group, there were 10 thrombotic events (3.1%), 4 cases with severe VTE (1.2%), and 6 cases with symptomatic VTE (1.9%). Safety endpoint results: in the rivaroxaban group, there were 21 cases with bleeding events (6.2%), 2 cases with severe bleeding (0.6%), and 19 cases with non-severe bleeding (5.6%). In the parnaparin group, there were 21 bleeding events (6.2%), 1 case with severe bleeding (0.3%), and 16 cases with non-severe bleeding (4.9%). The incidences of thromboembolic events, including severe and symptomatic VTE, were not significantly different between the two groups (P > 0.05). Bleeding event rates, including severe and non-severe bleeding, were also not significantly different.
Rivaroxaban proved to be equally effective as parnaparin for anticoagulation therapy, with both drugs exhibiting a similar prevention effect against postoperative VTE after lumbar spine surgery, without increasing the risk of postoperative bleeding.
本研究旨在评估利伐沙班预防腰椎手术后静脉血栓栓塞(VTE)的有效性和安全性。
在这项随机对照研究中,665例行腰椎手术的患者被随机分配接受利伐沙班或帕肝素治疗。利伐沙班和帕肝素用于预防术后静脉血栓形成。比较每组术后疗效终点事件(静脉血栓形成)和安全性终点事件(出血)的发生情况。
疗效终点结果:利伐沙班组有6例血栓事件(1.7%),2例严重VTE(0.6%),3例有症状VTE(0.9%)。帕肝素组有10例血栓事件(3.1%),4例严重VTE(1.2%),6例有症状VTE(1.9%)。安全性终点结果:利伐沙班组有21例出血事件(6.2%),2例严重出血(0.6%),19例非严重出血(5.6%)。帕肝素组有21例出血事件(6.2%),1例严重出血(0.3%),16例非严重出血(4.9%)。两组间包括严重和有症状VTE在内的血栓栓塞事件发生率无显著差异(P>0.05)。包括严重和非严重出血在内的出血事件发生率也无显著差异。
利伐沙班在抗凝治疗方面与帕肝素同样有效,两种药物对腰椎手术后的术后VTE均具有相似的预防效果,且不增加术后出血风险。