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利伐沙班用于瑞士非选择性骨科创伤手术后的血栓预防

Rivaroxaban for Thromboprophylaxis After Nonelective Orthopedic Trauma Surgery in Switzerland.

作者信息

Hoffmeyer Pierre, Simmen Hanspeter, Jakob Marcel, Sommer Christoph, Platz Andreas, Ilchmann Thomas, Grossen Erik, Ryf Christian, Christofilopoulos Panayiotis, Schueler Michael, Lassen Michael Rud, Rimle Markus, Gasser Urs E

出版信息

Orthopedics. 2017 Mar 1;40(2):109-116. doi: 10.3928/01477447-20161116-05. Epub 2016 Nov 23.

Abstract

This study investigated the effectiveness and the outcomes of rivaroxaban vs the standard of care for venous thromboembolic prophylaxis in patients undergoing fracture-related surgery. A total of 413 patients undergoing fracture-related surgery from 9 Swiss orthopedic and trauma centers were enrolled. The authors selected the type of venous thromboembolic prophylaxis according to standardized medical practice at the participating centers before the inclusion of patients: 208 patients received rivaroxaban and 205 received the standard of care. Data on symptomatic thromboembolic and bleeding events, surgery-related complications, death, adverse events, time to mobilization, and hospital discharge were collected. Symptomatic thromboembolic events were reported in 1 patient (0.5%) and 2 patients (1.0%) and treatment-emergent major bleeding events were reported in 1 patient (0.5%) and 2 patients (1.0%) receiving rivaroxaban and the standard of care, respectively. The durations of hospital stay and venous thromboembolic prophylaxis were similar in the 2 groups. In both groups, adverse events related to venous thromboembolic prophylaxis were reported in 12 patients. The proportion of patients with minor and major fracture surgery was 74.3% and 25.7%, respectively. In patients undergoing minor fracture surgery receiving rivaroxaban (n=167) and the standard of care (n=140), no symptomatic thromboembolic events and no major bleeding events were reported. Outcomes of this study indicate that rivaroxaban might be an appropriate oral alternative for venous thromboembolic prophylaxis in routine medical care after fracture-related major and minor surgery. Reported results were comparable to those from other large-scale, noninterventional and randomized controlled studies. [Orthopedics. 2017; 40(2):109-116.].

摘要

本研究调查了利伐沙班与骨折相关手术患者静脉血栓栓塞预防的标准治疗方法相比的有效性和结果。共有来自9个瑞士骨科和创伤中心的413例接受骨折相关手术的患者入组。作者在纳入患者之前,根据参与中心的标准化医疗实践选择静脉血栓栓塞预防类型:208例患者接受利伐沙班治疗,205例患者接受标准治疗。收集了有关症状性血栓栓塞和出血事件、手术相关并发症、死亡、不良事件、活动时间和出院时间的数据。接受利伐沙班和标准治疗的患者中,分别有1例(0.5%)和2例(1.0%)报告了症状性血栓栓塞事件,1例(0.5%)和2例(1.0%)报告了治疗中出现的严重出血事件。两组患者的住院时间和静脉血栓栓塞预防时间相似。两组均有12例患者报告了与静脉血栓栓塞预防相关的不良事件。接受小骨折手术和大骨折手术的患者比例分别为74.3%和25.7%。在接受利伐沙班治疗的小骨折手术患者(n = 167)和接受标准治疗的患者(n = 140)中,未报告症状性血栓栓塞事件和严重出血事件。本研究结果表明,利伐沙班可能是骨折相关大手术和小手术后常规医疗中静脉血栓栓塞预防的一种合适的口服替代药物。报告的结果与其他大规模、非干预性和随机对照研究的结果相当。[《骨科》。2017;40(2):109 - 116。]

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