R&D Center of New Drugs, School of Pharmacy, Second Military Medical University, 325 Guo He Road, Shanghai, 200433, People's Republic of China.
Eur J Clin Pharmacol. 2010 Nov;66(11):1099-108. doi: 10.1007/s00228-010-0889-z. Epub 2010 Sep 2.
Rivaroxaban is a newly developed oral medicine that direct inhibits factor Xa for the prevention and treatment of thromboembolic disorders. The objective of this study was to compare the efficacy and safety of rivaroxaban versus enoxaparin, a medicine routinely used for thromboprophylaxis after total hip or knee arthroplasty.
We performed a meta-analysis of relevant randomized controlled trials (RCTs) identified in PubMed, Cochrane library, and Embase. The primary efficacy outcome for our meta-analysis was total venous thromboembolism (VTE) and all-cause mortality. The primary safety outcome was bleeding events, which were categorized as major, clinically relevant non-major, or minor events.
Eight RCTs, involving 15,586 patients, were included in our meta-analysis. Compared to enoxaparin, thromboprophylaxis with rivaroxaban was associated with significantly fewer VTE and all-cause mortality [9,244 patients, risk ratio (RR) 0.56, 95% confidence interval (CI) 0.39-0.80] cases and a similar incidence of bleeding cases (major bleeding events: 13,384 patients, RR 1.65, 95% CI 0.93-2.93; clinically relevant non-major bleeding events: 13,384 patients, RR 1.21, 95% CI 0.98-1.50; total bleeding events, 13,384 patients, RR 1.10, 95% CI 0.97-1.24). The total hip or knee arthroplasty subgroup analysis revealed consistent efficacy and safety findings.
Rivaroxaban was more effective than the recommended dose of enoxaparin and had a similar safety profile for thromboprophylaxis after hip and knee arthroplasty.
利伐沙班是一种新开发的口服药物,可直接抑制因子 Xa,用于预防和治疗血栓栓塞性疾病。本研究的目的是比较利伐沙班与依诺肝素(一种常规用于髋关节或膝关节置换术后血栓预防的药物)的疗效和安全性。
我们对 PubMed、Cochrane 图书馆和 Embase 中确定的相关随机对照试验(RCT)进行了荟萃分析。我们荟萃分析的主要疗效结局是总静脉血栓栓塞症(VTE)和全因死亡率。主要安全性结局是出血事件,分为主要、临床相关非主要或次要事件。
纳入我们荟萃分析的 8 项 RCT 共涉及 15586 例患者。与依诺肝素相比,利伐沙班预防血栓形成与 VTE 和全因死亡率显著降低相关[9024 例患者,风险比(RR)0.56,95%置信区间(CI)0.39-0.80],且出血事件发生率相似(主要出血事件:13384 例患者,RR 1.65,95%CI 0.93-2.93;临床相关非主要出血事件:13384 例患者,RR 1.21,95%CI 0.98-1.50;总出血事件:13384 例患者,RR 1.10,95%CI 0.97-1.24)。髋关节或膝关节置换术亚组分析显示出一致的疗效和安全性结果。
利伐沙班比推荐剂量的依诺肝素更有效,且髋关节和膝关节置换术后预防血栓形成的安全性相似。