Department of Pharmacy, the Military General Hospital of Beijing PLA, Beijing 100700, China.
Chin Med J (Engl). 2012 Jul;125(13):2339-45.
Enoxaparin is routinely used for prevention of venous thromboembolism (VTE) after total hip or knee arthroplasty. The purpose of this study was to compare the efficacy and safety of apixaban, a newly oral direct inhibitor of factor Xa versus enoxaparin.
We performed a meta-analysis of relevant randomized-controlled trials (RCTs) identified in PubMed, Cochrane Library, Embase China Biological Medical Literature database, Countries Journal full-text database, VIP database, and WanFang database. The primary efficacy outcome for our meta-analysis was all VTE and all-cause mortality. The secondary efficacy outcomes included major VTE, non-fatal pulmonary embolism, and mortality. The primary safety outcome was bleeding events, categorized as major, clinically relevant non-major, or minor events.
Four RCTs, involving 14 065 patients, were included in our meta-analysis. Compared to enoxaparin, thromboprophylaxis with apixaban was associated with significantly fewer VTE and all-cause mortality (8346 patients, risk ratio (RR): 0.63, 95%CI 0.42 - 0.95) and similar incidence of bleeding events (major bleeding, 11 525 patients, RR 0.76, 95%CI 0.43 - 1.33; clinically relevant non-major bleeding, 11 525 patients, RR 0.83, 95%CI 0.69 - 1.01; and minor bleeding, 11 828 patients, RR 0.93, 95%CI 0.79 - 1.09). However, our meta-analysis revealed similar effects of apixaban with enoxaparin for thromboprophylaxis with regard to the secondary efficacy outcomes.
Apixaban was more effective than recommended dose of enoxaparin and had a similar safety profile for thromboprophylaxis after hip and knee arthroplasty. But more evidence, especially well designed head-to-head RCTs, is needed to confirm the superior efficacy of apixaban.
依诺肝素通常用于全髋关节或全膝关节置换术后预防静脉血栓栓塞症(VTE)。本研究旨在比较新型口服直接 Xa 因子抑制剂阿哌沙班与依诺肝素的疗效和安全性。
我们在 PubMed、Cochrane 图书馆、Embase 中国生物医学文献数据库、中国期刊全文数据库、维普数据库和万方数据库中进行了相关随机对照试验(RCT)的荟萃分析。我们荟萃分析的主要疗效结局是所有 VTE 和全因死亡率。次要疗效结局包括主要 VTE、非致命性肺栓塞和死亡率。主要安全性结局是出血事件,分为主要、临床相关非重大或轻微事件。
我们的荟萃分析纳入了四项 RCT,涉及 14065 例患者。与依诺肝素相比,阿哌沙班预防血栓形成与 VTE 和全因死亡率显著降低相关(8346 例患者,风险比[RR]:0.63,95%CI 0.42-0.95),出血事件发生率相似(大出血,11525 例患者,RR 0.76,95%CI 0.43-1.33;临床相关非重大出血,11525 例患者,RR 0.83,95%CI 0.69-1.01;轻微出血,11828 例患者,RR 0.93,95%CI 0.79-1.09)。然而,我们的荟萃分析显示,阿哌沙班与依诺肝素在预防髋膝关节置换术后血栓形成的次要疗效结局方面具有相似的效果。
阿哌沙班比推荐剂量的依诺肝素更有效,且在髋膝关节置换术后预防血栓形成方面具有相似的安全性。但需要更多证据,特别是精心设计的头对头 RCT,以证实阿哌沙班的优越疗效。