不同剂量利伐沙班与依诺肝素预防全髋关节置换后静脉血栓形成:安全及有效性的Meta分析

Different doses of rivaroxaban versus enoxaparin for prevention of venous thromboembolism after total hip arthroplasty: a meta-analysis of safety and efficacy

背景:利伐沙班和依诺肝素是预防全髋关节置换后静脉血栓栓塞常用药物,对其安全性及疗效仍有一定的争议,目前国内外还没有对利伐沙班最优剂量的研究。目的:系统评价利伐沙班对比依诺肝素预防全髋关节置换后静脉血栓栓塞的疗效及安全性。方法:计算机检索The Cochrane Library(2014年第9期)、Medline、EMbase、PubM ed、维普、万方、CNKI等数据库(检索时间均从建库至2015年9月),有关利伐沙班对比依诺肝素预防全髋关节置换后静脉血栓栓塞的随机对照试验,对两种治疗方法的深静脉血栓、主要静脉血栓栓塞、大出血事件、非大出血及小出血事件进行Meta分析。结果与结论:(1)总体结果显示,利伐沙班预防全髋关节置换后静脉血栓栓塞的效果优于依诺肝素,但出血风险较依诺肝素更大;(2)亚组分析结果显示,利伐沙班用药剂量为10,30 mg/d时,预防深静脉血栓的疗效较依诺肝素好(P<0.05);用药剂量为10 mg/d时,预防主要静脉血栓栓塞的疗效较依诺肝素好(P<0.05);用药剂量为30,40,60 mg/d时,出血风险较依诺肝素明显(P<0.05);(3)综合亚组分析结果可以得出结论,利伐沙班用药剂量为10 mg/d时的疗效及安全性均优于依诺肝素;(4)受纳入研究的数量和质量的限制,上述结论有待更多高质量、大样本多中心随机对照试验加以验证。

BACKGROUND： Rivaroxaban and enoxaparin are commonly used drugs to prevent venous thromboembolism after total hip arthroplasty. There is still some controversy on the safety and efficacy. At present, there is no research on the optimal dose of rivaroxaban in domestic and foreign countries. OBJECTIVE： To systematically review the protective effect and safety for prevention of venous thromboembolism after total hip arthroplasty between rivaroxaban and enoxaparin. METHODS： Databases were retrieved including The Cochrane Library（Issue 9, 2014）, Medline, EMbase, Pub Med, VIP, Wan Fang and CNKI（from database foundation to September 2015） for randomized controlled trials about rivaroxaban compared with enoxaparin to prevent venous thromboembolism after total hip arthroplasty. Meta-analysis was conducted in two kinds of treatment of deep vein thrombosis, major venous thromboembolism, major bleeding events, non-major bleeding and minor bleeding events.RESULTS AND CONCLUSION：（1） Overall results showed that： efficacy of rivaroxaban was better than enoxaparin in the prevention of venous thromboembolism after total hip arthroplasty, but rivaroxaban has greater risk for hemorrhage.（2） Subgroup analysis results demonstrated that the efficacy of rivaroxaban at 10 and 30 mg/d was better than that of enoxaparin in the prevention of venous thromboembolism（P〈0.05）. The efficacy of rivaroxaban at 10 mg/d was better than that of enoxaparin in the prevention of venous thromboembolism（P〈0.05）. The risk of hemorrhage when using rivaroxaban at 30, 40 and 60 mg/d was higher than that of enoxaparin（P〈0.05）.（3） Comprehensive subgroup analysis results showed that the efficacy and safety of rivaroxaban at 10 mg/d were better than enoxaparin.（4） Due to the limited quantity and quality of included studies, these conclusions need more high-quality and large multicenter randomized controlled trials to verify.