依度沙班预防骨科大手术后静脉血栓栓塞的meta分析

Edoxaban for Prevention of Venous Thromboembolism after Major Orthopedic Surgery: A Meta-Analysis

关键词:  依度沙班  低分子肝素  随机对照试验  静脉血栓栓塞  meta分析

Key words:  edoxaban  low molecular heparin  randomized controlled trial  venous thromboembolism  meta-analysis

摘要:

目的 比较依度沙班与低分子肝素预防骨科大手术后静脉血栓栓塞（venous thromboembolism，VTE）的有效性和安全性。方法 检索Cochrane Library、PubMed、EMBASE、中国知网、万方和维普科技期刊等数据库。收集依度沙班与低分子肝素预防骨科大手术后VTE随机对照试验。应用RevMan 5.3.5软件进行分析。结果 最终纳入5项研究，涉及2 585例患者。依度沙班组总VTE发生率[RR=0.47，95% CI（0.38，0.56），P<0.000 01]、无症状性深静脉血栓发生率[RR=0.47，95% CI（0.31，0.71），P=0.000 4]均低于低分子肝素组。依度沙班组总出血事件发生率高于低分子肝素组[RR=1.22，95% CI（1.01，1.49），P=0.04]。亚组分析发现依度沙班不同剂量组总VTE发生率均低于低分子肝素组，15 mg组、30 mg组与低分子肝素组总出血事件发生率差异均无统计学意义。结论 依度沙班预防骨科大手术后VTE优于低分子肝素，但增加了总出血事件发生率。15，30 mg依度沙班可能为较安全剂量。

Abstract:

OBJECTIVE To evaluate the efficacy and safety of edoxaban and low molecular heparin in the prevention of venous thromboembolism (VTE) after major orthopedic surgery. METHODS The Cochrane Library, PubMed, EMBASE, CNKI, WanFang, VIP database (VIP) were searched. All the randomized controlled trials of edoxaban compared with low molecular heparin to prevent VTE after orthopedic surgery were collected. All data were analyzed by RevMan 5.3.5. RESULTS Five RCTs involving 2 585 patients were included. Compared with low molecular heparin, edoxaban reduced the total VTE events[RR=0.47, 95%CI (0.38, 0.56), P<0.000 01] and reduced the asymptomatic deep vein thrombosis events[RR=0.47, 95%CI (0.31, 0.71), P=0.000 4]. The total bleeding events of edoxaban was higher than the low molecular heparin[RR=1.22, 95% CI (1.01, 1.49), P=0.04]. In the subgroup analysis different doses of edoxaban reduced the total VTE events and the incidences of total bleeding in edoxaban 15 mg and 30 mg were no significant difference compared with low molecular heparin. CONCLUSION Edoxaban is superior to low molecular heparin in the prevention of VTE after major orthopedic surgery, but the total bleeding was higher. The 15 mg and 30 mg edoxban may be safe doses.