利伐沙班用于骨科术后患者静脉血栓栓塞预防有效性和安全性的Meta分析

Efficacy and safety of rivaroxaban for thromboprophylaxis after orthopedic surgery: a Meta-analysis

目的评价利伐沙班在用于骨科术后患者静脉血栓栓塞预防方面的有效性和安全性。方法系统检索Pub Med、Em Base、Cochrane Library、Web of Science、Clinical Trials、中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方数据库,检索时间均从建库至2016年8月。筛选出利伐沙班单药或者联合其他常规用药用于骨科术后患者静脉血栓预防的所有随机对照试验(RCTs),比较总静脉血栓栓塞、严重静脉血栓栓塞、深静脉血栓、肺栓塞、全因死亡、症状性静脉血栓栓塞等有效性结局及出血、大出血、临床相关非大出血、轻微出血、伤口并发症等安全性结局事件的发生率。结果以相对危险系数(RR)及其95%置信区间(CI)表示,用Rev Man 5.3软件进行Meta分析。结果共纳入32项RCTs研究,涉及17061例患者,其中试验组9167例,对照组7894例。Meta分析结果显示,与低分子肝素相比,在症状性静脉血栓栓塞、总静脉血栓栓塞、严重静脉血栓栓塞、深静脉血栓事件发生率方面,试验组显著低于对照组(P<0.05),其他安全性指标差异均无统计学意义;与阿司匹林相比,在总静脉血栓栓塞、深静脉血栓事件发生率方面,试验组显著低于对照组(P<0.05),其他安全性指标差异均无统计学意义;与阿哌沙班相比,在有效性及安全性方面差异均无统计学意义。结论利伐沙班用于骨科术后患者静脉血栓栓塞预防的疗效显著优于低分子肝素及阿司匹林,且不会显著增加出血、伤口并发症等风险。

Objective To further evaluate the rivaroxaban in the thromboprophylaxis after Methods PubMed, EmBase, Cochrane Clinical Trials, CNKI, CBM and Wanfang efficacy and safety of orthopedic surgery. Library, Web of Science, database were systematically searched. All databases had been searched from established up to August 2016. All randomized controlled trials （RCTs） of rivaroxaban therapy in patients after orthopedic surgery were selected. Meta - analysis was carried out by using RevMan 5.3 software. The incidence of total venous thromboembolism （ VTE ）, major VTE, deep vein thrombosis （ DVT）, pulmonary bleeding, embolism （ PE ）, all - cause mortality, symptomatic VTE, major bleeding （CRNMB） , minor bleeding clinical relevant non and wound complication - major bleeding were compared and the results were presented with risk ratio （RR） with 95% confidence interval （CI）. Results Totally 32 RCTs of 17061 cases were included in this study, including 9167 cases accepted rivaroxaban （treatment group）, other of 7894 cases accepted other drugs （control group）. The results of Meta -analysis were as follows. The incidence of symptomatic VTE, total VTE, major VTE and DVT in the rivaroxaban group was lower than that in the low molecular heparin group （ P 〈 0. 05 ）. The incidence of total VTE, and DVT in rivaroxaban group was lower than that in aspirin group （P 〈 0. 05 ）. There was no significant difference in the efficacy and safety between the rivaroxaban and apixaban group （P 〉 0. 05 ）. Conclusion In the thromboprophylaxis after orthopedic surgery, efficacy of rivaroxban is better than that of traditional anticoagulant therapy and it will not increase the risk of adverse events such as bleeding and wound complication.