Objective To systematically evaluate the safety and efficacy of the new oral thrombin inhibitor and vitamin K antagonist in the treatment of acute venous thromboembolism, and to provide evidence for the choice of drugs for acute venous thromboembolism.Methods A Randomized Controlled Trials (RCT) study of the efficacy and safety of oral thrombin inhibitors and vitamin K antagonists in patients with acute venous thromboembolism was searched for by PubMed, EMbase, The Cochrane Library, WanFang Data, CBM and CNKI. The retrieval time limit is defined as building the library to March 2016. Meta-analysis was performed using RevMan 5.3 software for each outcome.Results A total of 7 RCTs involving 29932 patients were included. The results of meta-analysis showed that: There is no significant difference of effect between oral thrombin inhibitor group and vitamin K antagonist group [OR=0.93, 95%CI (0.81, 1.06),P=0.28]. The incidence of major bleeding in the new thrombin inhibitor group was significantly lower than that in the vitamin K antagonist group [OR=0.61, 95%CI (0.50, 0.75), P<0.00001].Conclusion New thrombin inhibitors can provide a better therapeutic effect for patients with acute venous thromboembolism, and its safety is also higher. But its safety and efficacy of treatment in domestic patients with acute venous thromboembolism still need to be verified in domestic RCTs with more samples.%目的：系统评价新型口服凝血酶抑制剂与维生素K拮抗剂治疗急性静脉血栓栓塞的安全性及有效性，以期为临床急性静脉血栓栓塞治疗药物的选择提供证据。方法计算机检索PubMed、EMbase、The Cochrane Library、WanFang Data、CBM、CNKI，查找有关口服新型凝血酶抑制剂与维生素K拮抗剂对急性静脉血栓栓塞患者治疗安全性与有效性的随机对照试验（RCT）。检索时限定义为建库至2016年3月。各结局指标采用RevMan 5.3软件进行Meta分析。结果最终纳入7个RCT，共计29932例患者。Meta分析结果显示：新型凝血酶抑制剂组静脉血栓复发率较维生素K拮抗剂组并未见明显差异（OR=0.93，95%CI：0.81~1.06，P=0.28）。新型凝血酶抑制剂组大出血发生率较维生素K拮抗剂组明显降低（OR=0.61，95%CI：0.50~0.75，P＜0.00001）。结论新型凝血酶抑制剂能够为急性静脉血栓栓塞患者提供较为良好的治疗效果，其安全性亦较高。但其对国内急性静脉血栓栓塞患者治疗效果的安全性与有效性尚需国内更多大样本量RCT加以验证。
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