阿哌沙班预防骨科大手术后静脉血栓栓塞的Meta分析

Apixaban for prevention of venous thromboembolism after major orthopedic surgery： a Meta-a-nalysis

目的系统评价阿哌沙班与依诺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。方法应用Cochrane系统评价方法计算机检索cochrane Library、PubMed、EMBASE、中国生物医学文献数据库、中国期刊全文数据库和维普数据库，并手工检索相关领域杂志。检索不受语种限制，时间均从建库至2012年3月，收集阿哌沙班与依诺肝素比较预防骨科大手术后VTE的所有随机对照试验。根据Cochrane协作网推荐的“风险评估工具”进行偏倚风险评估，用RevMan5．1软件进行统计学分析。结果最终纳入4个随机对照试验，共12897例患者。阿哌沙班与依诺肝素比较，总的VTE和各种原因所致的死亡[相对危险度（RR）=0．63，95％可信区间（CI）0．41，0．96]、主要VTE（RR=0．59，95％CI 0．19，0．98）、症状性深静脉血栓（RR=0．50，95％CI 0．26，0．97）等方面差异有统计学意义，在致死性肺栓塞方面差异无统计学意义（RR=1．57，95％CI 0．41，5．99）。对于全膝关节置换患者，阿哌沙班组在严重出血事件（RR=0．55，95％CI 0．32，0．96）、总的出血事件（RR=0．79，95％CI 0．66，0．95）发生率上低于依诺肝素组，而对于全髋关节置换患者，两组之间差异无统计学意义。药物相关严重不良事件发生率，两者差异无统计学意义（RR=0．97，95％CI 0．59，1．58）。结论阿哌沙班预防骨科大手术后VTE的疗效肯定，能显著降低术后VTE的风险。

Objective To systematically assess the clinical efficacy and safety of apixaban versus enoxaparin in the prevention of venous thromboembolism （VTE） after major orthopedic surgery. Metoils Based on the principles and methods of Cochrane systematic review, the Cochrane Library, PubMed, EMBASE, Chinese Bio-medicine Database, China Journal Full-text Database, VIP Database were searched from their establishment to March 2012 in whatever languages. Related journals were hand- searched as well. Randomized controlled trials （RCTs） of comparing apixaban and enoxaparin in the prvention of venous thromboembolism after major orthopedic operation were included. Cochrane Collabortion＇ s tool was used for assessing risk of bias in the included trials. Cochrane Collaboration＇ s software RevMan 5.1 was used for statistical analysis. Results Four RCTs totaling 12 897 patients were includ- ed. Apixaban treatment showed significant differences in aspects of total VTE and all-cause mortality [ rel- ative risk （RR） =0.63, 95%CI（0.41, 0.96） ], major VTE [RR =0.59, 95%CI（0.19, 0.98）] and symptomatic deep vein thrombosis （DVT） [ RR = O. 50, 95% CI （0.26, 0.97 ） ] when compared with enoxaparin, but the difference in fatal pulmonary embolism was insignificant[ RR = 1.57, 95% CI（0. 41, 5.99 ）] For patients undergoing total knee arthroplasty, apixaban was associated with significantly fewer major bleeding events [ RR = 0.55, 95% CI（0. 32,0.96） ] and fewer total bleeding events [ RR = 0.79, 95 % CI（0. 66, 0.95 ） ] than enoxaparin. For patients undergoing total hip replacement, however, the two treatments revealed no statistically significant differences. With regard to the incidence of drug-related srious adverse events, the two treatments displayed no significant difference [ RR = 0.97, 95% CI（ 0. 59, 1.58） ]. Conclusion Apixaban is effective in the prevention of VTE after major orthopedic surgeryand can significantly reduce the risk of postoperative VTE.