| 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 According to the PICOS,the search strategy used the key words.The Cochrane Library,Pub Med,EMBASE,Chinese Journal Full-text Database(CNKI),Wang Fang Data,VIP database(VIP)were searched from their establishment to February 2017.Language restrictions for Chinese and English.All the randomized controlled trials(RCTs)of edoxaban compared with low molecular heparin to prevent VTE after orthopedic surgery were collected.Risk of bias was assessed using the criteria of the Cochrane back review group.The data of all included trials were extracted by two reviewers independently.The meta-analysis of included RCTs was performed to assess the efficacy and safety of edoxaban for total VTE,symptomatic deep vein thrombosis(DVT),asymptomatic DVT,pulmonary embolism(PE),all-cause mortality,venous thrombosis-related deaths,total bleeding events,major bleeding events,clinically relevant non-major bleeding events,minor bleeding events,Drug-related adverse drug reaction.All data were analyzed by Rev Man 5.3.5.Funnel plots are used to assess the degree of potential publication bias by STATA 13.0 and sensitivity analysis was assessed by comparing with the difference of effect model and the influence analysis.Result Five RCTs involving 2585 patients were included.In terms of effectiveness,the total VTE and asymptomatic DVT were statistically significantly different compared with low molecular heparin,RR=0.47,95%CI(0.38,0.58),RR=0.47,95%CI(0.31,0.71).Symptomatic DVT and all-cause mortality was not statistically significant,RR=3.95,95%CI(0.44,35.10),RR=2.07,95%CI(0.11,38.20).Edoxaban 15 mg,30mg,60 mg,90mg of total VTE were significant differences compared with low molecular heparin,RR=066,95%CI(0.49,0.89),RR=0.50,95%CI(0.38,0.65),RR=0.35,95%CI(0.23,0.52),RR=0.24,95%CI(0.15,0.40).East Asians and Non-east Asians of edoxaban were superior to low molecular heparin in total VTE,the differences were statistically significant,RR=0.52,95%CI(0.35,0.78),RR=0.44,95%CI(0.34,0.56).In terms of safety,edoxaban was associated with significantly fewer Drug-related adverse reactions RR=0.63,95%CI(0.42,0.94).With regard to the incidence of major bleeding events,clinically relevant non-major bleeding events and minor bleeding events,the two treatments displayed no significant difference,RR=0.99,95%CI(0.40,2.43),RR=1.36,95%CI(0.79,2.36),RR=1.26,95%CI(0.99,1.62).The total bleeding was higher than the low molecular heparin,RR=1.22,95%CI(1.01,1.49).There was no significant difference in total bleeding events between edoxaban 15 mg,30mg,90 mg and the low molecular heparin.RR=0.97,95%CI(0.55,1.70),RR=1.21,95% CI(0.99,1.48),RR=6.80,95%CI(0.85,54.71).while edoxaban 60 mg was significant difference,RR=8.37,95%CI(1.07,65.36).East Asians and non-east Asians of total bleeding were no significant difference in two groups,RR=1.18,95%CI(0.97,1.44),RR=5.46,95%CI(0.74,40.18).Conclusion Based on the results of meta-analysis,edoxaban was superior to low molecular heparin in the prevention of VTE after major orthopedic surgery,but the total bleeding was higher.Edoxaban 15 mg,30mg may be a superior dose,but further research is needed. |
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