Meta-analysis Of The Efficacy And Safety Of Oral Coagulation Factor Xa Inhibitors In The Treatment Of Venous Thromboembolism

Objective: Oral coagulation factor Xa inhibitor is a new drug to treat venous thromboembolism.Due to the lack of clinical trials and indicators,the meta-analysis results of the existing effectiveness and safety are still debatable.This study will include more Randomized Controlled Trial(RCT)on the basis of the original Meta-analysis,further evaluate the effectiveness and safety of oral coagulation factor Xa inhibitors in the treatment of venous thromboembolism,and provide more accurate suggestions for clinical application.Methods: In the databases of Web of Science,Ovid,Embase,Pubmed,The Cochrane Central Register of Controlled Trials,Sino Med,CNKI,Wanfang,VIP,the corresponding literatures about oral coagulation factor Xa inhibitors in the treatment of venous thromboembolism were searched(the search started from the establishment of the database to March 2023).According to the established criteria for inclusion and exclusion of literatures,the literatures were screened in Chinese and English,and relevant RCTs were obtained.Review Manager 5.3 statistical software was used to evaluate the quality of the included literatures,and the efficacy of oral coagulation factor Xa inhibitors was analyzed with venous thromboembolism,deep venous thrombosis(including subtypes)and pulmonary embolism(including subtypes)as indicators,as well as the safety analysis with major bleeding,clinically relevant non-major bleeding and minor bleeding as indicators.Results: A total of 18346 articles were obtained after searching the database,and 108 RCTs articles met the inclusion criteria.The total number of people included in the study is130605,of which the maximum sample size of a single study is 12019,and the research sites included Canadian,China,Australian and other countries and regions,and the clinical trial data included as a whole had the characteristics of low risk of bias,so the literature included in this study was of high quality.Oral coagulation factor Xa inhibitor can significantly reduce venous thromboembolism(compared with blank control: [OR=0.34,95%CI(0.20,0.57),P<0.0001];compared with placebo: [OR=0.38,95%CI(0.32,0.45),P<0.00001]),deep vein thrombosis(compared with blank control: [OR=0.46,95%CI(0.29,0.73),P=0.0009])and pulmonary embolism(compared with placebo: [OR=0.52,95%CI(0.38,0.73),P<0.0001]).Further study found that the curative effect of oral coagulation factor Xa inhibitor was also better than that of positive drugs already used in clinic(venous thromboembolism:[OR=0.63,95%CI(0.54,0.72),P<0.00001];deep vein thrombosis: [OR=0.63,95%CI(0.54,0.74),P<0.00001];pulmonary embolism: [OR=0.76,95%CI(0.65,0.88),P=0.0003]).Moreover,there was no significant difference with the bleeding events caused by positive drugs(major bleeding: [OR=0.98,95%CI(0.86,1.11),P=0.71);clinically related non-major bleeding: [OR=1.09,95%CI(0.94,1.28),P=0.27];minor bleeding:[OR=1.09,95%CI(0.97,1.22),P=0.16]).In addition,the effect of oral coagulation factor Xa inhibitor in the treatment of different subtypes of deep vein thrombosis is better than that of positive drugs that have been applied in clinic.Conclusion: Oral coagulation factor Xa inhibitor is superior to the positive drugs used in clinic in the treatment of venous thromboembolism,so it is recommended to be used in clinic.