Clinical trial of rivaroxaban in the treatment of anticoagulation in patients with pulmonary embolism during maintenance period
Objective To compare the application effect of different doses of rivaroxaban on anticoagulation therapy in patients with pulmonary thromboembolism(PTE)during maintenance period,and to evaluate its benefit-risk.Methods The patients with PTE were divided into conventional-dose group and low-dose group according to the cohort method.Conventional-dose group were given of rivaroxaban 15 mg,twice a day and changed to 20 mg once a day after 3 weeks;low-dose group were given rivaroxaban 10 mg twice a day and changed to 15 mg once a day after 3 weeks,and the anticoagulation treatment time in both groups was ≥ 3 months.The clinical efficacy in the two groups was recorded.Serum indicators[D-dimer(D-D),N-terminal pro-brain natriuretic peptide(NT-proBNP),cardiac troponin Ⅰ(cTn Ⅰ)]and liver-kidney function[glutamic-pyruvic transaminase(GPT),glutamic-oxaloacetic transaminase(GOT),blood urea nitrogen(BUN),creatinine(Cr)]were compared before treatment and after 3 months of treatment.The patients were followed up for 3 months after treatment,and the endpoint events such as PTE recurrence and death and the bleeding events were recorded in the two groups.Results There were 42 cases in conventional-dose group,44 cases in low-dose group.After 3 months of treatment,the total effective rates in low-dose group and conventional-dose group were both 100.00％,with no significant difference(P＞0.05).After 3 months of treatment,serum D-D levels in low-dose group and conventional-dose group were(0.31±0.08)and(0.29±0.07)mg·L-1,NT-proBNP levels were(125.49±24.16)and(121.39±22.08)ng·L-1,cTn Ⅰ levels were(0.02±0.00)and(0.02±0.00)μg·L-1,all with significant differences(all P＞0.05).There were no significant changes in GPT,GOT,BUN and Cr in the two groups before and after treatment(all P＞0.05),and there were no statistically significant differences between the two groups(all P＞0.05).The total incidences of bleeding events during follow-up was 6.82％in low-dose group and was 23.81％in conventional-dose group(P＜0.05).Conclusion Compared with conventional-dose rivaroxaban,low-dose rivaroxaban has similar anticoagulant effect,but the latter one can better reduce the risk of bleeding events in patients with PTE.
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