| Objective:Studies have shown that the risk of thrombosis and bleeding in aged people is high,especially in elderly people,so anticoagulation therapy needs to be cautious.As a new oral anticoagulant,varoxaban has convenient use and quick effect,without detection of coagulation.It has been widely used in patients of hip and knee replacement for postoperative VTE prevention,the treatment of DVT and PE patients and reducing the risk of recurrent and reducing the stroke and systemic embolism risk in non valvular AF patients.The main safety problem of varoxaban is hemorrhagic adverse reactions,especially clinical bleeding,which is often life-threatening.The main cause of bleeding caused by varoxaban is that varoxaban directly inhibited the FXa factor and prolonged the clotting time.In addition,after the listing of varoxaban,there are some spontaneous reports that varoxaban can cause thrombocytopenia and thrombocytopenia can also cause bleeding.Because of the decline of liver and kidney function in elderly patients,the hemorrhagic adverse reactions of varoxaban are more prominent.Becausing of less clinical study in assessment of the benefit and risk of varoxaban,our study aims to explore the safety of varoxaban in elderly patients and provide clinical reference resources of varoxaban for elderly patients.Method:This is a retrospective study.Retrospectively analysis 46 patients(age?80years)using varoxaban during the period of hospitalization in the cadre ward of No.1 Hospital of Jilin University from 2015.1-2016.12.The patients of using other anticoagulants after varoxaban have been ruled out.Collect the basic information of patients about age and gender.Collect the laboratory indexes consisting of liver function,renal function,blood routine and coagulation routine.Figure out the situation of patients using rivaroxaban's indications,usage and adverse reaction.Figure out the situationg of using antiplatelet drugs and the history of gastrointestinal bleeding.Figue out the incidence of hemorrhagic events in group being investigated.Analyse the relationship between gender,age,anemia,antiplatelet drugs,usage of varoxaban,history of gastrointestinal bleeding and hemorrhagic events.Compare the changes of platelet count before and after using varoxaban.In this study,data were analyzed by statistical software SPSS17.0,P < 0.05 was statistically significant.Result:Patients in this study being investigated was 46 cases,with an average age of 87±4.6,a maximum age of 95 years and a minimum age of 80 years.AF patients was 6 cases(starting daily dose: 10 mg daily in 2 cases;5mg daily in 1 case).PE patients was 3 cases(starting daily dose: 15 mg daily in 2cases;10mg daily in 1 case).DVT patients was 21 cases(initial daily dose: 20 mg daily in 1 case;15mg daily in 2 cases,;10mg daily in 18 cases).VTE prevention patients was 16 cases(initial daily dose: 10 mg daily in 15 cases;5mg daily in 1case).In patients being investigated in this study,the incidence of bleeding was 15.2%(7/46),and the incidence of fatal hemorrhage was 0.In patients being investigated in this study,the incidence of bleeding in AF patients was 33.3%(2/6),the incidence of bleeding in PE patients was 33.3%(1/3),the incidence of bleeding in DVT patients was 14.3%(3/21),the incidence of bleeding in DVT patients was 6.2%(1/16),P=0.236,the difference was not statistically significant.The incidence of bleeding in this study vs that in large phase III clinical trial of varoxaban:in the whole,P=0;in AF group,P=0.019;in PE group,P=0.031,in DVT group,P=0;in VTE prevention group,P=0;the differences were statistically significant.In patients being investigated in this study: the incidence of bleeding in male group was 15.6%(5/32),the incidence of bleeding in female group was(2/14),P=0.6,the difference was not statistically significant.In patients being investigated in this study: the incidence of bleeding in anemia group was 16.7%(3/18),the incidence of bleeding in non anemia group was 14.3%(4/28),P=0.6,the difference was not statistically significant.In patients being investigated in this study: the incidence of bleeding in patients with antiplatelet drugs was 6.7%(1/15),and the incidence of bleeding in patients without antiplatelet drugs was 19.4%(6/31),P=0.3,the difference was not statistically significant.In patients being investigated in this study : the incidence of gastrointestinal bleeding in patients with history of gastrointestinal bleeding was 100%(2/2),the incidence of bleeding in patients without history of gastrointestinal bleeding was 6.8%(3/44),P=0.01,the difference was statistically significant.In patients being investigated in this study:in the analysis of the correlation between age and bleeding events,P=0.173,there was no statistically significant difference.In patients being investigated in this study:in the analysis of the correlation between the duration of medication and bleeding events,P=0.4,there was no statistically significant difference.In patients being investigated in this study:in the analysis of the correlation between the average daily dose and bleeding events,correlation coefficient B=0.677,Exp(B)=1.968,95%CI[1.191-3.253],P=0.008,correlation was statistically significant.In patients being investigated in this study:the change of platelet count before and after using varoxaban,P=0.4,the difference was no statistically significant.Conclusion:1,The incidence of bleeding in elderly patients using varoxaban was higher than that of normal age group,but age ? 80,age was not related to bleeding events;in patients being investigated in this study,bleeding events were mainly gastrointestinal bleeding and mucocutaneous hemorrhage.2,In elderly patients,the history of gastrointestinal bleeding and increasing average daily dose were risk factors for bleeding events;gender,anemia,the use of anti platelet aggregation drugs and duration of using varoxaban were not related to bleeding events.3,In elderly patients,varoxaban was no effect on platelet count. |
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