| ObjectiveTo compare the efficacy and safety of dabigatran and warfarin used on th e anticoagulant therapy of elderly patients with non-valvular atrial fibrillation.MethodsSelect the patients with non-valvular atrial fibrillation,of being in the Dep artment of Cardiology of our hospital or visting in outpatient clinic between Se ptember 2016 and January 2017,history of more than 7 days,over 60 years of age.We use CHA2DS2-VASc score and HAS-BLED score assessing for stroke risk and bleeding risk.Patients with CHA2DS2-VASc score?2 and HAS-BLE D score<3 were selected for anticoagulant therapy.In order to use rationally a nticoagulant drugs,the patient's age,sex,height,weight,course of illness,past medical history,medication history,drinking history,etc.were recorded in det ail before the start of treatment,the same of blood routine,urine routine,and st ool routine + occult blood tests.In combination with the patient's economic co nditions and personal wishes,dabigatran or warfarin was selected as an anticoa gulant drug.Patients taking dabigatran as the anticoagulant drug are the observ ation group,patients taking warfarin as the anticoagulant drug are the control group.A total of 33 patients in the observation group(22 males and 11 female s)were given dabigatran 110 mg,twice a day orally.A total of 45 patients in the control group(25 males and 20 females)were given warfarin.The initial dose of warfarin was 3mg or 2.5mg,once a day,monitoring the normalized pr othrombin ratio(INR),adjusting the warfarin dose basing on the INR value,an d keeping the INR between 1.5-2.5,Through outpatient follow-up,telephone fo llow-up and other means,we conducted an average follow-up of 12 months.O bservation indicators of anticoagulation efficacy:presence or absence of atrial t hrombus confirmed by cardiac ultrasound,presence or absence of cranial MRI or new brain embolism confirmed by brain CT,and presence or absence of pe ripheral arterial embolization confirmed by vascular ultrasound.Safety observati ons include bleeding,deaths,and other adverse events during the patient's use of anticoagulant drugs.Bleeding events are classified as major bleeding events and minor bleeding events.Major bleeding refers to bleeding that causes hemo globin falling of at least 20 g/L before entering the group or inputting whole blood of at least 2 units;or symptomatic bleeding of critical sites and organs.Major bleeding includes non-fatal bleeding and fatal bleeding.Except major ble eding events,all other bleeding was considered minor bleeding,including skin an d mucous membranes,gingival bleeding,conjunctival hemorrhage,bloody sputu m,microscopic hematuria,a small amount of melena,or bloody stools.Death refers to death of a patient due to stroke or bleeding,or any other reason.Othe r adverse events included liver and kidney insufficiency,indigestion,and fever.SPSS20.0 software was used to conduct normal test and homogeneity test of variance.Measured data with normal distribution were expressed as meanąst andard deviation.Independent sample t test was used for comparison between groups,and paired sample t test was used in the group.Count data were com pared using chi-square test.All tests were statistically significant at P<0.05.Results1.Medication complianceA total of 2 patients in the observation group withdrew from the trial.On e who had undergone repeated radiofrequency ablation for atrial fibrillation sho wing sinus rhythm after repeated electrocardiograms stopped taking dabigatran 3 months after surgery,and another one was discontinued for economic reasons.A total of 3 patients in the observation group withdrew from the trial.They dropped out of the experiment because of severe cerebral hemorrhage,the inco nvenience of regular detection of INR,spontaneous conversion of sinus rhythm.2.Comparison of the effectiveness of anticoagulant therapyOne case of atrial mural thrombus occurred in the observation group on t he second month after the commencement of anticoagulant therapy.Reexaminat ion of echocardiography showed disappearance of left ventricular thrombus in 3 months after continuous medication.In the control group,one case of acute lef t basal ganglia cerebral embolism confirmed by transcranial brain magnetic reso nance occurred in the third month after initiation of anticoagulant therapy.The INR was 1.10.After the occurrence of cerebral infarction,warfarin was suspe nded and the antiplatelet drug aspirin was replaced.After 2 weeks,there was no new cerebral infarction and cerebral hemorrhage after cranial MRI examinati on,and aspirin was stopped,warfarin anticoagulant therapy was continued.Calc ulated P>0.05,the difference is not statistically significant.Therefore,the effecti veness of dabigatran for anticoagulant treatment is comparable to that of warfar in.3.Comparison of the safety of anticoagulant therapy1.There was no evidence of hepatorenal insufficiency and other serious ad verse reactions before and after treatment of both groups.2.There were no deaths in both groups.One major bleeding occurred in the observation group and the control group,respectively.One patient with cerebr al hemorrhage in the observation group appeared one month after initiation of anticoagulant therapy.Brain CT confirmed left fronto-parietal hemorrhage with a blood loss of 15ml.Dabigatran-induced cerebral hemorrhage could not be ex eluded.Therefore,dabigatran was discontinued and the patient presented to neu rology.After one month review of brain CT,hematoma has been absorbed.Ha If-dosage of dabigatran anticoagulant was temporarily given,and given therapeu tic doses of dabigatran bserved to have no cerebral hemorrhage occurred.One patient with cerebral hemorrhage in the control group appeared there months af ter the start of follow-up.Brain CT confirmed the right frontotemporal lobe he morrhage with a hemorrhage of 60 ml.He immediately stopped taking warfari n.After two days,the symptoms of the patient were worse than before.Repeat ed examinations of the brain showed enlargement of hematoma.Expanded,the patient's consciousness was not recovered after active treatment,so the experim ent was withdrawn.There were 5 cases of minor bleeding in the observation group,including three cases of digestive tract hemorrhage,one case of skin ecchymosis,and on e case of gingival bleeding.Three cases of gastrointestinal hemorrhage showed two cases of tarry stool,one case of dark red bloody stools.All of them tem porarily were delayed the use of dabigatran one times,and no continuous blee ding.Because of less bleeding,they are defined as a minor bleeding event.A total of 14 minor bleeding events occurred in the control group,including one case of gastrointestinal bleeding,five cases of skin ecchymosis,five cases of gingival bleeding,and there cases of conjunctival hemorrhage.One case of gas trointestinal bleeding showed a small amount of dark red bloody stools,monito ring INR 2.30.Suspended warfarin and no further bleeding.After 2 days,the INR was still within the normal range,and warfarin continued to be used.Bee ause of the small amount of bleeding,it was not included in the major bleedi ng category.Thus,there was no significant difference in the incidence of major bleedin g,intracranial hemorrhage,and death between the two groups(P>0.05).The in cidence of minor bleeding in the control group was higher than that in the obs ervation group,and the difference was statistically significant(P<0.05).In sum mary,there is a statistically significant difference in safety between dabigatran and warfarin,dabigatran is slightly more safe than warfarin in anticoagulant th erapy(P<0.05).Conclusionl.In the efficacy of anticoagulant therapy,dabigatran is comparable to that of warfarin.2.In the safety of anticoagulant therapy,dabigatran is superior to warfari n. |
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