Abstract:
AIM To compare the effect of the same dose of domestic ticagrelor (Taiyi) and imported ticagrelor (Belinda) on platelet inhibition rate in patients with coronary heart disease.
METHODS The inpatients who were diagnosed as coronary heart disease in the Department of Cardiology of Xijing Hospital from March 2019 to September 2020 were included, and they did not take tegrenol or clopidogrel in the past month. The patients were randomly divided into Taiyi group (test) (Taiyi 180 mg loading dose, followed by 90 mg, twice a day) and Belinda group (control) (Belinda 180 mg loading dose, followed by 90 mg, twice a day). A total of 200 patients were included, 100 in the test group and 100 in the control group. Both groups were given aspirin 100mg once a day, regardless of whether they had taken aspirin before admission. All patients were followed up for 1 month. The patients were tested by thromboelastography (TEG) 2 hours after taking the loaded dose of ticagrelor and 8 hours after taking the fourth dose of ticagrelor to evaluate the inhibitory effect of domestic and imported ticagrelor on platelets.
RESULTS According to the platelet inhibition effect determined by TEG, the proportion of insensitivity (ineffectiveness) in Belinda group and Taiyi group was 3 (3.0%) and 4 (4.0%); The proportion of clinical onset (drug onset and better inhibition) was 97 (97.0%) and 96 (96.0%), with no statistical difference between the two groups. Eight hours after the fourth administration, the proportion of insensitivity (ineffectiveness) in Belinda group and Taiyi group was 5 (5.0%) and 3 (3.0%), and the proportion of clinical onset (drug onset and better inhibition) was 85 (85.0%) and 84 (84.0%), with no statistical difference between the two groups. In terms of safety, one patient in the control group had intolerable shortness of breath during hospitalization and was replaced with clopidogrel. There were no severe bleeding, death, myocardial infarction and stent thrombosis in the two groups until 1 month of follow-up.
CONCLUSION In this single center, randomized and controlled study, there was no significant difference in the platelet inhibition rate and clinical onset rate (ADP ≥ 30%) between domestic and imported tegrilotene 2 hours after a single drug load and 8 hours after four times of drug administration, and the safety was good.
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