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达比加群:药物及其剂量与中风和出血风险的临床关联。

Dabigatran: Clinical correlation of drug and its dose with risk of stroke and bleeding.

作者信息

Shaji Anitta, Thomas Doody, Saju Midhuna, Abraham Suja, Nayak Ramdas

机构信息

Nirmala College of Pharmacy, Muvattupuzha, Kerala, India.

Department of Cardiology, Rajagiri Hospital, Aluva, Kerala, India.

出版信息

Perspect Clin Res. 2023 Jan-Mar;14(1):26-31. doi: 10.4103/picr.picr_171_21. Epub 2022 Nov 29.

Abstract

BACKGROUND

Dabigatran is the first oral direct thrombin inhibitor which is endorsed by Food and Drug Administration in the prevention of embolic events in patients with nonvalvular atrial fibrillation. Suitable dose of the drug for the patient is selected based on CHA2DS2-VASc score and HAS-BLED score.

AIM

To determine and compare the risk of occurrence of stroke and bleeding after the initiation of dabigatran therapy in patients prescribed with this drug.

METHODS

Patients with more than 18 years who were prescribed with dabigatran during 2017-2019 in a tertiary care hospital were selected for the study. Most of the patient's prescriptions contained an antiplatelet, so a comparison was made between the clinical outcomes of patients given with dabigatran alone and dabigatran with an antiplatelet because antiplatelet can have effects on the safety as well as efficacy profile of dabigatran.

RESULTS

Out of 75 patients enrolled in the study, 42 patients were in the dabigatran with the antiplatelet group and 33 were in the dabigatran alone group. In both the groups, there was a significant reduction in CHADS-VASc score, i.e., 2.58 ± 1.32-1.94 ± 1.21 in dabigatran-treated patients within 6 months, and the score was lowered from 3.76 ± 1.22 to 2.92 ± 1.22 in other groups. The mean value of the HAS-BLED score of dabigatran was reduced from 1.15 ± 0.83 to 0.84 ± 0.78 and that of dabigatran with antiplatelet group from 2.10 ± 0.94 to 1.74 ± 0.92.

CONCLUSION

It was observed that within 6 months, both the treatment groups showed a reduction in the risk scores. The dabigatran group had lower background risks of stroke and bleeding in comparison to the dabigatran plus antiplatelet group.

摘要

背景

达比加群是首个获美国食品药品监督管理局批准用于预防非瓣膜性心房颤动患者栓塞事件的口服直接凝血酶抑制剂。根据CHA2DS2-VASc评分和HAS-BLED评分来为患者选择合适的药物剂量。

目的

确定并比较服用达比加群治疗的患者开始治疗后发生中风和出血的风险。

方法

选取2017年至2019年在一家三级护理医院开具达比加群处方的18岁以上患者进行研究。大多数患者的处方中含有抗血小板药物,因此对单独服用达比加群的患者与服用达比加群联合抗血小板药物的患者的临床结局进行了比较,因为抗血小板药物可能会对达比加群的安全性和疗效产生影响。

结果

在纳入研究的75例患者中,42例患者属于达比加群联合抗血小板药物组,33例患者属于单独使用达比加群组。在两组中,CHADS-VASc评分均显著降低,即达比加群治疗的患者在6个月内从2.58±1.32降至1.94±1.21,其他组从3.76±1.22降至2.92±1.22。达比加群组的HAS-BLED评分平均值从1.15±0.83降至0.84±0.78,达比加群联合抗血小板药物组从2.10±0.94降至1.74±0.92。

结论

观察到在6个月内,两个治疗组的风险评分均有所降低。与达比加群加抗血小板药物组相比,达比加群组的中风和出血背景风险较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4eb7/10003582/1a3fba0b14d5/PCR-14-26-g001.jpg

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