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基于欧洲药品管理局药物警戒数据库自发报告的直接口服抗凝药物剂量错误描述性分析

A Descriptive Analysis of Direct Oral Anticoagulant Drugs Dosing Errors Based on Spontaneous Reports from the EudraVigilance Database.

作者信息

Morgovan Claudiu, Dobrea Carmen Maximiliana, Chis Adriana Aurelia, Juncan Anca Maria, Arseniu Anca Maria, Rus Luca Liviu, Gligor Felicia Gabriela, Ardelean Simona Alexandrina, Stoicescu Laurentiu, Ghibu Steliana, Frum Adina

机构信息

Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.

Department of Pharmaceutical Sciences, Faculty of Pharmacy, "Vasile Goldis" Western University of Arad, 310025 Arad, Romania.

出版信息

Pharmaceuticals (Basel). 2023 Mar 17;16(3):455. doi: 10.3390/ph16030455.

DOI:10.3390/ph16030455
PMID:36986554
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10056464/
Abstract

Direct oral anticoagulant drugs (DOACs) interfere with the coagulation process, thus improving patient care for those who require anticoagulant treatment. This study presents a descriptive analysis of adverse reactions (ADRs) attributed to DOAC dosage errors (overdose, underdose, and improper dose). The analysis was performed based on the Individual Case Safety Reports from the EudraVigilance (EV) database. Results show that data reported for rivaroxaban, apixaban, edoxaban, and dabigatran are mostly regarding underdosing (51.56%) compared to overdosing (18.54%). The most dosage error reports were identified for rivaroxaban (54.02%), followed by apixaban (33.61%). Dabigatran and edoxaban had similar percentages (6.26% and 6.11%, respectively) regarding dosage error reports. Since coagulation issues can become life-threatening events, and factors such as advanced age and renal failure can influence the pharmacokinetics of drugs, the correct usage of DOACs is of utmost importance for the management and prevention of venous thromboembolism. Thus, the collaboration and the complementarity of knowledge of physicians and pharmacists may offer a reliable solution for DOAC dose management and improve patient care.

摘要

直接口服抗凝药物（DOACs）会干扰凝血过程，从而改善需要抗凝治疗患者的护理。本研究对归因于DOAC剂量错误（过量、不足和不当剂量）的不良反应（ADR）进行了描述性分析。该分析是基于欧洲药品不良反应数据库（EudraVigilance，EV）中的个例安全报告进行的。结果显示，与过量用药（18.54%）相比，利伐沙班、阿哌沙班、依度沙班和达比加群报告的数据大多与用药不足（51.56%）有关。利伐沙班的剂量错误报告最多（54.02%），其次是阿哌沙班（33.61%）。达比加群和依度沙班的剂量错误报告比例相似（分别为6.26%和6.11%）。由于凝血问题可能会危及生命，而且高龄和肾衰竭等因素会影响药物的药代动力学，因此正确使用DOACs对于静脉血栓栓塞的管理和预防至关重要。因此，医生和药剂师知识的协作与互补可能为DOAC剂量管理提供可靠的解决方案，并改善患者护理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d9d/10056464/fa7ee699f194/pharmaceuticals-16-00455-g007a.jpg
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