JADER Database-based Analysis of the Association Between Tranexamic Acid and Thromboembolism and Related Risk Factors.

IF 1.8 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

In vivo Pub Date : 2025-06-27 DOI:10.21873/invivo.14025

Natsuko Ishida, Toshihiro Shibata, Yukio Suga, Junko Ishizaki

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引用次数: 0

Abstract

Background/aim: Tranexamic acid (TXA) is widely used as a hemostatic agent and for various other indications, including dermatological and inflammatory conditions. However, its association with thromboembolism in the real-world setting remains unclear. In this study, we aimed to evaluate this association.

Patients and methods: We collected data from the Japan Adverse Drug Event Report database from Q1 2004 to Q3 2020 and performed reporting odds ratio analyses and multivariate logistic regression analysis.

Results: Overall, 1,735,923 reports were analyzed. TXA was the suspected causal drug in 54 cases of venous thromboembolism (VTE) and 8 cases of arterial thromboembolism. A significant signal was detected for VTE (reporting odds ratio=6.61; 95% confidence interval=5.03-8.70) but not for arterial thromboembolism. VTE cases involving TXA were more frequently reported in women and individuals with a body mass index of ≥25 than in other groups.

Conclusion: TXA may be associated with VTE. The findings highlight the importance of careful patient monitoring during TXA administration, particularly in high-risk populations such as women and individuals who are overweight.

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基于JADER数据库的氨甲环酸与血栓栓塞及相关危险因素的相关性分析。

背景/目的：氨甲环酸（TXA）被广泛用作止血剂和各种其他适应症，包括皮肤病和炎症。然而，在现实世界中，它与血栓栓塞的关系尚不清楚。在本研究中，我们旨在评估这种关联。患者和方法：我们从2004年第一季度至2020年第三季度的日本不良药物事件报告数据库中收集数据，并进行报告优势比分析和多因素logistic回归分析。结果：总共分析了1,735,923份报告。54例静脉血栓栓塞（VTE）和8例动脉血栓栓塞疑似为TXA所致。检测到静脉血栓栓塞的显著信号(报告优势比=6.61；95%可信区间=5.03-8.70)，但动脉血栓栓塞不适用。涉及TXA的静脉血栓栓塞病例在女性和体重指数≥25的个体中比在其他组中更常见。结论：TXA可能与静脉血栓栓塞有关。研究结果强调了在给药期间仔细监测患者的重要性，特别是在高危人群中，如女性和超重个体。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

In vivo 医学-医学：研究与实验

CiteScore

4.20

自引率

4.30%

发文量

330

审稿时长

3-8 weeks

期刊介绍： IN VIVO is an international peer-reviewed journal designed to bring together original high quality works and reviews on experimental and clinical biomedical research within the frames of physiology, pathology and disease management. The topics of IN VIVO include: 1. Experimental development and application of new diagnostic and therapeutic procedures; 2. Pharmacological and toxicological evaluation of new drugs, drug combinations and drug delivery systems; 3. Clinical trials; 4. Development and characterization of models of biomedical research; 5. Cancer diagnosis and treatment; 6. Immunotherapy and vaccines; 7. Radiotherapy, Imaging; 8. Tissue engineering, Regenerative medicine; 9. Carcinogenesis.