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三名印度老年患者使用低剂量达比加群后出现下尿路源性严重血尿:新型口服抗凝剂安全性方面的未解决问题

Severe haematuria of lower urinary tract origin with low dose dabigatran use in three Indian elderly patients: unresolved issues in the safety of novel oral anticoagulants.

作者信息

Kaur Upinder, Chakrabarti Sankha Shubhra, Manna Sukdev, Gambhir Indrajeet Singh

机构信息

Department of Pharmacology (Previously Division of Geriatrics, Department of General Medicine), Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.

Division of Geriatrics, Department of General Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, UP, India.

出版信息

Ther Adv Drug Saf. 2018 Jan;9(1):89-91. doi: 10.1177/2042098617742344. Epub 2017 Nov 23.

Abstract

Dabigatran is a newer oral direct thrombin inhibitor approved by the United States Food and Drug Administration and the European Medicines Agency (EMA). The proper dosage of the drug, the potential for adverse drug reactions and the nature of bleeds with use of this drug as with other novel oral anticoagulants (NOACs), in the elderly population are still areas of uncertainty. Despite the existence of a specific antibody, idarucizumab which is an antidote to dabigatran toxicity, management of dabigatran-induced bleeds is an undefined area especially in resource constrained settings. We report severe haematuria with dabigatran in three elderly Indian patients at the lowest recommended therapeutic dose and explore these grey zones in dabigatran therapy.

摘要

达比加群是一种较新的口服直接凝血酶抑制剂,已获美国食品药品监督管理局和欧洲药品管理局(EMA)批准。与其他新型口服抗凝药(NOACs)一样,该药物在老年人群中的适当剂量、药物不良反应的可能性以及使用该药物时出血的性质,仍是不确定的领域。尽管存在一种特异性抗体——idarucizumab(达比加群毒性的解毒剂),但达比加群所致出血的管理仍是一个不明确的领域,尤其是在资源有限的环境中。我们报告了3例印度老年患者在推荐的最低治疗剂量下使用达比加群出现严重血尿的情况,并探讨了达比加群治疗中的这些灰色地带。

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JAMA Intern Med. 2015 Jan;175(1):18-24. doi: 10.1001/jamainternmed.2014.5398.
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