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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.

DOI:10.1177/2042098617742344
PMID:29318007
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5753995/
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。

相似文献

1
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.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
Ther Adv Drug Saf. 2018 Jan;9(1):89-91. doi: 10.1177/2042098617742344. Epub 2017 Nov 23.
2
Idarucizumab, a Specific Reversal Agent for Dabigatran: Mode of Action, Pharmacokinetics and Pharmacodynamics, and Safety and Efficacy in Phase 1 Subjects.依达赛珠单抗,一种达比加群的特异性逆转剂:作用机制、药代动力学和药效学以及1期受试者的安全性和有效性。
Am J Med. 2016 Nov;129(11S):S64-S72. doi: 10.1016/j.amjmed.2016.06.007. Epub 2016 Aug 26.
3
[Treatment with inhibitors of new oral direct anticoagulants in patients with severe bleedings or urgent surgical procedures. The new dabigatran antidote: the place of idarucizumab in clinical practice].[新型口服直接抗凝剂抑制剂在严重出血或紧急外科手术患者中的治疗。新型达比加群解毒剂:依达赛珠单抗在临床实践中的地位]
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Idarucizumab, a specific reversal agent for dabigatran: mode of action, pharmacokinetics and pharmacodynamics, and safety and efficacy in phase 1 subjects.依达赛珠单抗,一种达比加群的特异性逆转剂:作用机制、药代动力学和药效学,以及在1期受试者中的安全性和有效性。
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Reversal of dabigatran-associated bleeding using idarucizumab: review of the current evidence.达比加群相关出血的逆转药物idarucizumab:当前证据回顾。
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Idarucizumab for Reversal of Dabigatran-Associated Bleeding: Misnomer or Miracle?艾达赛珠单抗用于逆转达比加群相关出血:用词不当还是奇迹?
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Specific antidotes against direct oral anticoagulants: A comprehensive review of clinical trials data.直接口服抗凝剂的特异性解毒剂:临床试验数据的全面综述
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Reversal strategies in patients treated with direct oral anticoagulants.接受直接口服抗凝剂治疗患者的逆转策略。
Vasa. 2019 Aug;48(5):389-392. doi: 10.1024/0301-1526/a000777. Epub 2019 Feb 5.

本文引用的文献

1
Reversing anticoagulant effects of novel oral anticoagulants: role of ciraparantag, andexanet alfa, and idarucizumab.逆转新型口服抗凝药的抗凝作用:环帕兰特、安多凝血素α及依达赛珠单抗的作用
Vasc Health Risk Manag. 2016 Feb 17;12:35-44. doi: 10.2147/VHRM.S89130. eCollection 2016.
2
Risk of bleeding with dabigatran in atrial fibrillation.达比加群酯在心房颤动中的出血风险。
JAMA Intern Med. 2015 Jan;175(1):18-24. doi: 10.1001/jamainternmed.2014.5398.
3
The impact of bleeding complications in patients receiving target-specific oral anticoagulants: a systematic review and meta-analysis.目标特异性口服抗凝剂治疗患者出血并发症的影响:系统评价和荟萃分析。
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4
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5
A comparison of results of the US food and drug administration's mini-sentinel program with randomized clinical trials: the case of gastrointestinal tract bleeding with dabigatran.美国食品药品监督管理局微型哨点计划结果与随机临床试验的比较:达比加群所致胃肠道出血的案例
JAMA Intern Med. 2014 Jan;174(1):150-1. doi: 10.1001/jamainternmed.2013.12217.
6
The acute management of haemorrhage, surgery and overdose in patients receiving dabigatran.达比加群酯治疗患者的出血、手术和过量的急性处理。
Emerg Med J. 2014 Feb;31(2):163-8. doi: 10.1136/emermed-2012-201976. Epub 2013 Feb 22.
7
The RE-LY study: Randomized Evaluation of Long-term anticoagulant therapY: dabigatran vs. warfarin.
Eur Heart J. 2009 Nov;30(21):2554-5. doi: 10.1093/eurheartj/ehp384. Epub 2009 Sep 21.