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首页> 外文期刊>Journal of Clinical Medicine Research >A Case of a Reversible Neurologic Adverse Reaction to Apixaban Confirmed by Re-Challenge
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A Case of a Reversible Neurologic Adverse Reaction to Apixaban Confirmed by Re-Challenge

机译:再挑战证实对阿哌沙班的神经可逆性不良反应一例

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Post-marketing reporting of adverse drug events is essential for new medications, as pre-FDA approval studies lack sufficient subject numbers to detect signals for rare events. Prescriptions for the novel oral anticoagulant factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) have equaled or exceeded those for vitamin K antagonists in many clinical settings requiring chronic anticoagulation, and those of injectable heparins for deep vein thrombosis prophylaxis. We report the case of a 60-year-old woman followed for permanent atrial fibrillation who was prescribed apixaban. She rapidly developed worsening neurologic symptoms of imbalance and non-vertiginous dizziness preventing her from walking, headache, diplopia, and confusion/disorientation. Her symptoms began to resolve after stopping the drug, with return to baseline function within 72 h. Unbeknownst to her cardiology care team, the patient chose to re-challenge herself with apixaban at the same dose, producing identical symptoms and again total symptom resolution within 24 h of drug discontinuation. When seen by her physician, her physical examination was unchanged from her pre-treatment baseline. Symptoms did not recur when switched to rivaroxaban therapy.J Clin Med Res. 2018;10(6):523-526doi: https://doi.org/10.14740/jocmr3394w.
机译:不良药物事件的上市后报告对于新药至关重要,因为FDA之前的批准研究缺乏足够的受试者人数来检测罕见事件的信号。在许多需要长期抗凝的临床环境中,新型口服抗凝因子Xa抑制剂(利伐沙班,阿哌沙班,依多沙班)的处方已等于或超过维生素K拮抗剂的处方,以及预防深静脉血栓形成的可注射肝素的处方。我们报道了一名60岁的女性,该患者因处方阿哌沙班而遭受永久性心房颤动。她迅速发展出严重的神经失调症状,即不平衡和非自然眩晕,从而无法行走,头痛,复视和神志不清。停药后她的症状开始缓解,并在72小时内恢复基线功能。对于她的心脏病护理团队不为人所知,患者选择以相同剂量再次用apixaban挑战自己,产生相同的症状,并在停药后24小时内再次完全缓解症状。当由她的医师看时,她的身体检查与治疗前的基线没有变化。改用利伐沙班治疗后症状没有复发。 2018; 10(6):523-526doi:https://doi.org/10.14740/jocmr3394w。

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