Lee Lai Heng
Department of Haematology, Singapore General Hospital, 20, College Road, Academia Level 3, Singapore, 169856 Singapore.
Thromb J. 2016 Oct 4;14(Suppl 1):17. doi: 10.1186/s12959-016-0111-3. eCollection 2016.
The group of new oral anticoagulants or NOACs, now termed direct oral anticoagulants or DOACs, with their favourable results from large scale phase III clinical trials, represent a major advancement and expanded armamentarium in antithrombotic therapy. Dabigatran, rivaroxaban, apixaban and edoxaban are now in clinical routine use for prevention and treatment of arterial and venous thrombotic diseases as addressed in their clinical trials. Usage of the DOACs is expected to increase as clinicians gain more experience and reassurance with data from the real world studies which are generally consistent with that from clinical trials. Development of specific antidotes in management of bleeding complications and development of coagulation assays for their plasma levels will further boost the confidence in the DOACs. Nonetheless, there are still limitations associated with the DOACs. Many patients in need of anticoagulant therapy for indications not studied in the clinical trials will not be eligible for treatment with a DOAC. Conditions where more data is required include DOACs use in the paediatric age group, patients with atrial fibrillation and valvular heart disease, thrombosis associated with the anti-phospholipid syndrome and cancer associated thrombosis. The affordability and access to these drugs may pose an issue for many patients under healthcare systems not providing for these medications. With four new anticoagulants coming onboard very quickly, the focus has shifted to the practical approach and management in real life as many clinicians are not yet familiar with the DOACs. Clinicians need to be educated on how to manage this new class for drugs, from choosing the appropriate drug to prevention and managing bleeding complications as a lack of knowledge and understanding in these drugs will lead to inappropriate use and compromise on patient safety.
新一代口服抗凝药(NOACs),现称为直接口服抗凝药(DOACs),凭借大规模III期临床试验的良好结果,成为抗栓治疗领域的一项重大进展,并扩充了药物储备。达比加群、利伐沙班、阿哌沙班和依度沙班目前已在临床常规用于预防和治疗动脉及静脉血栓性疾病,这在其临床试验中已有阐述。随着临床医生从与临床试验数据总体一致的真实世界研究中获得更多经验并更加安心,DOACs的使用预计将会增加。开发针对出血并发症处理的特异性解毒剂以及针对其血浆水平的凝血检测方法,将进一步增强对DOACs的信心。尽管如此,DOACs仍存在局限性。许多因临床试验未研究的适应症而需要抗凝治疗的患者不符合使用DOACs进行治疗的条件。需要更多数据的情况包括DOACs在儿童年龄组、心房颤动和瓣膜性心脏病患者、抗磷脂综合征相关血栓形成以及癌症相关血栓形成中的应用。对于许多在医疗保健系统中无法获得这些药物的患者来说,这些药物的可承受性和可及性可能成为一个问题。随着四种新型抗凝药迅速上市,由于许多临床医生对DOACs尚不熟悉,关注点已转向现实生活中的实际应用和管理。临床医生需要接受关于如何管理这类新药的培训,从选择合适的药物到预防和处理出血并发症,因为对这些药物缺乏了解将导致使用不当并危及患者安全。