Gerinnungszentrum Rhein Ruhr, Duisburg, North Rhine-Westphalia, Germany.
Department of Paediatrics and Adolescent Medicine, Medical University of Vienna, Wien, Austria.
Hamostaseologie. 2022 Apr;42(2):123-130. doi: 10.1055/a-1740-7080. Epub 2022 Apr 29.
Thrombotic events are an increasing challenge in pediatrics. Standard-of-care anticoagulants for pediatric thrombosis have several disadvantages which could be overcome by using direct oral anticoagulants (DOACs). Until recently, there was not enough evidence from clinical trials to recommend for or against the use of any of the four DOACs in children with thrombosis. In this literature review, we looked at the latest clinical trials in this field. On clinicaltrials.gov, we found 13 current studies with published results. For two of the four DOACs, namely dabigatran and rivaroxaban, we found successful phase III studies which led to the approval for the use in children. The results of these pivotal phase III studies allow to finally recommend rivaroxaban and dabigatran for the prophylaxis and treatment of thrombotic events in children.
血栓事件是儿科领域日益严峻的挑战。标准的儿科血栓症抗凝治疗存在多种不足,而使用直接口服抗凝剂(DOAC)可克服这些不足。直到最近,仍缺乏足够的临床试验证据来推荐或反对在患有血栓症的儿童中使用任何 4 种 DOAC 之一。在本次文献回顾中,我们查看了该领域的最新临床试验。在 clinicaltrials.gov 上,我们发现了 13 项具有已发表结果的当前研究。对于其中两种 DOAC,即达比加群和利伐沙班,我们发现了成功的 III 期研究,这为在儿童中使用这两种药物铺平了道路。这些关键的 III 期研究结果最终允许推荐利伐沙班和达比加群用于儿童血栓事件的预防和治疗。