Although rare in children, venous thromboembolism (VTE) is markedly more likely in hospitalized patients, particularly with the use of central venous access devices. Dabigatran etexilate (Pradaxa^®) is one of the first direct non-vitamin K antagonist oral anticoagulants (DOAC) approved for use in pediatric patients. It is approved in the EU and USA for the treatment of VTE in patients who have been treated with a parenteral anticoagulant for ≥ 5 days, and for the prevention of recurrent VTE. In an open-label, phase 2b/3 clinical trial in pediatric patients with acute VTE treated for ≈ 3 months, dabigatran etexilate was non-inferior to standard of care (SOC) treatment for the primary composite endpoint of complete thrombus resolution, freedom from recurrent VTE and VTE-related death. In a single-arm phase 3 safety study, few patients experienced recurrent VTE with ≤ 12 months of anticoagulation with dabigatran etexilate. Dabigatran etexilate was generally well tolerated in both studies; bleeding events were mostly minor and, in the phase 2b/3 study, occurred at a similar incidence to SOC. Although further data will be useful, dabigatran etexilate is a valuable and convenient treatment option in pediatric VTE.

虽然在儿童中很少见，但静脉血栓栓塞 (VTE) 在住院患者中明显更容易发生，尤其是在使用中心静脉通路装置的情况下。达比加群酯（Pradaxa ^®) 是首批获准用于儿科患者的直接非维生素 K 拮抗剂口服抗凝剂 (DOAC) 之一。它在欧盟和美国被批准用于治疗已接受肠外抗凝剂治疗 ≥ 5 天的患者的静脉血栓栓塞，以及预防静脉血栓栓塞复发。在一项针对急性 VTE 儿科患者的开放标签 2b/3 期临床试验中，达比加群酯在血栓完全消退的主要复合终点方面不劣于护理标准 (SOC) 治疗，无复发性 VTE 和 VTE 相关死亡。在一项单臂 3 期安全性研究中，很少有患者在接受达比加群酯抗凝治疗 ≤ 12 个月后出现复发性 VTE。在两项研究中，达比加群酯的耐受性普遍良好；出血事件大多是轻微的，在 2b/3 期研究中，发生率与 SOC 相似。尽管进一步的数据将是有用的，但达比加群酯是儿科 VTE 的一种有价值且方便的治疗选择。