Abstract:
The anticoagulation effect of heparin requires adequate serum antithrombin (AT)-III levels. Rivaroxaban, however, exhibits its anticoagulation effects independent of AT-III. The aim of the present study was to evaluate the efficacy and safety of rivaroxaban as a treatment for venous thromboembolism in patients with AT-III deficiency due to nephrotic syndrome. Patients with nephrotic syndrome and low serum concentration and functional activity of AT-III and venous thromboembolism were randomly assigned to the rivaroxaban group (n=8) and low weight molecular heparin group (n=8). The patients were treated for 4 weeks and evaluated at weeks 2 and 4. The primary endpoint was thrombus dissolution or a >90% decrease in thrombus volume in 4 weeks. Secondary endpoints included an increase in the volume of the pre-existing thrombosis and safety assessments. In each of the two groups, 7/8 patients achieved a primary endpoint. At week 2, 5 patients in the rivaroxaban group and 4 in the low weight molecular heparin group had achieved the primary endpoint. Notably, at week 2 the patients whose AT-III levels and functional activity remained low in the low weight molecular heparin group did not achieve the primary endpoint. The adverse effects were similar in both groups, with no severe hemorrhage observed. In conclusion, the results of this pilot study demonstrate that rivaroxaban may be an effective, safe, single-agent approach for treating vein thromboembolism in patients with nephrotic syndrome and low AT-III levels. The potential benefits of rivaroxaban over low weight molecular heparin treatment require further investigation with a larger sample size in order to validate the findings of the present study.
摘要:
肝素的抗凝作用需要足够的血清抗凝血酶(AT)-III水平。利伐沙班,然而,表现出其独立于AT-III的抗凝作用。本研究的目的是评估利伐沙班作为肾病综合征引起的AT-III缺乏症患者静脉血栓栓塞的疗效和安全性。将肾病综合征,AT-III的血清浓度和功能活性低以及静脉血栓栓塞症的患者随机分为利伐沙班组(n=8)和低分子肝素组(n=8)。患者治疗4周,并在第2周和第4周进行评估。主要终点为血栓溶解或4周内血栓体积减少>90%。次要终点包括预先存在的血栓形成和安全性评估的体积增加。在两组中,7/8患者达到主要终点。在第2周,利伐沙班组的5例患者和低分子量肝素组的4例患者达到了主要终点。值得注意的是,第2周时,低分子肝素组AT-III水平和功能活性仍然较低的患者未达到主要终点.两组的不良反应相似,未观察到严重出血。总之,这项初步研究的结果表明,利伐沙班可能是一种有效的,安全,单药治疗肾病综合征和低AT-III水平患者的静脉血栓栓塞症。利伐沙班相对于低分子量肝素治疗的潜在益处需要用更大的样本量进行进一步研究,以验证本研究的结果。