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利伐沙班治疗肾病综合征合并低抗凝血酶III患者的静脉血栓栓塞:一项初步研究。

Rivaroxaban for the treatment of venous thromboembolism in patients with nephrotic syndrome and low AT-III: A pilot study.

作者信息

Zhang Lihua, Zhang Haitao, Zhang Jiong, Tian Hong, Liang Ju, Liu Zhihong

机构信息

National Clinical Research Center of Kidney Disease, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu 210016, P.R. China.

出版信息

Exp Ther Med. 2018 Jan;15(1):739-744. doi: 10.3892/etm.2017.5471. Epub 2017 Nov 8.

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。然而,利伐沙班的抗凝作用独立于AT-III。本研究的目的是评估利伐沙班治疗肾病综合征所致AT-III缺乏患者静脉血栓栓塞的疗效和安全性。将患有肾病综合征且血清AT-III浓度和功能活性低以及静脉血栓栓塞的患者随机分为利伐沙班组(n = 8)和低分子量肝素组(n = 8)。患者接受治疗4周,并在第2周和第4周进行评估。主要终点是4周内血栓溶解或血栓体积减少>90%。次要终点包括原有血栓体积增加和安全性评估。在两组中,每组8例患者中有7例达到主要终点。在第2周时,利伐沙班组有5例患者、低分子量肝素组有4例患者达到主要终点。值得注意的是,在第2周时,低分子量肝素组中AT-III水平和功能活性仍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,利伐沙班可能是治疗肾病综合征且AT-III水平低的患者静脉血栓栓塞的一种有效、安全的单药治疗方法。与低分子量肝素治疗相比,利伐沙班的潜在益处需要通过更大样本量的进一步研究来验证本研究的结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ec1/5772665/c32134701750/etm-15-01-0739-g00.jpg

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