Bui My Hanh, Son Nguyen Truong, Viet Pham Thanh, Hiep Nguyen Hoang, Dinh Toi Chu
Tuberculosis and Lung Disease Department, Hanoi Medical University, Hanoi, Vietnam.
Scientific Research & International Cooperation Department, Hanoi Medical University Hospital, Hanoi, Vietnam.
Open Access Maced J Med Sci. 2019 Dec 20;7(24):4255-4259. doi: 10.3889/oamjms.2019.370. eCollection 2019 Dec 30.
Direct oral anticoagulant-rivaroxaban may provide a simple, fixed-dose therapy for the management of hospital-acquired, acute venous thromboembolism (VTE) and for extended treatment, its use could skip lab observation and/or parenteral treatment.
Compare the efficacy and safety (EAS) of RIV vs. standard therapy (SDTD) in a cohort of Vietnamese patients diagnosed with symptomatic, acute VTE.
An open-label, case-control, prospective study was conducted to check the efficacy and safety (EAS) of oral rivaroxaban (RIV) alone (15 mg 2 times/day for 3 weeks, then 20 mg 1 time/day) in a comparison to the standard therapy (STDT) (enoxaparin 1.0 mg/kg 2 times/day combining with vitamin K antagonist). Patients were treated for 6 months and followed-up for suspect reoccurring VTE and bleeding.
A total 187 patients were enrolled into study. 83 were provided rivaroxaban and 104 received enoxaparin overlapping with vitamin K antagonist (VKAs). Recurrent VTE occurred in 3 (3.6%) rivaroxaban-received patients compared with 5 (4.8%) standard-treatment received patients (OR: 0.74, 95% CI, 0.17 to 3.20, p > 0.05). Major bleeding events were found in 1 (1,8%) and 4 (3.9%) cases in the RIV treated and STDT cohort, respectively (OR: 0.30, 95% CI, 0.03 to 2.76, p > 0.05).
The finding of this study in Vietnamese patients with acute VTE presented comparable EAS profile with RIV versus STDT, consistent with those found in global population.
直接口服抗凝药利伐沙班可为医院获得性急性静脉血栓栓塞症（VTE）的管理提供一种简单的固定剂量疗法，并且在延长治疗中，其使用可无需实验室监测和/或肠外治疗。
比较利伐沙班（RIV）与标准疗法（SDTD）在一组诊断为有症状急性VTE的越南患者中的疗效和安全性（EAS）。
开展一项开放标签、病例对照、前瞻性研究，以检查单独口服利伐沙班（RIV）（15毫克，每日2次，共3周，然后20毫克，每日1次）与标准疗法（STDT）（依诺肝素1.0毫克/千克，每日2次联合维生素K拮抗剂）相比的疗效和安全性（EAS）。患者接受6个月治疗，并对疑似复发性VTE和出血进行随访。
共有187例患者纳入研究。83例接受利伐沙班治疗，104例接受依诺肝素与维生素K拮抗剂（VKAs）重叠治疗。接受利伐沙班治疗的患者中有3例（3.6%）发生复发性VTE，而接受标准治疗的患者中有5例（4.8%）发生复发性VTE（比值比：0.74，95%置信区间，0.17至3.20，p>0.05）。在RIV治疗组和STDT队列中，分别有1例（1.8%）和4例（3.9%）发生大出血事件（比值比：0.30，95%置信区间，0.03至2.76，p>0.05）。
本研究在越南急性VTE患者中的发现表明，RIV与STDT的疗效和安全性概况具有可比性，与全球人群中的发现一致。
