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低分子量肝素与华法林及口服Xa因子抑制剂预防肿瘤患者复发性静脉血栓栓塞的回顾性比较:Re-CLOT研究

Retrospective comparison of low molecular weight heparin vs. warfarin vs. oral Xa inhibitors for the prevention of recurrent venous thromboembolism in oncology patients: The Re-CLOT study.

作者信息

Alzghari Saeed K, Seago Susan E, Garza Jessica E, Hashimie Yasmeen F, Baty Kimberly A, Evans Martha F, Shaver Courtney, Herrington Jon D

机构信息

1 Department of Pharmacy, Scott & White Medical Center - Temple, Baylor Scott & White Health, USA.

2 Department of Medicine, Scott & White Medical Center - Temple, Baylor Scott & White Health, USA.

出版信息

J Oncol Pharm Pract. 2018 Oct;24(7):494-500. doi: 10.1177/1078155217718382. Epub 2017 Jul 16.

Abstract

Background There is increasing evidence indicating oral factor Xa inhibitors can be used for secondary prevention of venous thromboembolism. Studies are needed to compare oral factor Xa inhibitors, low molecular weight heparins, and warfarin in the oncology population. The purpose of this study is to evaluate the recurrent venous thromboembolism incidence in oncology patients utilizing oral Xa inhibitors, low molecular weight heparins, or warfarin. Methods Using retrospectively collected data, we compared the recurrent venous thromboembolism incidence in oncology patients taking rivaroxaban/apixaban, enoxaparin, or warfarin with at least three months of follow-up. Patients were included if they had an active cancer, venous thromboembolism, and taking warfarin, enoxaparin, or rivaroxaban/apixaban. The primary endpoint was the first episode of recurrent venous thromboembolism at three months. Secondary endpoints included recurrent venous thromboembolism after six months, major bleeding, and mortality. Results Of 127 venous thromboembolism patients, 48 received rivaroxaban or apixaban, 23 received enoxaparin, and 56 received warfarin. The three most common cancer diagnoses were lung (21%), colorectal (14%), and breast (14%). There was no difference in venous thromboembolism recurrence at three months between the rivaroxaban/apixaban (0%), warfarin (3.6%), and the enoxaparin cohorts (4.4%) (p = 0.8319). Major bleeding at three months was only seen in one patient in the enoxaparin arm (4.2%). Mortality at three months was 0%, 3.6%, and 17.4% in the rivaroxaban/apixaban, warfarin, and enoxaparin cohorts, respectively. Conclusion The results of this retrospective study suggest that oral factor Xa inhibitors are potential options for cancer patients with venous thromboembolism. However, randomized, controlled trials are needed to confirm these results.

摘要

背景 越来越多的证据表明口服Xa因子抑制剂可用于静脉血栓栓塞的二级预防。需要开展研究以比较口服Xa因子抑制剂、低分子肝素和华法林在肿瘤患者中的应用情况。本研究的目的是评估使用口服Xa抑制剂、低分子肝素或华法林的肿瘤患者复发性静脉血栓栓塞的发生率。方法 利用回顾性收集的数据,我们比较了接受利伐沙班/阿哌沙班、依诺肝素或华法林治疗且随访至少3个月的肿瘤患者复发性静脉血栓栓塞的发生率。纳入标准为患有活动性癌症、静脉血栓栓塞且正在服用华法林、依诺肝素或利伐沙班/阿哌沙班的患者。主要终点是3个月时复发性静脉血栓栓塞的首次发作。次要终点包括6个月后的复发性静脉血栓栓塞、大出血和死亡率。结果 在127例静脉血栓栓塞患者中,48例接受利伐沙班或阿哌沙班治疗,23例接受依诺肝素治疗,56例接受华法林治疗。三种最常见的癌症诊断为肺癌(21%)、结直肠癌(14%)和乳腺癌(14%)。利伐沙班/阿哌沙班组(0%)、华法林组(3.6%)和依诺肝素组(4.4%)在3个月时静脉血栓栓塞复发率无差异(p = 0.8319)。3个月时大出血仅在依诺肝素组的1例患者中出现(4.2%)。利伐沙班/阿哌沙班组、华法林组和依诺肝素组3个月时的死亡率分别为0%、3.6%和17.4%。结论 这项回顾性研究的结果表明,口服Xa因子抑制剂是患有静脉血栓栓塞的癌症患者的潜在选择。然而,需要进行随机对照试验来证实这些结果。

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