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低分子肝素治疗非高危静脉血栓栓塞症癌症患者的有效性和安全性:土耳其观察性研究(TREBECA)。

Effectiveness and Safety of LMWH Treatment in Patients With Cancer Diagnosed With Non-High-Risk Venous Thromboembolism: Turkish Observational Study (TREBECA).

作者信息

Ozaslan Ersin, Ozkan Metin, Cicin Irfan, Benekli Mustafa, Kocer Murat, Uysal Mukremin, Oksuzoglu Berna, Isikdogan Abdurrahman, Cubukcu Erdem, Elkiran Emin T, Dane Faysal, Aliustaoglu Mehmet, Sevinc Alper, Karaoglu Aziz, Ulas Arife, Gokoz-Dogu Gamze

机构信息

1 Department of Medical Oncology, Erciyes University, Kayseri, Turkey.

2 Department of Medical Oncology, Trakya University, Edirne, Turkey.

出版信息

Clin Appl Thromb Hemost. 2018 Sep;24(6):973-979. doi: 10.1177/1076029617753538. Epub 2018 Feb 18.

Abstract

We compared the efficacy and safety of low-molecular-weight heparins (LMWHs) in patients with cancer who are at low risk of venous thromboembolism (VTE). Patients were treated by medical oncologists in Turkey at 15 sites, where they were enrolled and followed up for a period of 12 months. Due to the study design, there was no specific treatment protocol for LMWH. Primary end points were efficacy and the time to change in VTE status. Of the included 250 patients, 239 (95.6%), 176 (70.4%), 130 (52.0%), and 91 (36.4%) completed their day 15, month 3, month 6, and month 12 visits, respectively. Number of patients treated with enoxaparin, bemiparin, and tinzaparin were 133, 112, and 5, respectively. Anticoagulant therapy provoked thrombus resolution in 1.2% and 12.7% of patients using enoxaparin and bemiparin, respectively ( P = .004). Thrombus resolution was observed in 81 more patients at month 3 visit. This ratio was 35 (40.2%) of 87 and 46 (54.1%) of 85 patients administered enoxaparin and bemiparin at the third visit, respectively ( P = .038). Thrombus resolution was observed in 21 more patients during month 6 visit. This ratio was 5 (7.7%) of 65 and 15 (23.4%) of 64 patients administered enoxaparin and bemiparin at the fourth visit, respectively ( P = .022). The LMWH was discontinued in only 2 patients due to gastrointestinal bleeding. This pioneering study shows bemiparin is more effective than enoxaparin in thrombosis resolution and has a similar tolerability profile.

摘要

我们比较了低分子肝素(LMWHs)在静脉血栓栓塞症(VTE)低风险癌症患者中的疗效和安全性。患者由土耳其的15个地点的医学肿瘤学家进行治疗,在这些地点入组并随访12个月。由于研究设计,对于低分子肝素没有特定的治疗方案。主要终点是疗效和VTE状态变化的时间。在纳入的250例患者中,分别有239例(95.6%)、176例(70.4%)、130例(52.0%)和91例(36.4%)完成了第15天、第3个月、第6个月和第12个月的访视。接受依诺肝素、倍他肝素和替扎肝素治疗的患者人数分别为133例、112例和5例。使用依诺肝素和倍他肝素的患者中,分别有1.2%和12.7%的患者抗凝治疗促使血栓溶解(P = 0.004)。在第3个月访视时,又有81例患者观察到血栓溶解。该比例分别为第3次访视时接受依诺肝素治疗的87例患者中的35例(40.2%)和接受倍他肝素治疗的85例患者中的46例(54.1%)(P = 0.038)。在第6个月访视期间,又有21例患者观察到血栓溶解。该比例分别为第4次访视时接受依诺肝素治疗的65例患者中的5例(7.7%)和接受倍他肝素治疗的64例患者中的15例(23.4%)(P = )。仅2例患者因胃肠道出血停用低分子肝素。这项开创性研究表明,倍他肝素在血栓溶解方面比依诺肝素更有效,且具有相似的耐受性。 (注:原文中“P = ”处似乎有误,未给出完整数据)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/630b/6714721/7dd8df7762eb/10.1177_1076029617753538-fig1.jpg

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