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阿哌沙班与利伐沙班导入剂量在静脉血栓栓塞症治疗中的比较效果:多中心观察性真实世界研究

Comparative Effectiveness of Apixaban and Rivaroxaban Lead-in Dosing in VTE Treatment: Observational Multicenter Real-World Study.

作者信息

Alshaya Omar A, Korayem Ghazwa B, Al Yami Majed S, Qudayr Asma H, Althewaibi Sara, Fetyani Lolwa, Alshehri Shaden, Alnashmi Fai, Albasseet Maram, Alshehri Lina, Alhushan Lina M, Almohammed Omar A

机构信息

Department of Pharmacy Practice, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Riyadh 14611, Saudi Arabia.

Pharmaceutical Care Services, King Abdulaziz Medical City, National Guard Health Affairs, Riyadh 11426, Saudi Arabia.

出版信息

J Clin Med. 2022 Dec 27;12(1):199. doi: 10.3390/jcm12010199.

Abstract

Apixaban and rivaroxaban require lead-in dosing for 7 and 21 days, respectively, when treating venous thromboembolism (VTE). However, no evidence exists to support subtracting parenteral anticoagulation days from total lead-in dosing. A multicenter study was conducted, including adult patients with acute VTE who received apixaban or rivaroxaban. The patients were grouped as follows. The recommended group received oral lead-in anticoagulant for the full recommended duration. The mixed group received lead-in therapy as parenteral with oral anticoagulant. The incidence of recurrent VTE (rVTE) and major bleeding (MB) within 90 days were the main outcomes. Of the 368 included patients, 47.8% received apixaban, and 52.2% received rivaroxaban. The recommended lead-in was used in 296 patients (80.4%), whereas 72 (19.6%) received the mixed-lead-in regimen. Five patients had rVTE events within 90 days; two occurred during hospitalization in the recommended group versus none in the mixed group (0.7% vs. 0.0%; = 1.000). After discharge, two events occurred in the recommended group and one in the mixed group (0.7% vs. 1.4%; = 0.481). In terms of MB, 24 events occurred in 21 patients within 90 days. During hospitalization, 11 events occurred in the recommended group and seven in the mixed group (3.7% vs. 9.7%; = 0.060). After discharge, five more events occurred in the recommended group and one in the mixed group (1.4% vs. 1.7%; = 1.000). The mixed-lead-in regimen is safe and effective in comparison with the recommended-lead-in regimen.

摘要

在治疗静脉血栓栓塞症(VTE)时,阿哌沙班和利伐沙班分别需要7天和21天的导入期给药。然而,没有证据支持从总导入期给药天数中减去肠外抗凝天数。进行了一项多中心研究,纳入了接受阿哌沙班或利伐沙班治疗的急性VTE成年患者。患者分组如下。推荐组接受口服导入期抗凝剂的完整推荐疗程。混合组接受肠外与口服抗凝剂联合的导入期治疗。90天内复发性VTE(rVTE)和大出血(MB)的发生率是主要结局。在纳入的368例患者中,47.8%接受阿哌沙班治疗,52.2%接受利伐沙班治疗。296例患者(80.4%)采用了推荐的导入期给药方案,而72例(19.6%)接受了混合导入期给药方案。5例患者在90天内发生rVTE事件;推荐组中有2例在住院期间发生,而混合组中无(0.7%对0.0%;P = 1.000)。出院后,推荐组发生2例事件,混合组发生1例(0.7%对]1.4%;P = 0.481)。在MB方面,90天内21例患者发生了24起事件。住院期间,推荐组发生11起事件,混合组发生7起(3.7%对9.7%;P = 0.060)。出院后,推荐组又发生5起事件,混合组发生1起(1.4%对1.7%;P = 1.000)。与推荐的导入期给药方案相比,混合导入期给药方案安全有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65fe/9821121/f2309117f08c/jcm-12-00199-g001.jpg

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