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低剂量NOACs在非瓣膜性房颤患者中的有效性和安全性研究

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目的 通过考察真实世界非瓣膜性房颤(non-valvular atrial fibrillation,NVAF)患者使用低剂量非维生素K拮抗剂口服抗凝药(Non-vitamin K antagonist oral anticoagulants,NOACs)的临床结果,为NVAF患者应用NOACs提供更多的参考和依据,促进其临床合理使用。方法 纳入 2020 年 1 月~2022 年 4 月徐州医科大学附属医院使用NOACs抗凝治疗的NVAF患者,比较使用低剂量NOACs治疗的患者和按照说明书推荐剂量治疗的患者 12 个月内缺血性卒中/全身性栓塞事件(ischemic stroke/systemic embolism,IS/SE)、出血事件的发生率及全因死亡率。结果 在 419 例NVAF患者中,286 例患者使用低剂量NOACs(68。3%),其中利伐沙班为 201 例(48。0%),达比加群为85 例(20。3%)。多因素Logistic回归结果显示,与推荐剂量治疗相比,使用低剂量NOACs患者发生IS/SE风险显著增加(OR:7。42;95%CI:1。50~36。70)、但两组出血事件发生率和全因死亡率差异无统计学意义(P>0。05)。结论 使用低剂量NOACs可能会增加NVAF患者血栓栓塞的风险,且未降低预期的出血风险,为保证抗凝治疗的有效性和安全性,应谨慎超说明书使用低剂量NOACs。
Study on the effectiveness and safety of under-dosing NOACs in non-valvular atrial fibrillation patients
Objective To investigate the clinical results of under-dosing non-Vitamin K antagonist oral anticoagulants(NOACs)used by patients with non valvular atrial fibrillation(NVAF)in the real world,so as to provide more reference and basis for the use of NOACs in NVAF patients and promote their clinical rational use.Methods Patients with NVAF treated with NOACs in the Affiliated Hospital of Xuzhou Medical University from January 2020 to April 2022 were included.The incidence of ischemic stroke/systemic embolism(IS/SE),bleeding events and all-cause mortality within 12 months were compared between patients treated with under-dosing NOACs and who with the dose recommended in the instruction manual(on-label dosing).Results Among 419 NVAF patients,286 patients used under-dosing NOACs(68.3%),of whom 201(48.0%)were Rivaroxaban and 85(20.3%)were Dabigatran.The results of multivariate Logistic regression showed that compared to on-label dosing,under-dosing was associated with a higher risk of IS/SE(OR:7.42;95%CI:1.50~36.70),and there was no significant difference in the incidence of bleeding events and all-cause mortality(P>0.05).Conclusion The use of under-dosing NOACs may increase the risk of thromboembolism in NVAF patients,but can't reduce the expected risk of bleeding.To ensure the effectiveness and safety of anticoagulation therapy,caution should be done in using off-label under-dosing NOACs.

Non valvular atrial fibrillationNon-vitamin K antagonist oral anticoagulantsAnticoagulationBleedingEmbolization

张波、刘煜清、胡晓芹、李承宗

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徐州医科大学附属医院药学部,江苏徐州 221006

徐州医科大学,江苏徐州 221004

徐州医科大学附属医院心血管内科,江苏徐州 221006

非瓣膜性房颤 非维生素K拮抗剂口服抗凝药 抗凝 出血 栓塞

江苏省药学会恒瑞药学课题(2021)

H202127

2024

中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
年,卷(期):2024.22(4)
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