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在低发人群中,髋关节置换术后使用利伐沙班与阿司匹林进行血栓预防的临床结局和危险因素:一项来自韩国的全国性研究。

Clinical outcomes and risk factors of thromboprophylaxis with rivaroxaban versus aspirin in patients undergoing hip arthroplasty in low-incidence population: A nationwide study in Korea.

机构信息

Division of Life and Pharmaceutical Sciences Graduate School, Ewha Womans University, Seoul, Republic of Korea.

College of Pharmacy, Seoul National University, Seoul, Republic of Korea.

出版信息

Pharmacoepidemiol Drug Saf. 2019 Apr;28(4):507-514. doi: 10.1002/pds.4737. Epub 2019 Mar 7.

Abstract

PURPOSE

We aimed to evaluate the efficacy and safety of rivaroxaban in thromboprophylaxis compared with those of aspirin in real-world patients who underwent hip arthroplasty using nationwide claims data.

METHODS

Patients aged more than or equal to 18 years with at least one hip arthroplasty including total and partial hip replacements and hip replacement revisions during July 2009 to June 2013 were identified from the Health Insurance Review and Assessment (HIRA) database. The study outcome was incidence rate of thromboembolic events and anticoagulation-related major bleeding within 90 days of hip arthroplasty.

RESULTS

The incidence of overall venous thromboembolism (VTE) within 90-day postsurgery was significantly higher in the aspirin cohort than it was in the rivaroxaban cohorts. Bleeding events associated with pharmacological thromboprophylaxis in patients who received rivaroxaban were not significantly different from that in aspirin-treated patients. In aspirin cohorts, 65.7% of patients received less than 3-week treatment while about half received a less than 14-day treatment, and 31.7% received more than 3-week treatment in the rivaroxaban cohort.

CONCLUSIONS

This study demonstrates that rivaroxaban was more effective in preventing VTE following hip arthroplasty without raising bleeding risks in clinical settings. Age more than or equal to 80 years, women, and a history of thromboembolism were the risk factors of VTE incidence.

摘要

目的

我们旨在使用全国性理赔数据,评估利伐沙班在髋关节置换术后患者中的抗血栓形成预防效果和安全性,与阿司匹林进行比较。

方法

从健康保险审查和评估(HIRA)数据库中,筛选出 2009 年 7 月至 2013 年 6 月期间至少接受过一次髋关节置换术(包括全髋关节置换术和部分髋关节置换术以及髋关节置换术翻修术)的年龄≥18 岁的患者。研究结局为髋关节置换术后 90 天内血栓栓塞事件和抗凝相关大出血的发生率。

结果

术后 90 天内,总体静脉血栓栓塞症(VTE)的发生率在阿司匹林组中明显高于利伐沙班组。接受利伐沙班治疗的患者与接受阿司匹林治疗的患者相比,药物性血栓预防相关出血事件没有显著差异。在阿司匹林组中,65.7%的患者接受的治疗少于 3 周,约一半患者接受的治疗少于 14 天,而利伐沙班组中 31.7%的患者接受的治疗超过 3 周。

结论

本研究表明,利伐沙班在髋关节置换术后更有效地预防 VTE,且不会增加出血风险。80 岁及以上、女性和血栓栓塞史是 VTE 发生率的危险因素。

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