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一项前瞻性随机对照研究,以确定利伐沙班的合适给药期,预防全膝关节置换术患者深静脉血栓形成。

A prospective randomized comparative study to determine appropriate edoxaban administration period, to prevent deep vein thromboembolism in patients with total knee arthroplasty.

作者信息

Ishida Kazunari, Shibanuma Nao, Kodato Kazuki, Toda Akihiko, Sasaki Hiroshi, Takayama Koji, Hayashi Shinya, Hashimoto Shingo, Matsushita Takehiko, Niikura Takahiro, Kurosaka Masahiro, Kuroda Ryosuke, Matsumoto Tomoyuki

机构信息

Department of Orthopaedic Surgery, Kobe Kaisei Hospital, 3-11-15, Shinohara-Kita, Nada, Kobe, 657-0068, Japan.

Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, 7-5-1, Kusunoki, Chuo, Kobe, 650-0017, Japan.

出版信息

J Orthop Sci. 2018 Nov;23(6):1005-1010. doi: 10.1016/j.jos.2018.06.004. Epub 2018 Jul 4.

Abstract

BACKGROUND

This study aimed to determine the appropriate administration duration of edoxaban 15 mg (a factor Xa inhibitor) for the prevention of deep vein thrombosis (DVT) after total knee arthroplasty (TKA).

METHODS

Our study comprised 202 patients who underwent TKA (excluding bilateral TKA) at our institution between 2014 and 2015. The subjects received edoxaban 15 mg daily for 1 (n = 93) or 2 (n = 109) weeks; group assignment was random. B-mode ultrasonography was performed 7 and 14 days post-TKA for the detection of DVT. We compared the incidence of DVT between the groups and examined for side effects.

RESULTS

The demographic data of the patients in the 1- and 2-week administration groups were similar at baseline. DVT incidence did not differ significantly between the groups at 1 week post-TKA. However, it was significantly lower in the 2-week administration group (n = 0) than in the 1-week administration group (n = 7; p = 0.004) at 2 weeks post-DVT. Neither group exhibited symptomatic DVT. A total of six patients withdrew during the study period because of hepatic dysfunction.

CONCLUSIONS

Our results show that the administration of edoxaban 15 mg is more effective in preventing DVT after TKA when administered for 2 weeks than for 1 week.

摘要

背景

本研究旨在确定15毫克依度沙班(一种Xa因子抑制剂)预防全膝关节置换术(TKA)后深静脉血栓形成(DVT)的合适给药持续时间。

方法

我们的研究纳入了2014年至2015年期间在我院接受TKA(不包括双侧TKA)的202例患者。受试者随机接受15毫克依度沙班每日给药,持续1周(n = 93)或2周(n = 109)。TKA术后7天和14天进行B型超声检查以检测DVT。我们比较了两组之间DVT的发生率,并检查了副作用。

结果

1周和2周给药组患者的人口统计学数据在基线时相似。TKA术后1周时,两组之间的DVT发生率无显著差异。然而,在DVT术后2周时,2周给药组(n = 0)的发生率显著低于1周给药组(n = 7;p = 0.004)。两组均未出现有症状的DVT。在研究期间,共有6例患者因肝功能障碍退出。

结论

我们的结果表明,TKA术后预防DVT时,15毫克依度沙班给药2周比给药1周更有效。

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