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全膝关节置换术后药物预防静脉血栓栓塞症的有效性和安全性比较。

Comparative Effectiveness and Safety of Drug Prophylaxis for Prevention of Venous Thromboembolism After Total Knee Arthroplasty.

机构信息

Surgical Outcomes and Analysis, Kaiser Permanente, San Diego, California.

College of Pharmacy, Western University of Health Sciences, Pomona, California.

出版信息

J Arthroplasty. 2017 Nov;32(11):3524-3528.e1. doi: 10.1016/j.arth.2017.05.042. Epub 2017 May 31.

Abstract

BACKGROUND

Rates of venous thromboembolism in contemporary studies of primary total knee arthroplasty (TKA) have been reported to be as high as 3.5%. Although drug prophylaxis is effective, the best option among these regimens is not well established. The purpose of this study was to evaluate the comparative effectiveness and safety of aspirin, low-molecular-weight heparin, synthetic pentasaccharide factor Xa inhibitors, and vitamin K antagonist.

METHODS

Data were from a US total joint replacement registry, with 30,499 patients receiving unilateral TKA from May 16, 2006, to December 31, 2013. Patients received either aspirin (324-325 mg daily), enoxaparin (40-60 mg daily), fondaparinux (2.5 mg daily), or warfarin (all doses) and were followed up 90 days postoperatively on several outcomes: deep vein thrombosis, pulmonary embolism, major bleeding, wound complications, infection, and death.

RESULTS

There was no evidence that fondaparinux, enoxaparin, or warfarin were superior to aspirin in the prevention of pulmonary embolism, deep vein thrombosis, or venous thromboembolism or that aspirin was safer than these alternatives. However, enoxaparin was found to be as safe as aspirin with respect to bleeding, and fondaparinux was as safe as aspirin for risk of wound complications.

CONCLUSION

Among TKA patients, we did not find evidence for decreased effectiveness or increased safety with use of aspirin, but enoxaparin had comparable safety to aspirin for bleeding and fondaparinux had comparable safety to aspirin for wound complications.

摘要

背景

在当代初次全膝关节置换术(TKA)的研究中,静脉血栓栓塞的发生率高达 3.5%。尽管药物预防是有效的,但这些方案中哪种是最佳选择尚未确定。本研究旨在评估阿司匹林、低分子肝素、合成五肽 Xa 因子抑制剂和维生素 K 拮抗剂的相对有效性和安全性。

方法

数据来自美国关节置换登记处,共有 30499 例患者于 2006 年 5 月 16 日至 2013 年 12 月 31 日接受单侧 TKA。患者接受阿司匹林(324-325mg 每日)、依诺肝素(40-60mg 每日)、磺达肝癸钠(2.5mg 每日)或华法林(所有剂量)治疗,并在术后 90 天随访以下结局:深静脉血栓形成、肺栓塞、大出血、伤口并发症、感染和死亡。

结果

没有证据表明磺达肝癸钠、依诺肝素或华法林在预防肺栓塞、深静脉血栓形成或静脉血栓栓塞方面优于阿司匹林,也没有证据表明阿司匹林比这些替代药物更安全。然而,依诺肝素在出血方面与阿司匹林一样安全,磺达肝癸钠在伤口并发症方面与阿司匹林一样安全。

结论

在 TKA 患者中,我们没有发现阿司匹林的有效性降低或安全性增加的证据,但依诺肝素在出血方面与阿司匹林安全性相当,磺达肝癸钠在伤口并发症方面与阿司匹林安全性相当。

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