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氨甲环酸在美国全髋关节或膝关节置换术患者中的应用及术后结局:有效性和安全性的回顾性分析

Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety.

作者信息

Poeran Jashvant, Rasul Rehana, Suzuki Suzuko, Danninger Thomas, Mazumdar Madhu, Opperer Mathias, Boettner Friedrich, Memtsoudis Stavros G

机构信息

Institute of Healthcare Delivery Science, Mount Sinai Hospital System / Department of Health Evidence and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Department of Anesthesiology, Hospital for Special Surgery, 535 East 70th Street, New York, NY, USA.

出版信息

BMJ. 2014 Aug 12;349:g4829. doi: 10.1136/bmj.g4829.

Abstract

OBJECTIVE

To determine the effectiveness and safety of perioperative tranexamic acid use in patients undergoing total hip or knee arthroplasty in the United States.

DESIGN

Retrospective cohort study; multilevel multivariable logistic regression models measured the association between tranexamic acid use in the perioperative period and outcomes.

SETTING

510 US hospitals from the claims based Premier Perspective database for 2006-12.

PARTICIPANTS

872,416 patients who had total hip or knee arthroplasty.

INTERVENTION

Perioperative intravenous tranexamic acid use by dose categories (none, ≤ 1000 mg, 2000 mg, and ≥ 3000 mg).

MAIN OUTCOME MEASURES

Allogeneic or autologous transfusion, thromboembolic complications (pulmonary embolism, deep venous thrombosis), acute renal failure, and combined complications (thromboembolic complications, acute renal failure, cerebrovascular events, myocardial infarction, in-hospital mortality).

RESULTS

While comparable regarding average age and comorbidity index, patients receiving tranexamic acid (versus those who did not) showed lower rates of allogeneic or autologous transfusion (7.7% v 20.1%), thromboembolic complications (0.6% v 0.8%), acute renal failure (1.2% v 1.6%), and combined complications (1.9% v 2.6%); all P<0.01. In the multilevel models, tranexamic acid dose categories (versus no tranexamic acid use) were associated with significantly (P<0.001) decreased odds for allogeneic or autologous blood transfusions (odds ratio 0.31 to 0.38 by dose category) and no significantly increased risk for complications: thromboembolic complications (odds ratio 0.85 to 1.02), acute renal failure (0.70 to 1.11), and combined complications (0.75 to 0.98).

CONCLUSIONS

Tranexamic acid was effective in reducing the need for blood transfusions while not increasing the risk of complications, including thromboembolic events and renal failure. Thus our data provide incremental evidence of the potential effectiveness and safety of tranexamic acid in patients requiring orthopedic surgery.

摘要

目的

确定围手术期使用氨甲环酸在美国接受全髋关节或膝关节置换术患者中的有效性和安全性。

设计

回顾性队列研究;多级多变量逻辑回归模型测量围手术期使用氨甲环酸与结局之间的关联。

设置

来自基于2006 - 2012年Premier Perspective数据库索赔的510家美国医院。

参与者

872416例行全髋关节或膝关节置换术的患者。

干预措施

按剂量类别(无、≤1000毫克、2000毫克和≥3000毫克)围手术期静脉使用氨甲环酸。

主要结局指标

异体或自体输血、血栓栓塞并发症(肺栓塞、深静脉血栓形成)、急性肾衰竭以及综合并发症(血栓栓塞并发症、急性肾衰竭、脑血管事件、心肌梗死、住院死亡率)。

结果

在平均年龄和合并症指数方面具有可比性的情况下,接受氨甲环酸治疗的患者(与未接受治疗的患者相比)异体或自体输血率较低(7.7%对20.1%)、血栓栓塞并发症发生率较低(0.6%对0.8%)、急性肾衰竭发生率较低(1.2%对1.6%)以及综合并发症发生率较低(1.9%对2.6%);所有P<0.01。在多级模型中,氨甲环酸剂量类别(与未使用氨甲环酸相比)与异体或自体输血的几率显著降低(P<0.001)(各剂量类别比值比为0.31至0.38)且并发症风险无显著增加相关:血栓栓塞并发症(比值比0.85至1.02)、急性肾衰竭(0.70至1.11)以及综合并发症(0.75至0.98)。

结论

氨甲环酸在减少输血需求方面有效,同时不增加包括血栓栓塞事件和肾衰竭在内的并发症风险。因此,我们的数据为氨甲环酸在需要骨科手术的患者中的潜在有效性和安全性提供了更多证据。

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