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一项大型临床系列回顾:高危创伤患者中依诺肝素预防静脉血栓栓塞症的每日一次与每日两次给药方案比较。

Review of a large clinical series: once- versus twice-daily enoxaparin for venous thromboembolism prophylaxis in high-risk trauma patients.

机构信息

Department of Pharmacy Services, Greenville Hospital System, Greenville, SC, USA.

出版信息

J Intensive Care Med. 2011 Mar-Apr;26(2):111-5. doi: 10.1177/0885066610384462. Epub 2011 Jan 21.

Abstract

BACKGROUND

Consensus guidelines support the use of low-molecular-weight heparin for venous thromboembolism (VTE) prophylaxis in high-risk trauma patients but do not recommend a specific regimen. The current study compared the effectiveness and safety of enoxaparin 40 mg once-daily versus enoxaparin 30 mg twice-daily for VTE prophylaxis in high-risk trauma patients.

METHODS

A retrospective chart review was conducted of all trauma patients older than 18 years of age admitted to Shands at the University of Florida between July 1, 2005 and June 30, 2007, who received either dosing regimen. Excluded were patients with Injury Severity Score <9, surviving <2 days, hospital length of stay <2 days, receipt of >1 agent, and/or dosing regimen for VTE prophylaxis during hospitalization, interruption in therapy, pregnancy, or diagnosis of a VTE within 24 hours of admission.

RESULTS

A total of 409 patients were treated with once-daily dosing and 278 patients were treated with twice-daily dosing. The overall rate of VTE was 2.9% (95% confidence interval, 1.52, 5.07) in the once-daily group and 1.1% in the twice-daily group (95% confidence interval, 0.22, 3.12; P = .118). Major bleeding occurred in 11 patients in the once-daily group and 5 patients in the twice-daily group (1.8% vs 2.7%; P = .608).

CONCLUSION

Enoxaparin 30 mg twice-daily may be more effective than enoxaparin 40 mg once-daily for prevention of VTE in high-risk trauma patients; however, statistical significance was not achieved. There were no statistically significant differences observed in clinically significant bleeding. Further study is needed to clarify which dosing regimen of enoxaparin is superior with regard to safety and effectiveness.

摘要

背景

共识指南支持在高危创伤患者中使用低分子肝素预防静脉血栓栓塞症(VTE),但不推荐具体方案。本研究比较了每日一次给予依诺肝素 40mg 与每日两次给予依诺肝素 30mg 用于高危创伤患者 VTE 预防的有效性和安全性。

方法

对 2005 年 7 月 1 日至 2007 年 6 月 30 日期间在佛罗里达大学 Shands 医院就诊的年龄大于 18 岁、接受任一剂量方案的所有创伤患者进行回顾性图表审查。排除标准为损伤严重度评分<9 分、存活<2 天、住院时间<2 天、接受>1 种药物、以及/或住院期间接受 VTE 预防治疗方案中断、妊娠或入院后 24 小时内诊断 VTE。

结果

共 409 例患者接受每日一次给药,278 例患者接受每日两次给药。每日一次组 VTE 发生率为 2.9%(95%置信区间,1.52,5.07),每日两次组为 1.1%(95%置信区间,0.22,3.12;P=.118)。每日一次组 11 例患者发生大出血,每日两次组 5 例(1.8%比 2.7%;P=.608)。

结论

依诺肝素 30mg 每日两次给药可能比依诺肝素 40mg 每日一次给药更有效预防高危创伤患者的 VTE;但未达到统计学显著性。在有临床意义的出血方面,未观察到统计学显著差异。需要进一步研究以明确依诺肝素的哪种剂量方案在安全性和有效性方面更具优势。

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