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依诺肝素与亭扎肝素用于急性脊髓损伤后康复期静脉血栓栓塞预防的比较:一项回顾性队列研究比较安全性和疗效。

Enoxaparin versus tinzaparin for venous thromboembolic prophylaxis during rehabilitation after acute spinal cord injury: a retrospective cohort study comparing safety and efficacy.

机构信息

Feinberg Medical School and The Rehabilitation Institute of Chicago, Northwestern University, Room 1154, 345 E. Superior, Chicago, IL 60611, USA.

出版信息

PM R. 2012 Jan;4(1):11-7. doi: 10.1016/j.pmrj.2011.10.007.

DOI:10.1016/j.pmrj.2011.10.007
PMID:22269449
Abstract

OBJECTIVE

To compare the safety and efficacy of 3 low-molecular-weight heparin (LMWH) treatments (enoxaparin, 40 mg once daily, with an alternative LMWH, tinzaparin, 3500 or 4500 units once daily) for the prevention of venous thromboembolic events (VTEs) after acute spinal cord injury (SCI).

DESIGN

Retrospective, chart review study.

SETTING

Acute inpatient rehabilitation facility.

PARTICIPANTS

Patients admitted to acute rehabilitation within 3 months of either a traumatic or nontraumatic SCI during a 15-month time frame and who received either enoxaparin or tinzaparin for VTE prophylaxis.

MAIN OUTCOME MEASURES

Symptomatic VTE incidence and bleeding events during acute rehabilitation.

RESULTS

A total of 140 participants who met inclusion criteria were admitted at a median of 15 days after an acute SCI. Before admission to rehabilitation, 23.6% were not on any VTE prophylaxis, 55.7% were on enoxaparin, 17.1% were on unfractionated heparin, 1.4% were on treatment doses of a LMWH, and 2.1% did not have documentation available regarding type of prophylaxis before admission. No patients were receiving tinzaparin before admission. During rehabilitation, 68 participants received prophylaxis with enoxaparin, whereas 14 and 58 participants received tinzaparin 3500 or 4500 units, respectively. Symptomatic VTE developed in 14 patients during rehabilitation, including 4 developing pulmonary emboli. Compared with patients receiving tinzaparin 3500 units, both those receiving enoxaparin had significantly reduced odds of VTE (odds ratio [OR] 0.12; 95% confidence interval [95% CI] 0.02-0.65)] and those receiving tinzaparin 4500 units had significantly reduced odds of VTE (OR 0.18; 95% CI 0.03-0.93). After we adjusted for age, previous pharmacologic prophylaxis, and etiology for the SCI (traumatic vs nontraumatic) via propensity scores, pharmacologic prophylaxis with enoxaparin remained protective for VTE compared with tinzaparin 3500 units (adjusted OR 0.15; 95% CI 0.02-0.93). The use of prophylaxis before admission with enoxaparin compared with no prophylaxis was associated with decreased risk of VTE during rehabilitation (adjusted OR 0.20; 95% CI 0.04-0.88); however, this association was no longer significant when we adjusted for prophylaxis during rehabilitation. The etiology for the SCI and the presence of an inferior vena cava filter were not associated with VTE. One patient receiving enoxaparin required transfer for a bleeding event, and no patients had greater than a 1-g decrease in hemoglobin during the rehabilitation stay.

CONCLUSIONS

VTE was more prevalent in participants receiving tinzaparin 3500 units than in participants who received tinzaparin 4500 units or enoxaparin. Bleeding events were low with the use of LMWH for prophylaxis during acute rehabilitation. Although the use of prophylaxis before rehabilitation may be protective of VTE events, after we adjusted for VTE prophylaxis during rehabilitation, type of previous prophylaxis was not found to be significantly protective of VTE events during rehabilitation.

摘要

目的

比较 3 种低分子肝素(LMWH)治疗方案(依诺肝素,40mg,每日 1 次;另一种 LMWH,那屈肝素钙,3500 或 4500 单位,每日 1 次)预防急性脊髓损伤(SCI)后静脉血栓栓塞事件(VTE)的安全性和疗效。

设计

回顾性、图表回顾研究。

地点

急性住院康复机构。

参与者

在 15 个月的时间内,因创伤性或非创伤性 SCI 入住急性康复病房 3 个月内的患者,接受依诺肝素或那屈肝素钙预防 VTE。

主要观察指标

急性康复期间症状性 VTE 发生率和出血事件。

结果

共纳入 140 名符合纳入标准的参与者,在急性 SCI 后中位数 15 天入院。入院前,23.6%的患者未接受任何 VTE 预防治疗,55.7%的患者接受依诺肝素治疗,17.1%的患者接受未分级肝素治疗,1.4%的患者接受 LMWH 治疗剂量,2.1%的患者入院前无预防治疗类型的记录。入院前没有患者接受那屈肝素钙治疗。在康复期间,68 名患者接受依诺肝素预防治疗,14 名和 58 名患者分别接受那屈肝素钙 3500 或 4500 单位预防治疗。14 名患者在康复期间发生症状性 VTE,包括 4 例肺栓塞。与接受那屈肝素钙 3500 单位的患者相比,接受依诺肝素治疗的患者 VTE 的可能性显著降低(比值比[OR]0.12;95%置信区间[95%CI]0.02-0.65),接受那屈肝素钙 4500 单位的患者 VTE 的可能性显著降低(OR 0.18;95%CI 0.03-0.93)。通过倾向评分调整年龄、既往药物预防和 SCI 病因(创伤性与非创伤性)后,依诺肝素药物预防与那屈肝素钙 3500 单位相比仍然具有 VTE 保护作用(调整 OR 0.15;95%CI 0.02-0.93)。与未预防治疗相比,入院前使用依诺肝素预防治疗与康复期间 VTE 风险降低相关(调整 OR 0.20;95%CI 0.04-0.88);然而,当我们调整康复期间的预防治疗时,这种关联不再显著。SCI 的病因和下腔静脉滤器的存在与 VTE 无关。1 名接受依诺肝素治疗的患者因出血事件需要转院,在康复期间没有患者血红蛋白下降超过 1g。

结论

与接受那屈肝素钙 4500 单位的患者相比,接受那屈肝素钙 3500 单位的患者 VTE 更为常见。在急性康复期间使用 LMWH 进行预防治疗时,出血事件较少。尽管在康复前使用预防治疗可能对 VTE 事件有保护作用,但在调整康复期间的 VTE 预防治疗后,未发现之前的预防治疗类型对康复期间的 VTE 事件有显著保护作用。

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