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胫骨及远端骨骨折手术治疗中静脉血栓栓塞症的化学预防:一项系统评价与荟萃分析

Chemoprophylaxis for Venous Thromboembolism in Operative Treatment of Fractures of the Tibia and Distal Bones: A Systematic Review and Meta-analysis.

作者信息

Patterson Joseph T, Morshed Saam

机构信息

Orthopaedic Trauma Institute, Zuckerberg San Francisco General Hospital and the Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA.

出版信息

J Orthop Trauma. 2017 Sep;31(9):453-460. doi: 10.1097/BOT.0000000000000873.

Abstract

OBJECTIVES

Clinical practice has shifted from therapeutic anticoagulation of any lower extremity venous thromboembolism (VTE) to only thromboses with risk of proximal extension or embolization-clinically important VTE (CIVTE). Isolated operative fractures of the tibia or distal bone of the lower extremity are associated with low-to-intermediate VTE risk, and there is wide variability in the choice to anticoagulate as well as anticoagulant. We sought to evaluate the role for chemoprophylaxis of VTE and CIVTE in these injuries by meta-analysis of Level I evidence.

DATA SOURCES

Articles in English, Chinese, French, and German in MEDLINE, Biosis, and EMBASE from 1988 to 2016.

STUDY SELECTION

Randomized controlled trials describing chemoprophylaxis of VTE after operative management of fractures of the tibia and distal bones. Independent review of 1502 citations yielded 5 studies (1181 patients) meeting inclusion criteria.

DATA EXTRACTION

Chemoprophylaxis regimen, VTE, CIVTE, and major bleeding events were recorded. Study quality was assessed with regard to randomization, outcome assessment allocation and treatment concealment, and commercial funding.

DATA SYNTHESIS

A random-effects model meta-analysis determined that chemoprophylaxis with a low-molecular-weight heparin (LMWH) compared with placebo or no intervention significantly reduced the risk of any VTE [pooled relative risk (RR) = 0.696, 95% confidence interval (0.490-0.989), P = 0.043; homogeneity P = 0.818, I = 0%]. However, chemoprophylaxis with a LMWH compared with placebo did not significantly reduce the risk of CIVTE [RR = 0.865, 95% confidence interval (pooled RR = 0.112-3.863), P = 0.790; homogeneity P = 0.718, I = 0%]. No major bleeding events occurred. Funnel plots did not suggest publication bias. The number needed to treat was 31 patients treated with chemoprophylaxis using a LMWH to prevent 1 VTE and 584 patients to prevent 1 CIVTE.

CONCLUSIONS

Meta-analysis of Level I evidence suggests that routine postoperative anticoagulation after surgical management of an isolated fracture of the tibia or distal bone in patients without risk factors for VTE is unlikely to provide a clinical benefit, based on the absence of a treatment effect for preventing VTE warranting therapeutic anticoagulation.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

摘要

目的

临床实践已从对任何下肢静脉血栓栓塞症(VTE)进行治疗性抗凝,转变为仅对有近端扩展或栓塞风险的血栓形成(即临床重要的VTE,CIVTE)进行抗凝。孤立的胫骨或下肢远端骨手术骨折与低至中度VTE风险相关,在抗凝选择以及抗凝剂使用方面存在很大差异。我们试图通过对一级证据的荟萃分析来评估在这些损伤中VTE和CIVTE化学预防的作用。

数据来源

1988年至2016年MEDLINE、Biosis和EMBASE数据库中收录的英文、中文、法文和德文文章。

研究选择

描述胫骨和远端骨骨折手术治疗后VTE化学预防的随机对照试验。对1502篇文献进行独立审查后,有5项研究(1181例患者)符合纳入标准。

数据提取

记录化学预防方案、VTE、CIVTE和大出血事件。从随机化、结局评估分配和治疗隐匿性以及商业资助方面评估研究质量。

数据合成

随机效应模型荟萃分析确定,与安慰剂或不进行干预相比,使用低分子量肝素(LMWH)进行化学预防可显著降低任何VTE的风险[合并相对风险(RR)=0.696,95%置信区间(0.490 - 0.989),P = 0.043;同质性P = 0.818,I² = 0%]。然而,与安慰剂相比,使用LMWH进行化学预防并未显著降低CIVTE的风险[RR = 0.865,95%置信区间(合并RR = 0.112 - 3.863),P = 0.790;同质性P = 0.718,I² = 0%]。未发生大出血事件。漏斗图未提示发表偏倚。使用LMWH进行化学预防预防1例VTE需要治疗31例患者,预防1例CIVTE需要治疗584例患者。

结论

对一级证据的荟萃分析表明,对于无VTE危险因素的患者,胫骨或远端骨孤立骨折手术治疗后常规术后抗凝不太可能带来临床益处,因为在预防VTE方面缺乏值得进行治疗性抗凝的治疗效果。

证据级别

治疗性一级。有关证据级别的完整描述,请参阅作者指南。

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