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迈向基于证据的静脉血栓栓塞预防指南:对机械方法、口服抗凝药、右旋糖酐及区域麻醉作为血栓预防措施的系统评价

Towards evidence-based guidelines for the prevention of venous thromboembolism: systematic reviews of mechanical methods, oral anticoagulation, dextran and regional anaesthesia as thromboprophylaxis.

作者信息

Roderick P, Ferris G, Wilson K, Halls H, Jackson D, Collins R, Baigent C

机构信息

Health Care Research Unit, University of Southampton, UK.

出版信息

Health Technol Assess. 2005 Dec;9(49):iii-iv, ix-x, 1-78. doi: 10.3310/hta9490.

Abstract

OBJECTIVES

To assess the benefits in terms of reductions in the risks of deep vein thrombosis (DVT) and of pulmonary embolism (PE), and hazards in terms of major bleeding, of: (i) mechanical compression; (ii) oral anticoagulants; (iii) dextran; and (iv) regional anaesthesia (as an alternative to general anaesthesia) in surgical and medical patients.

DATA SOURCES

Electronic databases, search of Antithrombotic Trialists' Collaboration database, contact with trialists and manufacturers.

REVIEW METHODS

All trials identified as fitting the selection criteria were independently assessed. The primary outcomes were DVT, PE and major bleeding events, and proximal venous thrombosis (PVT) and fatal PE were secondary outcomes. Trials were subdivided into those that had assessed a method as the only means of thromboprophylaxis ('monotherapy') and those that had assessed the effects of adding a method to another form of thromboprophylaxis ('adjunctive therapy').

RESULTS

Mechanical compression methods reduced the risk of DVT by about two-thirds when used as monotherapy and by about half when added to a pharmacological method. These benefits were similar irrespective of the particular method used (graduated compression stockings, intermittent pneumatic compression or footpumps) and were similar in each of the surgical groups studied. Mechanical methods reduced the risk of PVT by about half and the risk of PE by two-fifths. Oral anticoagulants, when used as monotherapy, reduced the risk of DVT and of PVT by about half, and this protective effect appeared similar in each of the surgical groups studied. There was an apparently large four-fifths reduction in the role of PE, but not only was the magnitude of this reduction statistically uncertain, but also pulmonary embolism was reported by a minority of trials, so it may be subject to selection bias. Oral anticoagulant regimens approximately doubled the risk of major bleeding and appeared less effective at preventing DVT than heparin regimens, although were associated with less major bleeding. Dextran reduced the risk of DVT and of PVT by about half, again irrespective of the type of surgery, but too few studies had reported PE to provide reliable estimates of effect on this outcome. Dextran appeared to be less effective at preventing DVT than the heparin regimens studied. Dextran was associated with an increased risk of bleeding, but too few bleeds had occurred for the size of this excess risk to be estimated reliably. Compared with general anaesthesia, regional anaesthesia reduced the risk of DVT by about half, and this benefit appeared similar in each of the surgical settings studied. Regional anaesthesia was associated with less major bleeding than general anaesthesia.

CONCLUSIONS

In the absence of a clear contraindication (such as severe peripheral arterial disease), patients undergoing a surgical procedure would be expected to derive net benefit from a mechanical compression method of thromboprophylaxis (such as graduated compression stockings), irrespective of their absolute risk of venous thromboembolism. Patients who are considered to be at particularly high risk of venous thromboembolism may also benefit from a pharmacological thromboprophylactic agent, but since oral anticoagulant and dextran regimens appear less effective at preventing DVT than standard low-dose unfractionated heparin or low molecular weight heparin regimens, they may be less suitable for patients at high risk of venous thromboembolism, even though they are associated with less bleeding. Whenever feasible, the use of regional anaesthesia as an alternative to general anaesthesia may also provide additional protection against venous thromboembolism. There is little information on the prevention of venous thromboembolism among high-risk medical patients (such as those with stroke), so further randomised trials in this area would be helpful.

摘要

目的

评估以下措施在降低深静脉血栓形成(DVT)和肺栓塞(PE)风险方面的益处以及在大出血方面的危害:(i)机械压迫;(ii)口服抗凝剂;(iii)右旋糖酐;(iv)区域麻醉(作为全身麻醉的替代方法)在外科和内科患者中的应用。

数据来源

电子数据库、检索抗栓治疗协作组数据库、与试验研究者及制造商联系。

综述方法

对所有符合入选标准的试验进行独立评估。主要结局为DVT、PE和大出血事件,近端静脉血栓形成(PVT)和致死性PE为次要结局。试验分为评估一种方法作为唯一血栓预防手段的试验(“单一疗法”)和评估将一种方法添加到另一种血栓预防形式中的效果的试验(“辅助疗法”)。

结果

机械压迫方法作为单一疗法使用时可使DVT风险降低约三分之二,添加到药物方法中时可降低约一半。无论使用何种具体方法(分级压力袜、间歇性气动压迫或足部泵),这些益处相似,且在所研究的每个外科手术组中也相似。机械方法可使PVT风险降低约一半,使PE风险降低五分之二。口服抗凝剂作为单一疗法使用时,可使DVT和PVT风险降低约一半,在所研究的每个外科手术组中这种保护作用似乎相似。PE的发生率明显降低了五分之四,但不仅这种降低幅度在统计学上不确定,而且少数试验报告了肺栓塞情况,因此可能存在选择偏倚。口服抗凝方案使大出血风险增加约一倍,且在预防DVT方面似乎不如肝素方案有效,尽管其大出血发生率较低。右旋糖酐可使DVT和PVT风险降低约一半,同样与手术类型无关,但报告PE的研究过少,无法提供对该结局影响的可靠估计。右旋糖酐在预防DVT方面似乎不如所研究的肝素方案有效。右旋糖酐与出血风险增加相关,但发生的出血过少,无法可靠估计这种额外风险的大小。与全身麻醉相比,区域麻醉可使DVT风险降低约一半,且在所研究的每个手术环境中这种益处相似。区域麻醉与比全身麻醉更少的大出血相关。

结论

在没有明确禁忌证(如严重外周动脉疾病)的情况下,接受外科手术的患者无论其静脉血栓栓塞的绝对风险如何,预计均可从机械压迫血栓预防方法(如分级压力袜)中获得净益处。被认为静脉血栓栓塞风险特别高的患者也可能从药物血栓预防剂中获益,但由于口服抗凝剂和右旋糖酐方案在预防DVT方面似乎不如标准低剂量普通肝素或低分子量肝素方案有效,因此它们可能不太适合静脉血栓栓塞高风险患者,尽管它们与较少的出血相关。只要可行,使用区域麻醉替代全身麻醉也可能为预防静脉血栓栓塞提供额外保护。关于高危内科患者(如中风患者)静脉血栓栓塞预防的信息很少,因此该领域进一步的随机试验将很有帮助。

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