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用于预防深静脉血栓形成的梯度压力弹力袜。

Graduated compression stockings for prevention of deep vein thrombosis.

作者信息

Sachdeva Ashwin, Dalton Mark, Lees Timothy

机构信息

Wellcome Centre for Mitochondrial Research, Newcastle University, 4th floor, Cookson Building, Medical School, Framlington Place, Newcastle upon Tyne, UK, NE2 4HH.

出版信息

Cochrane Database Syst Rev. 2018 Nov 3;11(11):CD001484. doi: 10.1002/14651858.CD001484.pub4.

Abstract

BACKGROUND

Hospitalised patients are at increased risk of developing deep vein thrombosis (DVT) in the lower limb and pelvic veins, on a background of prolonged immobilisation associated with their medical or surgical illness. Patients with DVT are at increased risk of developing a pulmonary embolism (PE). The use of graduated compression stockings (GCS) in hospitalised patients has been proposed to decrease the risk of DVT. This is an update of a Cochrane Review first published in 2000, and last updated in 2014.

OBJECTIVES

To evaluate the effectiveness and safety of graduated compression stockings in preventing deep vein thrombosis in various groups of hospitalised patients.

SEARCH METHODS

For this review the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), and trials registries on 21 March 2017; and the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE Ovid, Embase Ovid, CINAHL Ebsco, AMED Ovid , and trials registries on 12 June 2018.

SELECTION CRITERIA

Randomised controlled trials (RCTs) involving GCS alone, or GCS used on a background of any other DVT prophylactic method. We combined results from both of these groups of trials.

DATA COLLECTION AND ANALYSIS

Two review authors (AS, MD) assessed potentially eligible trials for inclusion. One review author (AS) extracted the data, which a second review author (MD) cross-checked and authenticated. Two review authors (AS, MD) assessed the methodological quality of trials with the Cochrane 'Risk of bias' tool. Any disagreements were resolved by discussion with the senior review author (TL). For dichotomous outcomes, we calculated the Peto odds ratio and corresponding 95% confidence interval. We pooled data using a fixed-effect model. We used the GRADE system to evaluate the overall quality of the evidence supporting the outcomes assessed in this review.

MAIN RESULTS

We included 20 RCTs involving a total of 1681 individual participants and 1172 individual legs (2853 analytic units). Of these 20 trials, 10 included patients undergoing general surgery; six included patients undergoing orthopaedic surgery; three individual trials included patients undergoing neurosurgery, cardiac surgery, and gynaecological surgery, respectively; and only one trial included medical patients. Graduated compression stockings were applied on the day before surgery or on the day of surgery and were worn up until discharge or until the participants were fully mobile. In the majority of the included studies DVT was identified by the radioactive I uptake test. Duration of follow-up ranged from seven to 14 days. The included studies were at an overall low risk of bias.We were able to pool the data from 20 studies reporting the incidence of DVT. In the GCS group, 134 of 1445 units developed DVT (9%) in comparison to the control group (without GCS), in which 290 of 1408 units developed DVT (21%). The Peto odds ratio (OR) was 0.35 (95% confidence interval (CI) 0.28 to 0.43; 20 studies; 2853 units; high-quality evidence), showing an overall effect favouring treatment with GCS (P < 0.001).Based on results from eight included studies, the incidence of proximal DVT was 7 of 517 (1%) units in the GCS group and 28 of 518 (5%) units in the control group. The Peto OR was 0.26 (95% CI 0.13 to 0.53; 8 studies; 1035 units; moderate-quality evidence) with an overall effect favouring treatment with GCS (P < 0.001). Combining results from five studies, all based on surgical patients, the incidence of PE was 5 of 283 (2%) participants in the GCS group and 14 of 286 (5%) in the control group. The Peto OR was 0.38 (95% CI 0.15 to 0.96; 5 studies; 569 participants; low-quality evidence) with an overall effect favouring treatment with GCS (P = 0.04). We downgraded the quality of the evidence for proximal DVT and PE due to low event rate (imprecision) and lack of routine screening for PE (inconsistency).We carried out subgroup analysis by speciality (surgical or medical patients). Combining results from 19 trials focusing on surgical patients, 134 of 1365 (9.8%) units developed DVT in the GCS group compared to 282 of 1328 (21.2%) units in the control group. The Peto OR was 0.35 (95% CI 0.28 to 0.44; high-quality evidence), with an overall effect favouring treatment with GCS (P < 0.001). Based on results from seven included studies, the incidence of proximal DVT was 7 of 437 units (1.6%) in the GCS group and 28 of 438 (6.4%) in the control group. The Peto OR was 0.26 (95% CI 0.13 to 0.53; 875 units; moderate-quality evidence) with an overall effect favouring treatment with GCS (P < 0.001). We downgraded the evidence for proximal DVT due to low event rate (imprecision).Based on the results from one trial focusing on medical patients admitted following acute myocardial infarction, 0 of 80 (0%) legs developed DVT in the GCS group and 8 of 80 (10%) legs developed DVT in the control group. The Peto OR was 0.12 (95% CI 0.03 to 0.51; low-quality evidence) with an overall effect favouring treatment with GCS (P = 0.004). None of the medical patients in either group developed a proximal DVT, and the incidence of PE was not reported.Limited data were available to accurately assess the incidence of adverse effects and complications with the use of GCS as these were not routinely quantitatively reported in the included studies.

AUTHORS' CONCLUSIONS: There is high-quality evidence that GCS are effective in reducing the risk of DVT in hospitalised patients who have undergone general and orthopaedic surgery, with or without other methods of background thromboprophylaxis, where clinically appropriate. There is moderate-quality evidence that GCS probably reduce the risk of proximal DVT, and low-quality evidence that GCS may reduce the risk of PE. However, there remains a paucity of evidence to assess the effectiveness of GCS in diminishing the risk of DVT in medical patients.

摘要

背景

住院患者因内科或外科疾病导致长期制动,下肢和盆腔静脉发生深静脉血栓形成(DVT)的风险增加。DVT患者发生肺栓塞(PE)的风险也增加。有人提出在住院患者中使用分级加压弹力袜(GCS)来降低DVT风险。这是Cochrane系统评价的更新版,该评价首次发表于2000年,上次更新于2014年。

目的

评估分级加压弹力袜预防各类住院患者深静脉血栓形成的有效性和安全性。

检索方法

本次评价中,Cochrane血管信息专家于2017年3月21日检索了Cochrane血管专科注册库、Cochrane对照试验中心注册库(CENTRAL)及各试验注册库;并于2018年6月12日检索了Cochrane血管专科注册库、CENTRAL、Ovid MEDLINE、Ovid Embase、Ebsco CINAHL、Ovid AMED及各试验注册库。

入选标准

随机对照试验(RCT),单独使用GCS,或在任何其他DVT预防方法的基础上使用GCS。我们合并了这两组试验的结果。

数据收集与分析

两位综述作者(AS、MD)评估了可能符合纳入标准的试验。一位综述作者(AS)提取数据,另一位综述作者(MD)进行交叉核对和验证。两位综述作者(AS、MD)使用Cochrane“偏倚风险”工具评估试验的方法学质量。任何分歧均通过与资深综述作者(TL)讨论解决。对于二分法结局,我们计算Peto比值比及相应的95%置信区间。我们使用固定效应模型合并数据。我们使用GRADE系统评估支持本评价中所评估结局的证据的总体质量。

主要结果

我们纳入了20项RCT,共1681例个体参与者和1172条腿(2853个分析单元)。在这20项试验中,10项纳入了接受普通外科手术的患者;6项纳入了接受骨科手术的患者;3项单独试验分别纳入了接受神经外科手术、心脏手术和妇科手术的患者;只有1项试验纳入了内科患者。分级加压弹力袜在手术前一天或手术当天应用,直至出院或直至参与者完全活动自如。在大多数纳入研究中,DVT通过放射性碘摄取试验确定。随访时间为7至14天。纳入研究的总体偏倚风险较低。我们能够合并20项报告DVT发生率的研究的数据。在GCS组中,1445个单元中有134个发生DVT(9%),而对照组(未使用GCS)中,1408个单元中有290个发生DVT(21%)。Peto比值比(OR)为0.35(95%置信区间(CI)0.28至0.43;20项研究;2853个单元;高质量证据),表明总体效果支持使用GCS治疗(P<0.001)。基于8项纳入研究的结果,GCS组近端DVT的发生率为517个单元中的7个(1%),对照组为518个单元中的28个(5%)。Peto OR为0.26(95%CI 0.13至0.53;8项研究;1035个单元;中等质量证据),总体效果支持使用GCS治疗(P<0.001)。合并5项均基于外科患者的研究结果,GCS组PE的发生率为283名参与者中的5名(2%),对照组为286名中的14名(5%)。Peto OR为0.38(95%CI 0.15至0.96;5项研究;569名参与者;低质量证据),总体效果支持使用GCS治疗(P=

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