Appelen Diebrecht, van Loo Eva, Prins Martin H, Neumann Martino Ham, Kolbach Dinanda N
Department of Dermatology, Huidcentrum Limburg, Reinaartsingel 50, Maastricht, Netherlands.
Cochrane Database Syst Rev. 2017 Sep 26;9(9):CD004174. doi: 10.1002/14651858.CD004174.pub3.
Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) that is characterised by chronic pain, swelling, and skin changes in the affected limb. One of every three people with DVT will develop post-thrombotic complications within five years. Several non-pharmaceutical measures are used for prevention of post-thrombotic syndrome during the acute phase of DVT. These include elevation of the legs and compression therapy. Clinicians and guidelines differ in their assessment of the utility of compression therapy for treatment of DVT. This is an update of a review first published in 2003.
To determine relative effectiveness and rate of complications when compression therapy is used in people with deep vein thrombosis (DVT) for prevention of post-thrombotic syndrome (PTS).
For this update, the Cochrane Vascular Information Specialist (CIS) searched the Cochrane Vascular Specialised Register (20 March 2017) and CENTRAL (2017, Issue 2). The CIS also searched trial registries for details of ongoing or unpublished studies.
We included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of compression therapy, such as bandaging and elastic stockings, in people with clinically confirmed DVT. The primary outcome was the occurrence of PTS.
Two review authors (DK and EvL) identified and assessed titles and abstracts for relevance, and a third review author (DA) verified this assessment independently. Review authors imposed no restrictions on date or language of publications. Three review authors (DA, DK, EvL) used data extraction sheets to independently extract study data. We resolved disagreements by discussion.
We identified 10 RCTs with a total of 2361 participants that evaluated compression therapy. The overall methodological quality of these trials was low. We used only five studies in meta-analysis owing to differences in intervention types and lack of data. Three studies compared elastic compression stockings (pressure of 30 to 40 mmHg at the ankle) versus no intervention. Two studies compared elastic compression stockings (pressure 20 to 40 mmHg) versus placebo stockings. Overall, use of elastic compression stockings led to a clinically significant reduction in the incidence of PTS (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.38 to 1.01; P = 0.05; 1393 participants; 5 studies; low-quality evidence); no reduction in the incidence of severe PTS (RR 0.78, 95% CI 0.53 to 1.15; P = 0.21; 1224 participants; 4 studies; low-quality evidence); and no clear difference in DVT recurrence (RR 0.94, 95% CI 0.69 to 1.28; 1212 participants; 4 studies; P = 0.69; low-quality evidence). We did not pool data on the incidence of pulmonary embolism because this information was poorly reported, but we observed no differences between groups included in individual studies (low-quality evidence).Two studies evaluated effects of compression in the acute phase versus no compression treatment and found no differences in the incidence of PTS (RR 0.76, 95% CI 0.49 to 1.16; P = 0.2; 101 participants). One study reported that thigh-length stockings did not provide better protection against development of PTS than knee-length stockings (RR 0.92, 95% CI 0.66 to 1.28; P = 0.6; 267 participants). Another trial reported that wearing compression stockings for two years seemed to be superior to wearing them for one year in terms of PTS incidence.Two of the 10 included studies described patient satisfaction and quality of life (moderate-quality evidence), using different measurement systems. The first study showed significant improvement in well-being and DVT-related quality of life with compression treatment (P < 0.05) compared with bed rest, and the second study showed no differences in quality of life scores between compression and placebo groups. Four studies poorly reported side effects (low-quality evidence) that included itching, erythema, and other forms of allergic reaction and described no serious adverse events. Compliance with wearing of compression stockings was generally high but varied across studies.
AUTHORS' CONCLUSIONS: Low-quality evidence suggests that elastic compression stockings may reduce the occurrence of PTS after DVT. We downgraded the quality of evidence owing to considerable heterogeneity between studies and lack of or unclear risk of blinding due to clinical assessment scores. No serious adverse effects occurred in these studies. Large randomised controlled trials are needed to confirm these findings because of current lack of high-quality evidence and considerable heterogeneity.
血栓形成后综合征(PTS)是深静脉血栓形成(DVT)的一种长期并发症,其特征为患肢出现慢性疼痛、肿胀和皮肤改变。每三名DVT患者中就有一人会在五年内出现血栓形成后并发症。在DVT急性期,有几种非药物措施可用于预防血栓形成后综合征。这些措施包括抬高腿部和压迫治疗。临床医生和指南对压迫治疗在DVT治疗中的效用评估存在差异。这是对2003年首次发表的一篇综述的更新。
确定在深静脉血栓形成(DVT)患者中使用压迫治疗预防血栓形成后综合征(PTS)时的相对有效性和并发症发生率。
对于本次更新,Cochrane血管信息专家(CIS)检索了Cochrane血管专业注册库(2017年3月20日)和CENTRAL(2017年第2期)。CIS还检索了试验注册库以获取正在进行或未发表研究的详细信息。
我们纳入了针对临床确诊为DVT的患者进行压迫治疗(如绷带包扎和弹力袜)的随机对照试验(RCT)和对照临床试验(CCT)。主要结局是PTS的发生。
两位综述作者(DK和EvL)识别并评估标题和摘要的相关性,第三位综述作者(DA)独立核实该评估。综述作者对出版物的日期或语言未设限制。三位综述作者(DA、DK、EvL)使用数据提取表独立提取研究数据。我们通过讨论解决分歧。
我们识别出10项RCT,共2361名参与者,这些研究评估了压迫治疗。这些试验的总体方法学质量较低。由于干预类型的差异和数据缺失,我们在荟萃分析中仅使用了5项研究。三项研究比较了弹力压迫袜(脚踝处压力为30至40 mmHg)与不干预。两项研究比较了弹力压迫袜(压力为20至40 mmHg)与安慰剂袜。总体而言,使用弹力压迫袜导致PTS发生率在临床上显著降低(风险比(RR)0.62,95%置信区间(CI)0.38至1.01;P = 0.05;1393名参与者;5项研究;低质量证据);严重PTS发生率未降低(RR 0.78,95% CI 0.53至1.15;P = 0.21;1224名参与者;4项研究;低质量证据);DVT复发无明显差异(RR 0.94,95% CI 0.69至1.28;1212名参与者;4项研究;P = 0.69;低质量证据)。我们未汇总肺栓塞发生率的数据,因为该信息报告不佳,但我们在个别研究纳入的组间未观察到差异(低质量证据)。两项研究评估了急性期压迫与无压迫治疗的效果,发现PTS发生率无差异(RR 0.76,95% CI 0.49至1.16;P = 0.2;101名参与者)。一项研究报告称,大腿长度的袜子在预防PTS方面并不比膝盖长度的袜子提供更好的保护(RR 0.92,95% CI 0.66至1.28;P = 0.6;267名参与者)。另一项试验报告称,就PTS发生率而言,穿两年压迫袜似乎优于穿一年。10项纳入研究中的两项使用不同的测量系统描述了患者满意度和生活质量(中等质量证据)。第一项研究表明,与卧床休息相比,压迫治疗使幸福感和与DVT相关的生活质量有显著改善(P < 0.05),第二项研究表明压迫组和安慰剂组的生活质量得分无差异。四项研究对副作用(低质量证据)报告不佳,副作用包括瘙痒、红斑和其他形式的过敏反应,且未描述严重不良事件。穿压迫袜的依从性总体较高,但各研究有所不同。
低质量证据表明,弹力压迫袜可能会降低DVT后PTS的发生。由于研究之间存在相当大的异质性以及因临床评估评分导致的盲法风险缺乏或不明确,我们降低了证据质量。这些研究中未发生严重不良反应。由于目前缺乏高质量证据且存在相当大的异质性,需要进行大型随机对照试验来证实这些发现。