O'Meara Susan, Cullum Nicky A, Nelson E Andrea
Department of Health Sciences, University of York, Area 3 Seebohm Rowntree Building, Heslington, York, UK, YO10 5DD.
Cochrane Database Syst Rev. 2009 Jan 21(1):CD000265. doi: 10.1002/14651858.CD000265.pub2.
Around one percent of people in industrialised countries will suffer from a leg ulcer at some time. The majority of these leg ulcers are due to problems in the veins, resulting in an accumulation of blood in the legs. Leg ulcers arising from venous problems are called venous (varicose or stasis) ulcers. The main treatment has been a firm compression garment (bandage or stocking) in order to aid venous return. There is a large number of compression garments available and it is unclear whether they are effective in treating venous ulcers and which compression garment is the most effective.
To undertake a systematic review of all randomised controlled trials of the clinical effectiveness of compression bandage or stocking systems in the treatment of venous leg ulceration.Specific questions addressed by the review are:1. Does the application of compression bandages or stockings aid venous ulcer healing? 2. Which compression bandage or stocking system is the most effective?
For this update we searched the Cochrane Wounds Group Specialised Register (14/10/08); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4 2008); Ovid MEDLINE (1950 to October Week 1 2008); Ovid EMBASE (1980 to 2008 Week 41) and Ovid CINAHL (1982 to October Week 1 2008). No date or language restrictions were applied.
Randomised controlled trials recruiting people with venous leg ulceration that evaluated any type of compression bandage system or compression hosiery were eligible for inclusion. Comparators included no compression (e.g. primary dressing alone, non-compressive bandage) or an alternative type of compression. Trials had to report an objective measure of ulcer healing in order to be included (primary outcome for the review). Secondary outcomes of the review included ulcer recurrence, costs, quality of life, pain, adverse events and withdrawals. There was no restriction on date, language or publication status of trials.
Details of eligible studies were extracted and summarised using a data extraction table. Data extraction was performed by one review author and verified independently by a second review author.
Overall, 39 RCTs reporting 47 comparisons were included.Review question 1: there was reasonable evidence from seven RCTs that venous ulcers heal more rapidly with compression than without.Review question 2: findings from six trials of single-component compression suggested that this strategy was less effective than multi-component compression. Evidence from compression systems with two components (3 trials) and three components (4 trials) suggested better outcomes when an elastic component was included. Different versions of compression with four-components (based on the Charing Cross four-layer bandage system) have similar effectiveness (3 trials). Compression with four components (variants of the Charing Cross four-layer bandage) is more effective than multi-component compression that includes a short-stretch bandage (6 trials). It is difficult to determine the relative effectiveness of the four-layer bandage compared with paste bandage systems because of differences in the paste systems (5 trials). There was no difference in effectiveness between the adjustable compression boot and compression bandages (2 trials) or between single-layer compression stockings and paste bandages (2 trials). Two-layer stockings appeared more effective than the short-stretch bandage (2 trials). The relative effectiveness of tubular compression when compared with compression bandages was not clear from current evidence (2 trials).Three trials reported ulcer recurrence; because of sparseness of data and trials not being primarily designed to assess this outcome, firm conclusions could not be drawn. Although several trials included cost data, only one reported a rigorously conducted cost-effectiveness analysis with findings suggesting that the four-layer bandage was more cost-effective than multi-component compression comprising a short-stretch bandage. Seven trials assessed health-related quality of life and none observed significant differences between treatment groups. Several trials evaluated pain either as a stand-alone outcome, or as part of the assessment of adverse events. In general, the data did not indicate clear differences between treatment groups. It is possible that stockings could be associated with less pain than bandages but in view of scarcity of available data this requires further evaluation. Many of the trials reported adverse events and / or withdrawals. Overall, these outcomes appeared similar across different treatment groups.
AUTHORS' CONCLUSIONS: Compression increases ulcer healing rates compared with no compression. Multi-component systems are more effective than single-component systems. Multi-component systems containing an elastic bandage appear more effective than those composed mainly of inelastic constituents.
在工业化国家,约1%的人在一生中的某个时候会患腿部溃疡。这些腿部溃疡大多是由静脉问题引起的,导致腿部血液积聚。因静脉问题引发的腿部溃疡被称为静脉(曲张或淤积)性溃疡。主要治疗方法是使用紧绷的加压衣物(绷带或长袜)以促进静脉回流。市面上有大量的加压衣物,目前尚不清楚它们在治疗静脉溃疡方面是否有效,以及哪种加压衣物效果最佳。
对所有关于加压绷带或长袜系统治疗下肢静脉溃疡临床疗效的随机对照试验进行系统评价。本评价要解决的具体问题是:1. 使用加压绷带或长袜是否有助于静脉溃疡愈合?2. 哪种加压绷带或长袜系统最有效?
本次更新检索了Cochrane伤口小组专业注册库(2008年10月14日);Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2008年第4期);Ovid MEDLINE(1950年至2008年10月第1周);Ovid EMBASE(1980年至2008年第41周)以及Ovid CINAHL(1982年至2008年10月第1周)。检索无日期或语言限制。
招募下肢静脉溃疡患者并评估任何类型加压绷带系统或加压长袜的随机对照试验均符合纳入标准。对照包括不加压(如仅使用初级敷料、非加压绷带)或其他类型的加压方式。试验必须报告溃疡愈合的客观测量指标才能纳入(本评价的主要结局)。本评价的次要结局包括溃疡复发、成本、生活质量、疼痛、不良事件和退出试验情况。试验的日期、语言或发表状态均无限制。
使用数据提取表提取并总结符合条件研究的详细信息。数据提取由一位评价作者完成,另一位评价作者独立进行核实。
总体而言,纳入了39项报告47组比较的随机对照试验。评价问题1:7项随机对照试验提供了合理证据,表明加压治疗的静脉溃疡比不加压愈合更快。评价问题2:6项单组分加压试验的结果表明,该策略不如多组分加压有效。两项组分(3项试验)和三项组分(4项试验)加压系统的证据表明,包含弹性组分时效果更好。不同版本的四组分加压(基于查令十字四层绷带系统)效果相似(3项试验)。四组分加压(查令十字四层绷带变体)比包含短拉伸绷带的多组分加压更有效(6项试验)。由于糊剂系统存在差异,难以确定四层绷带与糊剂绷带系统相比的相对有效性(5项试验)。可调式加压靴与加压绷带之间(2项试验)或单层加压长袜与糊剂绷带之间(2项试验)效果无差异。双层长袜似乎比短拉伸绷带更有效(2项试验)。从现有证据来看,管状加压与加压绷带相比的相对有效性尚不清楚(2项试验)。三项试验报告了溃疡复发情况;由于数据稀少且试验并非主要设计用于评估该结局,无法得出确切结论。尽管有几项试验纳入了成本数据,但只有一项进行了严格的成本效益分析,结果表明四层绷带比包含短拉伸绷带的多组分加压更具成本效益。7项试验评估了与健康相关的生活质量,未观察到治疗组之间存在显著差异。几项试验将疼痛作为独立结局或作为不良事件评估的一部分进行了评估。总体而言,数据未表明治疗组之间存在明显差异。长袜引起的疼痛可能比绷带少,但鉴于现有数据不足,这需要进一步评估。许多试验报告了不良事件和/或退出试验情况。总体而言,这些结局在不同治疗组中似乎相似。
与不加压相比,加压可提高溃疡愈合率。多组分系统比单组分系统更有效。包含弹性绷带的多组分系统似乎比主要由非弹性成分组成的系统更有效。