Briggs Michelle, Nelson E Andrea
School of Healthcare, University of Leeds, Baines Wing, Leeds, UK, LS2 9JT.
Cochrane Database Syst Rev. 2010 Apr 14(4):CD001177. doi: 10.1002/14651858.CD001177.pub2.
BACKGROUND: Venous leg ulcers affect up to 1 per cent of people at some time in their lives. The main treatments are compression bandages and dressings. As these ulcers are often painful some clinicians choose particular dressings and topical treatments (analgesia/ local anaesthetic) to reduce the pain both during and between dressing changes. OBJECTIVES: To assess the effectiveness of dressings, local anaesthetics or topical analgesia for pain relief in venous leg ulceration. SEARCH STRATEGY: For this update the search strings were revised and the following databases were searched: The Cochrane Wounds Group Specialised Register (Searched 16/12/09) The Cochrane Central Register of Controlled Trials (CENTRAL) - The Cochrane Library Issue 4 2009; Ovid MEDLINE - 1950 to November Week 3 2009; Ovid EMBASE - 1980 to 2009 Week 50; EBSCO CINAHL - 1982 to December 16 2009. No date or language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials which evaluated local interventions used to relieve venous leg ulcer pain were considered. Pain was defined as either persistent pain or pain at dressing changes or debridement. Ulcer healing and reported adverse events were also considered as further outcomes. DATA COLLECTION AND ANALYSIS: Eligibility for inclusion was confirmed by two review authors who independently assessed the potential trials. MAIN RESULTS: Two trials evaluating interventions for persistent venous leg ulcer pain were identified for this review update. Both studies evaluated ibuprofen slow release foam dressings; one comparing it with local best practice and the other with an identical foam comparator. The primary end point for both studies was "pain relief achieved". When compared with a foam dressing alone, there was no evidence of a statistically significant effect of the ibuprofen foam dressing in terms of achieving some pain relief the first evening after treatment: 74% in the ibuprofen group (46/62) had pain relief compared with 58% (35/60) in the foam group (no significant difference: RR 1.27, 95%CI 0.98 to 1.65). In the second study 100% (32/32) of people with venous ulcers achieved some pain relief with the ibuprofen dressing on the first evening of treatment compared with 93% (26/28) in the local best practice group (no significant difference: RR 1.08, 95% CI 0.96 to 1.21). Pooling these studies in a meta-analysis (using a random effects model as significant heterogeneity present (p=0.1), I(2) = 64%) there is no evidence that ibuprofen dressings increase the pain relief experienced by the first evening of use (RR 1.15, 95% CI 0.91 to 1.44). We were not able to extract sufficient data to combine other pain outcomes from these trials. There was no difference in healing rates but slightly more adverse events with ibuprofen dressings than with a similar foam dressing without ibuprofen.Six trials evaluated interventions for the pain associated with debridement and were considered sufficiently similar to pool. There was a statistically significant reduction in debridement pain scores with 5% Eutectic Mixture of Local Anaesthetics (EMLA): lidocaine-prilocaine cream; the difference in means (measured on a 100 mm scale) was 20.6 mm (95% CI 12.19 to 29.11). Of these six trials, only one small trial measured healing as an outcome and found no difference in the numbers of ulcers healed at the end of the study. AUTHORS' CONCLUSIONS: There is no evidence that ibuprofen dressings offer pain relief, as measured at the first evening of use, to people with painful venous leg ulcers compared with foam dressings or best practice.EMLA appears to provide effective pain relief for venous leg ulcer debridement but the effect (if any) of EMLA on ulcer healing remains unknown.
背景:腿部静脉溃疡在人们一生中的某些时候影响着高达1%的人群。主要治疗方法是加压绷带和敷料。由于这些溃疡常常疼痛,一些临床医生会选择特定的敷料和局部治疗(镇痛/局部麻醉)以在换药期间及换药间隔减轻疼痛。 目的:评估敷料、局部麻醉药或局部镇痛在缓解腿部静脉溃疡疼痛方面的有效性。 检索策略:为进行此次更新,对检索词进行了修订,并检索了以下数据库:Cochrane伤口小组专业注册库(2009年12月16日检索);Cochrane对照试验中心注册库(CENTRAL)——Cochrane图书馆2009年第4期;Ovid MEDLINE——1950年至2009年第11周第3期;Ovid EMBASE——1980年至2009年第50周;EBSCO CINAHL——1982年至2009年12月16日。未设置日期或语言限制。 入选标准:考虑评估用于缓解腿部静脉溃疡疼痛的局部干预措施的随机对照试验。疼痛定义为持续性疼痛或换药或清创时的疼痛。溃疡愈合情况及报告的不良事件也作为进一步的结局进行考量。 数据收集与分析:两名综述作者独立评估潜在试验以确认纳入资格。 主要结果:本次综述更新确定了两项评估针对持续性腿部静脉溃疡疼痛干预措施的试验。两项研究均评估了布洛芬缓释泡沫敷料;一项将其与当地最佳实践进行比较,另一项与相同的泡沫对照物进行比较。两项研究的主要终点均为“实现疼痛缓解”。与单独使用泡沫敷料相比,在治疗后第一个晚上实现某种程度疼痛缓解方面,没有证据表明布洛芬泡沫敷料有统计学上的显著效果:布洛芬组74%(46/62)的患者疼痛得到缓解,而泡沫组为58%(35/60)(无显著差异:RR 1.27,95%CI 0.98至1.65)。在第二项研究中,腿部静脉溃疡患者100%(32/32)在治疗的第一个晚上使用布洛芬敷料后实现了某种程度的疼痛缓解,而当地最佳实践组为93%(26/28)(无显著差异:RR 1.08,95%CI 0.96至1.21)。将这些研究进行荟萃分析(使用随机效应模型,因为存在显著异质性(p = 0.1),I² = 64%),没有证据表明布洛芬敷料在使用的第一个晚上能增加疼痛缓解程度(RR 1.15,95%CI 0.91至1.44)。我们无法提取足够数据来合并这些试验的其他疼痛结局。愈合率没有差异,但与不含布洛芬的类似泡沫敷料相比,布洛芬敷料的不良事件略多。六项试验评估了与清创相关的疼痛干预措施,被认为足够相似可进行合并。使用5%利多卡因 - 丙胺卡因霜(复方利多卡因乳膏)进行清创时,疼痛评分有统计学上的显著降低;平均差异(在100毫米量表上测量)为20.6毫米(95%CI 12.19至29.11)。在这六项试验中,只有一项小型试验将愈合作为结局进行测量,发现在研究结束时愈合的溃疡数量没有差异。 作者结论:与泡沫敷料或最佳实践相比,没有证据表明布洛芬敷料在使用的第一个晚上能为患有疼痛性腿部静脉溃疡的患者缓解疼痛。复方利多卡因乳膏似乎能为腿部静脉溃疡清创提供有效的疼痛缓解,但复方利多卡因乳膏对溃疡愈合的影响(如果有)仍不清楚。
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