Nelson E A, Bradley M D
University of Leeds, School of Healthcare, Baines Wing, Leeds, UK, LS2 9UT.
Cochrane Database Syst Rev. 2007 Jan 24(1):CD001836. doi: 10.1002/14651858.CD001836.pub2.
It is estimated that people in industrialised countries have a 1% chance of suffering from a leg ulcer at some time in their life. The majority of leg ulcers are associated with circulation problems; poor blood return in the veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the legs causes arterial ulcers (around 25% of ulcers). Treatment of arterial leg ulcers is directed towards correcting the poor arterial blood supply, for example, by surgically correcting arterial blockages, and by supporting ulcer healing using topical agents (medicines in cream/ointment) and wound dressings. There are a large number of topical agents and wound dressings available and it is unclear what impact these have on ulcer healing.
To determine whether topical agents and wound dressings affect the rate of healing in arterial ulcers. To compare healing rates, costs and patient-centred outcomes between wound dressings and topical agents.
Potential trials were sought through the Specialised Trials Registers of the Cochrane Wounds Group (last searched April 2002), the Cochrane Peripheral Vascular Diseases Group (last searched November 2006) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, Issue 4, 2006
Randomised controlled trials (RCTs), or controlled clinical trials (CCTs) of dressings and topical agents for arterial leg ulcers were eligible for inclusion. The participants had to have ulcers that were described as arterial, and the time to healing, proportion completely healed, or rate of reduction in ulcer area had to be reported. All wound dressings and topical agents were eligible for inclusion in this review.
Information on the participants' characteristics, the interventions, and outcomes, as well as data on the trial methods, such as blinding of patients and clinicians, and allocation concealment were extracted using a standardised data extraction form.
One trial met the inclusion criteria. This small trial compared ketanserin ointment with vehicle alone, changed twice a day. The trial was too small and for too short a follow-up period to be able to determine whether there was any difference in healing rates.
AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers. Inadequate description of the people in the one included trial means that the results cannot be easily applied to other clinical populations.
据估计,工业化国家的人们一生中患腿部溃疡的几率为1%。大多数腿部溃疡与循环问题有关;静脉血液回流不畅会导致静脉溃疡(约占溃疡的70%),腿部血液供应不足会导致动脉溃疡(约占溃疡的25%)。动脉性腿部溃疡的治疗旨在纠正动脉血液供应不足,例如通过手术纠正动脉阻塞,并使用局部用药(乳膏/软膏中的药物)和伤口敷料来促进溃疡愈合。有大量的局部用药和伤口敷料可供选择,目前尚不清楚它们对溃疡愈合有何影响。
确定局部用药和伤口敷料是否会影响动脉溃疡的愈合速度。比较伤口敷料和局部用药之间的愈合速度、成本及以患者为中心的结局。
通过Cochrane伤口小组专业试验注册库(最后检索时间为2002年4月)、Cochrane外周血管疾病小组(最后检索时间为2006年11月)以及Cochrane图书馆2006年第4期的Cochrane对照试验中心注册库(CENTRAL)检索潜在的试验。
动脉性腿部溃疡敷料和局部用药的随机对照试验(RCT)或对照临床试验(CCT)符合纳入标准。参与者必须患有被描述为动脉性的溃疡,且必须报告愈合时间、完全愈合的比例或溃疡面积缩小率。所有伤口敷料和局部用药均符合本综述的纳入标准。
使用标准化的数据提取表提取有关参与者特征、干预措施和结局的信息,以及有关试验方法的数据,如患者和临床医生的盲法以及分配隐藏。
一项试验符合纳入标准。这项小型试验将酮色林软膏与仅使用赋形剂进行比较,每天更换两次。该试验规模太小且随访期过短,无法确定愈合速度是否存在差异。
没有足够的证据来确定局部用药或敷料的选择是否会影响动脉性腿部溃疡的愈合。纳入的一项试验对研究对象的描述不充分,这意味着研究结果不易应用于其他临床人群。