Moore Zena E H, Webster Joan
Faculty of Nursing and Midwifery, Royal College of Surgeons in Ireland, 123 St Stephens Green, Dublin, Ireland.
Cochrane Database Syst Rev. 2013 Aug 18(8):CD009362. doi: 10.1002/14651858.CD009362.pub2.
Pressure ulcers, which are localised injury to the skin, or underlying tissue or both, occur when people are unable to reposition themselves to relieve pressure on bony prominences. Pressure ulcers are often difficult to heal, painful and impact negatively on the individual's quality of life. The cost implications of pressure ulcer treatment are considerable, compounding the challenges in providing cost effective, efficient health services. Efforts to prevent the development of pressure ulcers have focused on nutritional support, pressure redistributing devices, turning regimes and the application of various topical agents and dressings designed to maintain healthy skin, relieve pressure and prevent shearing forces. Although products aimed at preventing pressure ulcers are widely used, it remains unclear which, if any, of these approaches are effective in preventing the development of pressure ulcers.
To evaluate the effects of dressings and topical agents on the prevention of pressure ulcers, in people of any age without existing pressure ulcers, but considered to be at risk of developing a pressure ulcer, in any healthcare setting.
In February 2013 we searched the following electronic databases to identify reports of relevant randomised clinical trials (RCTs): the Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Database of Abstracts of Reviews of Effects (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL.
We included RCTs evaluating the use of dressings, topical agents, or topical agents with dressings, compared with a different dressing, topical agent, or combined topical agent and dressing, or no intervention or standard care, with the aim of preventing the development of a pressure ulcer.
We assessed trials for their appropriateness for inclusion and for their risk of bias. This was done by two review authors working independently, using pre-determined inclusion and quality criteria.
Five trials (940 participants) of unclear or high risk of bias compared a topical agent with a placebo. Four of these trials randomised by individual and one by cluster. When results from the five trials were combined, the risk ratio (RR) was 0.78 (95% CI 0.47 to 1.31; P value 0.35) indicating no overall beneficial effect of the topical agents. When the cluster randomised trial was omitted from the analysis, use of topical agents reduced the pressure ulcer incidence by 36%; RR 0.64 (95% CI 0.49 to 0.83; P value 0.0008).Four trials (561 participants), all of which were of high or unclear risk of bias, showed that dressings applied over bony prominences reduced pressure ulcer incidence; RR 0.21 (95% CI 0.09 to 0.51; P value 0.0006).
AUTHORS' CONCLUSIONS: There is insufficient evidence from RCTs to support or refute the use of topical agents applied over bony prominences to prevent pressure ulcers. Although the incidence of pressure ulcers was reduced when dressings were used to protect the skin, results were compromised by the low quality of the included trials. These trials contained substantial risk of bias and clinical heterogeneity (variations in populations and interventions); consequently, results should be interpreted as inconclusive. Further well designed trials addressing important clinical, quality of life and economic outcomes are justified, based on the incidence of the problem and the high costs associated with pressure ulcer management.
压疮是皮肤、皮下组织或两者的局部损伤,当人们无法自行改变体位以减轻骨隆突处的压力时就会发生。压疮往往难以愈合,会带来疼痛,对个人生活质量产生负面影响。压疮治疗的成本相当高,这使得提供具有成本效益、高效的医疗服务面临更大挑战。预防压疮的努力主要集中在营养支持、压力再分布装置、翻身方案以及应用各种旨在保持皮肤健康、减轻压力和防止剪切力的外用药物和敷料。尽管旨在预防压疮的产品被广泛使用,但尚不清楚这些方法中哪些(如果有的话)在预防压疮方面有效。
评估敷料和外用药物对任何年龄、无现有压疮但被认为有发生压疮风险的人群在任何医疗环境中预防压疮的效果。
2013年2月,我们检索了以下电子数据库以识别相关随机临床试验(RCT)的报告:Cochrane伤口小组专业注册库;Cochrane对照试验中心注册库(CENTRAL)(Cochrane图书馆);疗效评价文摘数据库(Cochrane图书馆);Ovid MEDLINE;Ovid MEDLINE(在研及其他未索引引文);Ovid EMBASE;以及EBSCO CINAHL。
我们纳入了评估敷料、外用药物或外用药物与敷料联合使用,与不同敷料、外用药物或外用药物与敷料联合使用,或无干预或标准护理相比,旨在预防压疮发生的RCT。
我们评估试验是否适合纳入以及偏倚风险。这由两位综述作者独立进行,使用预先确定的纳入标准和质量标准。
五项偏倚风险不明确或较高的试验(940名参与者)将一种外用药物与安慰剂进行了比较。其中四项试验按个体随机分组,一项按整群随机分组。当将这五项试验的结果合并时,风险比(RR)为0.78(95%可信区间0.47至1.31;P值0.35),表明外用药物总体上没有有益效果。当在分析中排除整群随机试验时,外用药物的使用使压疮发生率降低了36%;RR为0.64(95%可信区间0.49至0.83;P值0.0008)。四项试验(561名参与者),所有这些试验的偏倚风险都较高或不明确,结果显示在骨隆突处应用敷料可降低压疮发生率;RR为0.21(95%可信区间0.09至0.51;P值0.0006)。
随机对照试验中没有足够证据支持或反驳在骨隆突处使用外用药物预防压疮。尽管使用敷料保护皮肤时压疮发生率有所降低,但纳入试验的低质量影响了结果。这些试验存在大量偏倚风险和临床异质性(人群和干预措施的差异);因此,结果应被视为不确定。鉴于该问题的发生率以及压疮管理相关的高成本,进一步开展设计良好的试验以解决重要的临床、生活质量和经济结果是合理的。