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Dressings and topical agents for treating pressure ulcers

机译:用于治疗压疮的敷料和外用剂

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摘要

Background Pressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are localised areas of injury to the skin or the underlying tissue, or both. Dressings are widely used to treat pressure ulcers and promote healing, and there are many options to choose from including alginate, hydrocolloid and protease-modulating dressings. Topical agents have also been used as alternatives to dressings in order to promote healing. A clear and current overview of all the evidence is required to facilitate decision-making regarding the use of dressings or topical agents for the treatment of pressure ulcers. Such a review would ideally help people with pressure ulcers and health professionals assess the best treatment options. This review is a network meta-analysis (NMA) which assesses the probability of complete ulcer healing associated with alternative dressings and topical agents. Objectives To assess the effects of dressings and topical agents for healing pressure ulcers in any care setting. We aimed to examine this evidence base as a whole, determining probabilities that each treatment is the best, with full assessment of uncertainty and evidence quality. Search methods In July 2016 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses, guidelines and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria Published or unpublished randomised controlled trials (RCTs) comparing the effects of at least one of the following interventions with any other intervention in the treatment of pressure ulcers (Stage 2 or above): any dressing, or any topical agent applied directly to an open pressure ulcer and left in situ. We excluded from this review dressings attached to external devices such as negative pressure wound therapies, skin grafts, growth factor treatments, platelet gels and larval therapy. Data collection and analysis Two review authors independently performed study selection, risk of bias assessment and data extraction. We conducted network meta-analysis using frequentist mega-regression methods for the efficacy outcome, probability of complete healing. We modelled the relative effectiveness of any two treatments as a function of each treatment relative to the reference treatment (saline gauze). We assumed that treatment effects were similar within dressings classes (e.g. hydrocolloid, foam). We present estimates of effect with their 95% confidence intervals for individual treatments compared with every other, and we report ranking probabilities for each intervention (probability of being the best, second best, etc treatment). We assessed the certainty (quality) of the body of evidence using GRADE for each network comparison and for the network as whole. Main results We included 51 studies (2947 participants) in this review and carried out NMA in a network of linked interventions for the sole outcome of probability of complete healing. The network included 21 different interventions (13 dressings, 6 topical agents and 2 supplementary linking interventions) and was informed by 39 studies in 2127 participants, of whom 783 had completely healed wounds. We judged the network to be sparse: overall, there were relatively few participants, with few events, both for the number of interventions and the number of mixed treatment contrasts; most studies were small or very small. The consequence of this sparseness is high imprecision in the evidence, and this, coupled with the (mainly) high risk of bias in the studies informing the network, means that we judged the vast majority of the evidence to be of low or very low certainty. We have no confidence in the findings regarding the rank order of interventions in this review (very low-certainty evidence), but we report here a summary of results for some comparisons of interventions compared with saline gauze. We present here only the findings from evidence which we did not consider to be very low certainty, but these reported results should still be interpreted in the context of the very low certainty of the network as a whole. It is not clear whether regimens involving protease-modulating dressings increase the probability of pressure ulcer healing compared with saline gauze (risk ratio (RR) 1.65, 95% confidence interval (CI) 0.92 to 2.94) (moderate-certainty evidence: low risk of bias, downgraded for imprecision). This risk ratio of 1.65 corresponds to an absolute difference of 102 more people healed with protease modulating dressings per 1000 people treated than with saline gauze alone (95% CI 13 fewer to 302 more). It is unclear whether the following interventions increase the probability of healing compared with saline gauze (low-certainty evidence): collagenase ointment (RR 2.12, 95% CI 1.06 to 4.22); foam dressings (RR 1.52, 95% CI 1.03 to 2.26); basic wound contact dressings (RR 1.30, 95% CI 0.65 to 2.58) and polyvinylpyrrolidone plus zinc oxide (RR 1.31, 95% CI 0.37 to 4.62); the latter two interventions both had confidence intervals consistent with both a clinically important benefit and a clinically important harm, and the former two interventions each had high risk of bias as well as imprecision. Authors' conclusions A network meta-analysis (NMA) of data from 39 studies (evaluating 21 dressings and topical agents for pressure ulcers) is sparse and the evidence is of low or very low certainty (due mainly to risk of bias and imprecision). Consequently we are unable to determine which dressings or topical agents are the most likely to heal pressure ulcers, and it is generally unclear whether the treatments examined are more effective than saline gauze. More research is needed to determine whether particular dressings or topical agents improve the probability of healing of pressure ulcers. The NMA is uninformative regarding which interventions might best be included in a large trial, and it may be that research is directed towards prevention, leaving clinicians to decide which treatment to use on the basis of wound symptoms, clinical experience, patient preference and cost.
机译:背景技术压疮,也称为褥疮,褥疮和压伤,是皮肤或下层组织或两者的局部损伤区域。敷料被广泛用于治疗压力性溃疡并促进愈合,并且有许多选择,包括藻酸盐,水胶体和调节蛋白酶的敷料。局部用药也已被用作敷料的替代品,以促进愈合。需要对所有证据进行清晰,最新的概述,以促进有关使用敷料或局部用药治疗压疮的决策。这样的审查将理想地帮助患有压疮的人和卫生专业人员评估最佳治疗方案。这项审查是网络荟萃分析(NMA),评估与替代敷料和局部用药相关的溃疡完全愈合的可能性。目的评估敷料和局部用药在任何护理环境中对治疗压力性溃疡的作用。我们的目标是从整体上检查该证据基础,确定每种疗法最佳的可能性,并全面评估不确定性和证据质量。检索方法2016年7月,我们检索了Cochrane伤口专业登记册;科克伦对照试验中央注册簿(CENTRAL); Ovid MEDLINE; Ovid MEDLINE(进行中的和其他非索引引文); Ovid Embase和EBSCO CINAHL Plus。我们还搜索了正在进行中的和未发表的研究的临床试验注册管理机构,并扫描了相关纳入研究的参考清单以及评论,荟萃分析,指南和健康技术报告,以识别其他研究。语言,出版日期或学习环境没有任何限制。选择标准比较以下至少一项干预措施与任何其他干预措施治疗压疮的效果(2期或以上)的已发表或未发表的随机对照试验(RCT):将任何敷料或任何局部用药直接应用于治疗开放性溃疡并留在原位。我们从本评价中排除了与外部设备(如负压伤口治疗,皮肤移植,生长因子治疗,血小板凝胶和幼虫治疗)相连的敷料。数据收集和分析两名评价作者独立进行研究选择,偏倚评估风险和数据提取。我们使用频繁兆回归分析进行网络荟萃分析,以了解疗效结果和完全治愈的可能性。我们对两种治疗相对于参考治疗(盐水纱布)的功能进行了建模。我们假设在敷料类别中(例如水胶体,泡沫)治疗效果相似。我们以95%的置信区间对每种疗法的效果进行估算,并将其与其他疗法进行比较,并报告每种干预措施的排名概率(最佳,第二等疗法的概率)。对于每个网络比较以及整个网络,我们使用GRADE评估了证据主体的确定性(质量)。主要结果我们纳入了51项研究(2947名参与者),并在相关干预网络中对NMA进行了NMA检查,以得出完全治愈的唯一可能性。该网络包括21种不同的干预措施(13种敷料,6种局部用药和2种辅助性链接干预措施),并得到2127名参与者的39项研究的指导,其中783例伤口完全愈合。我们认为该网络是稀疏的:总体而言,干预的数量和混合治疗的对比数量相对较少,事件也很少。大多数研究很小或很小。稀疏的结果是证据中的不精确性,再加上(主要)在通知网络的研究中存在偏见的高风险,这意味着我们认为绝大多数证据的确定性很低或非常低。 。我们对本评价中干预措施的排名结果没有信心(非常不确定的证据),但是我们在此报告了与盐水纱布进行的一些干预措施比较的结果摘要。在这里,我们仅介绍我们认为不是非常低的确定性的证据发现,但是仍应在整个网络的非常低确定性的背景下解释这些报告的结果。尚不清楚与盐水纱布相比,涉及蛋白酶调节敷料的治疗方案是否会增加压力性溃疡愈合的可能性(风险比(RR)1.65,95%置信区间(CI)0.92至2.94)(中度确证:低风险)偏压,由于不精确而降级)。该风险比1.65对应于绝对的差异,与单独使用生理盐水纱布相比,每1000人中用蛋白酶调节敷料治愈的人多102个人(95%CI 13减少至302多)。目前尚不清楚与盐水纱布相比,以下干预措施是否会增加治愈的可能性(低确定性证据):胶原酶软膏(RR 2.12,95%CI 1.06至4.22);泡沫敷料(RR 1.52,95%CI 1.03至2.26);基本伤口接触敷料(RR 1.30,95%CI 0.65至2.58)和聚乙烯吡咯烷酮加氧化锌(RR 1.31,95%CI 0.37至4.62);后两种干预措施的置信区间均与临床上重要的益处和临床上的重大危害相一致,前两种干预措施均具有偏见和不精确的高风险。作者的结论来自39项研究(评估21种压疮敷料和局部用药)的数据的网络荟萃分析(NMA)很少,证据的确定性很低或非常低(主要是由于偏倚和不精确的风险)。因此,我们无法确定最可能治愈压力性溃疡的敷料或局部用药,并且通常不清楚所检查的治疗方法是否比生理盐水纱布更有效。需要更多的研究来确定特定的敷料或局部用药是否能改善压力性溃疡愈合的可能性。 NMA没有提供关于哪种干预措施最好包括在大型试验中的信息,并且可能是针对预防的研究,因此临床医生可以根据伤口症状,临床经验,患者的喜好和费用来决定使用哪种治疗方法。

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