Bergin S M, Wraight P
Royal Melbourne Hospital, Departments of Diabetes & Clinical Epidemiology, Monash Institute of Health Services Research, Monash University, Grattan St, Parkville, Melbourne, Australia, 3050.
Cochrane Database Syst Rev. 2006 Jan 25(1):CD005082. doi: 10.1002/14651858.CD005082.pub2.
Foot ulceration affects 15-20% of people with diabetes. It is a major precursor to amputation in this patient group, and early and appropriate treatment provides the greatest opportunity for healing. The use of silver for its antimicrobial properties has re-emerged, and modern wound dressings that release a sustained amount of free silver ions, are now widely used in wound management.
To evaluate the effects of silver-containing dressings and topical agents on infection rates and healing of diabetes related foot ulcers.
Searches were made of the Cochrane Wounds Group Specialised Register (August 2005), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 3 2005) MEDLINE (1966 to October week 2 2004), EMBASE (1980 to October week 2 2004) and CINAHL (1982 to October week 2 2004). The Journal of Wound Care (Volume 12/13 Issues 1-10) was hand-searched. Manufacturers, researchers and local and international wound groups were contacted in order to identify unpublished trials. Web sites for wound groups and World Wide Wounds (www.worldwidewounds.com) were searched.
Randomised controlled trials and non-randomised controlled clinical trials were considered for inclusion. Studies were included if they involved participants with Type 1 or Type 2 diabetes and related foot ulcers, met the requirements for randomisation, allocation and concealment where appropriate, and compared the intervention with a placebo or a sham dressing, an alternative non silver based dressing or no dressing, and reported outcomes that represent healing rate or infection.
Two authors independently evaluated the papers identified by the search strategy against the inclusion criteria but identified no trials eligible for inclusion in the review. It was not possible to perform planned subgroup and sensitivity analysis in the absence of data. In future, if eligible trials become available, a random effects model will be applied for meta-analysis in the presence of statistical heterogeneity (estimated using the I(2) statistic). Dichotomous outcomes will be reported as risk ratios with 95% confidence intervals (CI), and continuous outcomes as weighted mean differences (WMD) with 95% CI. Statistical significance will be set at P value < 0.05 for all outcomes and the magnitude of the effect will be estimated by calculating the number needed to treat (NNT) with 95% CI.
No studies were identified that met with the inclusion criteria
AUTHORS' CONCLUSIONS: Despite the widespread use of dressings and topical agents containing silver for the treatment of diabetic foot ulcers, no randomised trials or controlled clinical trials exist that evaluate their clinical effectiveness. Trials are needed to determine clinical and cost-effectiveness and long term outcomes including adverse events.
足部溃疡影响15%至20%的糖尿病患者。它是该患者群体截肢的主要先兆，早期且恰当的治疗为愈合提供了最大机会。因银具有抗菌特性，其应用再度兴起，能持续释放游离银离子的现代伤口敷料现广泛用于伤口处理。
评估含银敷料和局部用药对糖尿病相关足部溃疡感染率及愈合情况的影响。
检索了Cochrane伤口组专业注册库（2005年8月）、Cochrane对照试验中央注册库（CENTRAL，《Cochrane图书馆》2005年第3期）、MEDLINE（1966年至2004年10月第2周）、EMBASE（1980年至2004年10月第2周）以及CINAHL（1982年至2004年10月第2周）。手工检索了《伤口护理杂志》（第12/13卷第1 - 10期）。联系了制造商、研究人员以及国内外伤口组织以识别未发表的试验。搜索了伤口组织网站和全球伤口网站（www.worldwidewounds.com）。
纳入随机对照试验和非随机对照临床试验。若研究涉及1型或2型糖尿病及相关足部溃疡患者，符合随机化、分配和隐匿的要求（如适用），并将干预措施与安慰剂、假敷料、非银基替代敷料或不使用敷料进行比较，且报告代表愈合率或感染情况的结果，则纳入研究。
两位作者根据入选标准独立评估检索策略所识别的论文，但未发现符合纳入综述标准的试验。因缺乏数据，无法进行计划中的亚组分析和敏感性分析。未来，若有符合条件的试验，在存在统计学异质性（使用I(2)统计量估计）时，将应用随机效应模型进行荟萃分析。二分结局将报告为风险比及95%置信区间（CI），连续结局报告为加权均数差（WMD）及95%CI。所有结局的统计学显著性设定为P值<0.05，效应大小将通过计算治疗所需人数（NNT）及95%CI来估计。
未识别出符合入选标准的研究。
尽管含银敷料和局部用药广泛用于治疗糖尿病足溃疡，但尚无评估其临床疗效的随机试验或对照临床试验。需要进行试验以确定临床疗效和成本效益以及包括不良事件在内的长期结局。
