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用于治疗下肢静脉性溃疡的含银抗菌敷料的随机对照试验及成本效益分析(VULCAN试验)

Randomized controlled trial and cost-effectiveness analysis of silver-donating antimicrobial dressings for venous leg ulcers (VULCAN trial).

作者信息

Michaels J A, Campbell B, King B, Palfreyman S J, Shackley P, Stevenson M

机构信息

Sheffield Vascular Institute, Northern General Hospital, Sheffield, UK.

出版信息

Br J Surg. 2009 Oct;96(10):1147-56. doi: 10.1002/bjs.6786.

DOI:10.1002/bjs.6786
PMID:19787753
Abstract

BACKGROUND

Antimicrobial silver dressings are used beneath graduated compression in the treatment of venous ulceration. There is little information on whether their use is effective. This was a prospective randomized trial and cost-effectiveness analysis of silver-donating versus non-silver low-adherence dressings in the treatment of venous leg ulcers.

METHODS

Patients were randomized between the two types of dressing. The primary outcome measure was complete ulcer healing at 12 weeks. Secondary outcomes included time to healing, quality of life and cost-effectiveness.

RESULTS

A total of 213 patients were recruited. There was no difference between the dressings in the proportion of ulcers healed at 12 weeks (59.6 per cent for silver and 56.7 per cent for control dressings). Mean utility scores for the EuroQol 5D and Short Form 6D were similar in both groups at 1, 3, 6 and 12 months. Compared with the control group the antimicrobial group had an incremental cost of pounds sterling 97.85 and an incremental quality-adjusted life year gain of 0.0002, giving an incremental cost-effectiveness ratio of pounds sterling 489 250 for the antimicrobial dressings.

CONCLUSION

No significant differences were found in either primary or secondary endpoints. There was no evidence to support the routine use of silver-donating dressings beneath compression for venous ulceration.

REGISTRATION NUMBER

ISRCTN 72485131 (http://www.controlled-trials.com).

摘要

背景

抗菌银敷料用于分级加压治疗下肢静脉溃疡。关于其使用是否有效,相关信息较少。这是一项关于含银敷料与不含银低粘附敷料治疗下肢静脉溃疡的前瞻性随机试验及成本效益分析。

方法

患者被随机分配使用两种类型的敷料。主要结局指标是12周时溃疡完全愈合。次要结局包括愈合时间、生活质量和成本效益。

结果

共招募了213名患者。两种敷料在12周时溃疡愈合比例方面无差异(含银敷料为59.6%,对照敷料为56.7%)。在1、3、6和12个月时,两组欧洲五维健康量表(EuroQol 5D)和简式健康调查简表6D(Short Form 6D)的平均效用得分相似。与对照组相比,抗菌组的增量成本为97.85英镑,增量质量调整生命年增益为0.0002,抗菌敷料的增量成本效益比为489250英镑。

结论

在主要或次要终点方面均未发现显著差异。没有证据支持在加压治疗下肢静脉溃疡时常规使用含银敷料。

注册号

ISRCTN 72485131(http://www.controlled-trials.com)

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