Department of Geriatry, Dermatology and Wound Healing Department, Rothschild University Hospital, Paris, France.
Dermatology and Vascular Medicine Department, Tenon University Hospital, Paris, France.
J Wound Care. 2024 Sep 2;33(9):678-686. doi: 10.12968/jowc.2024.0189.
Multicomponent bandages (MCBs) are recommended by the French Authority for Health (Haute Autorité de Santé) as first-line treatment for venous leg ulcers (VLUs). A first analysis of the data collected from the French administrative healthcare database (Système National des Données de Santé (SNDS)) on 25,255 patients with a VLU supported superiority of MCBs versus short stretch bandages when considering the healing outcomes and costs associated with closure of these wounds. The aim of this study was to assess how beneficial the primary dressing (technology lipido-colloid nano-oligosaccharide factor (TLC NOSF) or control dressing group (CDG)) could be, when used in combination with MCBs in the treatment of VLUs.
Data from the SNDS were collected for patients meeting the following inclusion criteria: treatment for a VLU with MCBs and with the same dressing type (TLC-NOSF or CDG) during the whole treatment period. Healing outcomes were documented on the global cohorts and propensity score-matched cohorts. The mean healthcare cost and the ecological impact were calculated for those patients healed within the study period.
In total, 12,507 patients met the criteria for treatment with both MCBs and TLC-NOSF dressings (n=1134) versus MCBs and CDG (n=11,373); with 1134 and 2268 patients per group following propensity score matching. Healing outcomes were favourable for the TLC-NOSF group in the global cohort and were enhanced in the propensity score-matched cohorts. At every point of the analysis, the adjusted healing rates were significantly higher in the TLC-NOSF group than in the CDG group (p<0.001). In the propensity score-matched cohorts (n=3402), the healing rate at three months was 52% in the TLC-NOSF group versus 37% in the CDG group (p<0.001). The median healing time was 87 days versus 125.5 days in the TLC-NOSF and CDG groups, respectively (p<0.0001). TLC-NOSF dressings significantly reduced the average treatment cost per healed ulcer (€2099) by 23.7% compared with dressings without TLC-NOSF (€2751) (p<0.001), as well as the resources used.
This SNDS analysis confirms, in the largest real-life study performed in VLU management, the superiority of the TLC-NOSF dressings versus those not impregnated with the NOSF compound. Better clinical outcomes associated with cost savings and a positive ecological impact support the combination of MCBs and TLC-NOSF dressings and should be considered as an optimal standard of care for the global management of VLUs. These outcomes reinforce the current positions of the international guidelines on the use of NOSF impregnated dressings (UrgoStart range; Laboratoires Urgo, France) in this pathology.
法国卫生署(Haute Autorité de Santé)建议将多组分绷带(MCB)作为静脉性腿部溃疡(VLU)的一线治疗方法。对从法国行政医疗保健数据库(Système National des Données de Santé(SNDS))收集的 25,255 例 VLUs 患者的数据进行的首次分析表明,在考虑这些伤口愈合结果和与闭合相关的成本时,MCB 优于短拉伸绷带。本研究的目的是评估在治疗 VLUs 时,主要敷料(脂质胶体纳米寡糖因子(TLC NOSF)或对照敷料组(CDG))与 MCB 联合使用时的有益程度。
SNDS 数据收集符合以下纳入标准的患者:使用 MCB 治疗 VLU,且整个治疗期间使用相同的敷料类型(TLC-NOSF 或 CDG)。在全球队列和倾向评分匹配队列中记录愈合结果。对于在研究期间内治愈的患者,计算平均医疗保健成本和生态影响。
共有 12,507 例患者符合同时使用 MCB 和 TLC-NOSF 敷料(n=1134)与 MCB 和 CDG(n=11,373)治疗的标准;每组有 1134 例和 2268 例患者进行倾向评分匹配。在全球队列中,TLC-NOSF 组的愈合结果良好,在倾向评分匹配队列中得到了增强。在分析的每个时间点,TLC-NOSF 组的调整愈合率均显著高于 CDG 组(p<0.001)。在倾向评分匹配队列(n=3402)中,TLC-NOSF 组三个月时的愈合率为 52%,CDG 组为 37%(p<0.001)。TLC-NOSF 组的中位愈合时间为 87 天,而 CDG 组为 125.5 天(p<0.0001)。与不含 TLC-NOSF 的敷料相比(€2751),TLC-NOSF 敷料可显著降低每个治愈溃疡的平均治疗成本(€2099),(p<0.001),以及使用的资源。
这项 SNDS 分析在 VLUs 管理中进行的最大真实世界研究中证实,TLC-NOSF 敷料优于未浸渍 NOSF 化合物的敷料。更好的临床结果与成本节约和积极的生态影响相关,支持 MCB 和 TLC-NOSF 敷料的联合使用,并应被视为 VLUs 全球管理的最佳护理标准。这些结果加强了国际指南在该病理学中使用浸渍 NOSF 的敷料(UrgoStart 系列;Laboratoires Urgo,法国)的当前立场。