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所有藻酸盐敷料都等效吗?

Are All Alginate Dressings Equivalent?

作者信息

Duciel Laura, Proust Richard, Ponsen Anne-Charlotte, Ziarelli Fabio, Coudreuse Arnaud, Jeanmichel Laurence, Samardzic Marina, Uzan Georges, des Courtils Céline

机构信息

Laboratoires Brothier, Nanterre, France.

INSERM UMRS-MD 1197, Université Paris-Saclay, Institut André Lwoff, Hôpital Paul Brousse, Villejuif, France.

出版信息

J Biomed Mater Res B Appl Biomater. 2025 Mar;113(3):e35557. doi: 10.1002/jbm.b.35557.

Abstract

Alginate dressings are widely used in wound treatment for their healing and hemostatic properties and their capacity to drain exudate. However, a clear understanding of the heterogeneity within this class of dressings is lacking. Numerous sources of variability exist between alginate dressings: their composition (% of calcium alginate relative to other components), the ratio of D-Mannuronic and L-Guluronic acids in the alginate fraction, their purity (presence of toxic contaminants), and the shape of their fibers (surface and thickness). These parameters affect the performance and safety of alginate dressings, which may thus not be interchangeable in clinical practice. Therefore, clinicians must be aware of these differences to ensure optimal treatment and avoid complications or suboptimal healing. The objective of this study was to compare six alginate dressings to conclude or not on their equivalence. The results obtained demonstrate considerable variability between alginate dressings in the assessed characteristics: composition, Ca release, level of cytotoxicity, fiber shape, draining capacity, and their resistance to traction. Algostéril, the only pure calcium alginate rich in G, releases a specific dose of Ca and is the only non-cytotoxic dressing. With its multilobed fibers that are statistically the thickest, it provides the best draining capacity and greatest resistance to traction. These results demonstrate that alginate dressings are not equivalent. Each dressing is distinct, and consequently the clinical performance of one cannot be transposed to the others. Therefore, each alginate dressing should demonstrate its own efficacy, in a given indication, through a clinical trial.

摘要

藻酸盐敷料因其愈合和止血特性以及引流渗出液的能力而被广泛用于伤口治疗。然而,目前尚缺乏对这类敷料异质性的清晰认识。藻酸盐敷料之间存在多种变异性来源:它们的组成(海藻酸钙相对于其他成分的百分比)、藻酸盐部分中D-甘露糖醛酸和L-古洛糖醛酸的比例、纯度(有毒污染物的存在)以及纤维形状(表面和厚度)。这些参数会影响藻酸盐敷料的性能和安全性,因此在临床实践中它们可能无法相互替换。所以,临床医生必须了解这些差异,以确保最佳治疗效果并避免并发症或愈合不佳。本研究的目的是比较六种藻酸盐敷料,以判断它们是否等效。所获得的结果表明,藻酸盐敷料在所评估的特性方面存在相当大的变异性:组成、钙释放、细胞毒性水平、纤维形状、引流能力以及它们的抗拉伸性。Algostéril是唯一富含G的纯海藻酸钙,会释放特定剂量的钙,并且是唯一无细胞毒性的敷料。其多叶状纤维在统计学上是最厚的,具有最佳的引流能力和最大的抗拉伸性。这些结果表明藻酸盐敷料并不等效。每种敷料都有其独特之处,因此一种敷料的临床性能不能直接套用到其他敷料上。所以,每种藻酸盐敷料都应在特定适应症中通过临床试验来证明自身的疗效。

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