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LL-37 乳膏促进糖尿病足溃疡愈合的疗效:一项随机双盲对照试验。

Efficacy of LL-37 cream in enhancing healing of diabetic foot ulcer: a randomized double-blind controlled trial.

机构信息

Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.

Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.

出版信息

Arch Dermatol Res. 2023 Nov;315(9):2623-2633. doi: 10.1007/s00403-023-02657-8. Epub 2023 Jul 22.

DOI:10.1007/s00403-023-02657-8
PMID:37480520
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10514151/
Abstract

Wound healing in DFU (diabetic foot ulcer) has prolonged inflammation phase and defective granulation tissue formation. LL-37 has antimicrobial property, induces angiogenesis, and keratinocyte migration and proliferation. This study analyzes the efficacy of LL-37 cream in enhancing wound healing rate and decreasing the levels of IL-1α, TNF-α, and the number of aerobic bacteria colonization in DFU with mild infection. This study was conducted from January 2020 to June 2021 in Jakarta. Subjects were instructed to apply either LL-37 cream or placebo cream twice a week for 4 weeks. Wounds were measured on days 7, 14, 21, and 28 and processed with ImageJ. The levels of LL-37, IL-1α, and TNF-α from wound fluid were measured using ELISA. The number of aerobic bacteria colonization was counted from the isolate grown in culture. The levels of LL-37 in DFU at baseline were equally low in both groups which were 1.07 (0.37-4.96) ng/mg protein in the LL-37 group and 1.11 (0.24-2.09) ng/mg protein in the placebo group. The increase in granulation index was consistently greater in the LL-37 group on days 7, 14, 21, and 28 (p = 0.031, 0.009, 0.006, and 0.037, respectively). The levels of IL-1α and TNF-α increased in both groups on days 14 and 21 (p > 0.05). The decrease in the number of aerobic bacteria colonization was greater in the LL-37 group on days 7, 14 and 21, but greater in the placebo group on day 28 (p > 0.05). In conclusion, LL-37 cream enhanced the healing rate of DFU with mild infection, but did not decrease the levels of IL-1α and TNF-α and the number of aerobic bacteria colonization. This trial is registered at ClinicalTrials.gov, number NCT04098562.

摘要

糖尿病足溃疡(DFU)的伤口愈合过程中炎症期延长,肉芽组织形成受损。LL-37 具有抗菌特性,可诱导血管生成以及角质形成细胞的迁移和增殖。本研究分析了轻度感染的 DFU 中使用 LL-37 乳膏对提高愈合率和降低白细胞介素-1α(IL-1α)、肿瘤坏死因子-α(TNF-α)水平以及需氧菌定植数量的疗效。这项研究于 2020 年 1 月至 2021 年 6 月在雅加达进行。参与者被指示每周两次涂抹 LL-37 乳膏或安慰剂乳膏,持续 4 周。在第 7、14、21 和 28 天测量伤口,并使用 ImageJ 进行处理。使用 ELISA 测量伤口液中的 LL-37、IL-1α 和 TNF-α 水平。从培养物中生长的分离株中计数需氧菌定植的数量。DFU 中 LL-37 的基线水平在两组中均较低,LL-37 组为 1.07(0.37-4.96)ng/mg 蛋白,安慰剂组为 1.11(0.24-2.09)ng/mg 蛋白。在第 7、14、21 和 28 天,LL-37 组的肉芽指数增加一直更大(p=0.031、0.009、0.006 和 0.037)。两组的 IL-1α 和 TNF-α 水平在第 14 和 21 天增加(p>0.05)。在第 7、14 和 21 天,LL-37 组的需氧菌定植数量减少更多,但在第 28 天,安慰剂组减少更多(p>0.05)。总之,LL-37 乳膏可提高轻度感染的 DFU 的愈合率,但并未降低 IL-1α 和 TNF-α 水平以及需氧菌定植数量。该试验在 ClinicalTrials.gov 注册,编号为 NCT04098562。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/844b/10514151/9163b05983f9/403_2023_2657_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/844b/10514151/34b23917157d/403_2023_2657_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/844b/10514151/214091832d9e/403_2023_2657_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/844b/10514151/bd94cc9bf431/403_2023_2657_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/844b/10514151/9163b05983f9/403_2023_2657_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/844b/10514151/34b23917157d/403_2023_2657_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/844b/10514151/214091832d9e/403_2023_2657_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/844b/10514151/bd94cc9bf431/403_2023_2657_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/844b/10514151/9163b05983f9/403_2023_2657_Fig4_HTML.jpg

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