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同时使用肝素通过碱性成纤维细胞生长因子促进皮肤移植供区愈合:一项前瞻性随机对照试验研究

Concomitant heparin use promotes skin graft donor site healing by basic fibroblast growth factor: A pilot prospective randomized controlled study.

作者信息

Kohyama Keishi, Kato Hisakazu, Okada Hideshi, Ishihara Takuma, Yasue Yuji, Kamidani Ryo, Suzuki Kodai, Miyake Takahito, Okuda Hiroshi, Shibata Hirofumi, Tomita Hiroyuki, Ogawa Takenori

机构信息

Department of Plastic and Reconstructive Surgery, Gifu University Hospital, Gifu, Japan.

Department of Emergency and Disaster Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.

出版信息

Contemp Clin Trials Commun. 2024 Sep 24;42:101375. doi: 10.1016/j.conctc.2024.101375. eCollection 2024 Dec.

Abstract

Owing to its mitogenic and angiogenic characteristics, the use of basic fibroblast growth factor (bFGF) to promote wound healing has been investigated. However, its clinical efficacy has fallen short of expectations due to its instability. Heparin has been reported to stabilize bFGF. Therefore, we hypothesized that the combination of these agents would more effectively promote wound healing than bFGF alone; a single-center, two-arm parallel, single-blind, and a prospective randomized controlled pilot study was therefore performed involving 12 patients who underwent split-thickness skin graft harvesting. To ensure a feasible clinical treatment model, commercially available agents were used. The patients were randomly assigned to either the control group treated with bFGF (n = 6) or the intervention group treated with bFGF and heparin (n = 6) in a 1:1 ratio. The wound area and the wound area variation was assessed each week postoperatively, as was the number of days required for epithelialization. As a supplementary analysis, the least-squares means were calculated using a linear mixed-effects model. The results of this study indicate that the combination of bFGF and heparin may more effectively promote wound healing than bFGF alone, consistent with our hypothesis. A multicenter trial based on these data is ongoing.

摘要

由于其促有丝分裂和血管生成特性,人们已对使用碱性成纤维细胞生长因子(bFGF)促进伤口愈合展开研究。然而,由于其不稳定性,其临床疗效未达预期。据报道,肝素可使bFGF稳定。因此,我们推测这些药物联合使用比单独使用bFGF能更有效地促进伤口愈合;因此,我们开展了一项单中心、双臂平行、单盲的前瞻性随机对照试验性研究,纳入12例行中厚皮片取皮术的患者。为确保临床治疗模式可行,使用了市售药物。患者按1:1比例随机分为接受bFGF治疗的对照组(n = 6)或接受bFGF与肝素联合治疗的干预组(n = 6)。术后每周评估伤口面积和伤口面积变化,以及上皮化所需天数。作为补充分析,使用线性混合效应模型计算最小二乘均值。本研究结果表明,bFGF与肝素联合使用可能比单独使用bFGF更有效地促进伤口愈合,这与我们的假设一致。基于这些数据的多中心试验正在进行中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f7c/11470421/24ec8690109d/gr1.jpg

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