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自体浓缩生长因子在组织扩张过程中增加皮肤厚度和面积:一项随机临床试验。

Autologous Concentrated Growth Factor Increases Skin Thickness and Area during Tissue Expansion: A Randomized Clinical Trial.

机构信息

From the Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine.

出版信息

Plast Reconstr Surg. 2023 Aug 1;152(2):281e-292e. doi: 10.1097/PRS.0000000000010227. Epub 2023 Jan 24.

DOI:10.1097/PRS.0000000000010227
PMID:36727707
Abstract

BACKGROUND

Mechanical stretching of the skin (ie, tissue expansion) could generate additional skin, but it is limited by the intrinsic growth capacity. The authors conducted a study of autologous concentrated growth factor (CGF) to promote skin regeneration by increasing skin thickness and area during tissue expansion.

METHODS

A single-center randomized controlled trial was conducted from 2016 to 2019. Participants undergoing skin expansion received either CGF or saline by means of intradermal injection on the expanded skin (0.02 mL/cm 2 ), for a total of three treatments at 4-week intervals. The primary endpoint was the expanded skin thickness at 12 weeks, which was measured by ultrasound. The secondary endpoints included skin thickness at 4 and 8 weeks and surface area, expansion index, and skin texture score of the expanded skin at 12 weeks. Safety assessments, for infection symptoms and nodule formation, were assessed at 24 weeks.

RESULTS

In total, 26 patients were enrolled and assigned to the CGF or control group. Compared with the control group, the CGF group had significantly increased skin thickness at 8 (control, 1.1 ± 0.1 mm; CGF, 1.4 ± 0.1 mm; -0.6 to 0.0 mm; P = 0.047) and 12 weeks (control, 1.0 ± 0.1 mm; CGF, 1.3 ± 0.1 mm; -0.6 to 0.0 mm; P = 0.047). Compared with the baseline thickness (control, 1.6 ± 0.1 mm; CGF, 1.5 ± 0.1 mm; -0.3 to 0.5 mm; P = 0.987), skin thickness was sustained in the CGF group at 8 weeks after treatment (-0.1 to 0.3 mm; P = 0.711) but decreased in the control group (0.3 to 0.7 mm; P < 0.001). At 12 weeks, the CGF group showed greater increases in surface area (control, 77.7 ± 18.5 cm 2 ; CGF, 135.0 ± 15.7 cm 2 ; 7.2 cm 2 to 107.4 cm 2 ; P = 0.027) and expansion index (control, 0.9 ± 0.1; CGF, 1.4 ± 0.2; 0.0 to 0.8; P = 0.030) than the control group. In addition, CGF-treated skin showed an improvement in texture [CGF: grade 3, n = 2 (15.8%), grade 2, n = 4 (30.7%); control: grade 3, n = 0 (0.0%), grade 2, n = 3 (23.0%)]. No severe adverse events occurred.

CONCLUSION

CGF treatment increases skin thickness and area during tissue expansion, and represents a safe and effective strategy for managing skin expansion.

CLINICAL RELEVANCE STATEMENT

The findings of this study indicate that it is practically feasible to improve skin regeneration by applying autologous platelet concentrate therapy for skin expansion management.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

摘要

背景

皮肤的机械拉伸(即组织扩张)可以产生额外的皮肤,但它受到内在生长能力的限制。作者进行了一项关于自体浓缩生长因子(CGF)的研究,通过增加组织扩张过程中的皮肤厚度和面积来促进皮肤再生。

方法

这是一项于 2016 年至 2019 年进行的单中心随机对照试验。接受皮肤扩张的参与者在扩张的皮肤上通过皮内注射接受 CGF 或生理盐水(0.02 毫升/平方厘米),每 4 周共进行 3 次治疗。主要终点是 12 周时的扩张皮肤厚度,通过超声测量。次要终点包括 4 周和 8 周时的皮肤厚度、12 周时的扩张皮肤表面积、扩张指数和皮肤纹理评分。在 24 周时评估安全性,包括感染症状和结节形成。

结果

共有 26 名患者入组并被分配到 CGF 或对照组。与对照组相比,CGF 组在 8 周(对照组,1.1±0.1 毫米;CGF 组,1.4±0.1 毫米;-0.6 至 0.0 毫米;P=0.047)和 12 周(对照组,1.0±0.1 毫米;CGF 组,1.3±0.1 毫米;-0.6 至 0.0 毫米;P=0.047)时皮肤厚度显著增加。与基线厚度(对照组,1.6±0.1 毫米;CGF 组,1.5±0.1 毫米;-0.3 至 0.5 毫米;P=0.987)相比,CGF 组在治疗后 8 周时皮肤厚度持续(-0.1 至 0.3 毫米;P=0.711),但对照组皮肤厚度减少(0.3 至 0.7 毫米;P<0.001)。在 12 周时,CGF 组的表面积增加更大(对照组,77.7±18.5 平方厘米;CGF 组,135.0±15.7 平方厘米;7.2 平方厘米至 107.4 平方厘米;P=0.027)和扩张指数(对照组,0.9±0.1;CGF 组,1.4±0.2;0.0 至 0.8;P=0.030)高于对照组。此外,CGF 治疗的皮肤纹理得到改善[CGF:3 级,n=2(15.8%),2 级,n=4(30.7%);对照组:3 级,n=0(0.0%),2 级,n=3(23.0%)]。未发生严重不良事件。

结论

CGF 治疗可在组织扩张过程中增加皮肤厚度和面积,是一种安全有效的管理皮肤扩张的策略。

临床意义

本研究结果表明,通过应用自体血小板浓缩物治疗来改善皮肤再生,在实践中是可行的。

临床问题/证据水平:治疗,II 级。

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