从概念热潮到循证证据导向：整形外科生物治疗应用与研究现状

doi:10.3969/j.issn.2095-378X.2026.03.001

摘要/Abstract

摘要： 整形外科治疗目标正由单纯形态修复逐渐转向组织质量改善、功能恢复和再生优化。近年来,脱细胞真皮基质、自体脂肪移植、富血小板血浆、浓缩生长因子、外泌体、脂肪来源基质血管成分及组织工程支架等生物治疗方式不断进入创面修复、瘢痕调控、放疗后软组织损伤修复、毛发修复、面部年轻化和软组织重建等临床场景。部分技术已形成相对稳定的应用经验,但更多新兴治疗仍面临产品定义不清、制备流程异质、适应证边界模糊、终点指标不统一及监管路径复杂等问题。本文结合整形外科修复需求和国内生物医学新技术管理要求,梳理主要生物治疗方式的应用现状,分析临床热度与证据积累之间的错位,并提出应围绕产品表征、适应证匹配、终点标准化、传统治疗整合和申报路径合规等方面推动其循证转化。

关键词: 整形外科, 生物治疗, 再生医学, 创面修复, 瘢痕, 临床转化

Abstract: The goals of plastic surgery are shifting from structural reconstruction alone toward improvement in tissue quality, functional restoration, and regenerative optimization. In recent years, biologic therapies, including acellular dermal matrix, autologous fat grafting, platelet-rich plasma, concentrated growth factors, extracellular vesicles, adipose-derived stromal vascular fraction, and tissue-engineered scaffolds, have been increasingly explored in wound repair, scar modulation, radiation-induced soft-tissue injury repair, hair restoration, facial rejuvenation, and soft-tissue reconstruction. Although several modalities have accumulated relatively mature clinical experience, many emerging interventions still face uncertainties in product definition, preparation heterogeneity, indication boundaries, outcome measures, and regulatory pathways. This article reviewed current applications of biologic therapies in plastic surgery, discussed the mismatch between clinical enthusiasm and evidence accumulation, and proposed that evidence-oriented translation should be guided by product characterization, indication-specific evaluation, standardized endpoints, integration with traditional plastic surgery treatments, and appropriate regulatory pathways.

Key words: Plastic surgery, Biologic therapy, Regenerative medicine, Wound repair, Scar, Clinical translation

中图分类号:

张晋, 周佳. 从概念热潮到循证证据导向：整形外科生物治疗应用与研究现状[J]. 外科研究与新技术（中英文）, 2026, 15(3): 195-200.

ZHANG Jin, ZHOU Jia. From conceptual enthusiasm to evidence-oriented practice： Applications and research status of biologic therapies in plastic surgery[J]. Surgical Research and New Technique, 2026, 15(3): 195-200.

参考文献

[1] Abu-Ghname A, Perdanasari AT, Reece EM.Principles and applications of fat grafting in plastic surgery[J]. Semin Plast Surg, 2019, 33(3): 147-154.
[2] Tonnard P, Verpaele A, Peeters G, et al.Nanofat grafting: basic research and clinical applications[J]. Plast Reconstr Surg, 2013, 132(4): 1017-1026.
[3] Meznerics FA, Fehérvári P, Dembrovszky F, et al.Platelet-rich plasma in chronic wound management: a systematic review and meta-analysis of randomized clinical trials[J]. J Clin Med, 2022, 11(24): 7532.
[4] Macadam SA, Lennox PA.Acellular dermal matrices: use in reconstructive and aesthetic breast surgery[J]. Can J Plast Surg, 2012, 20(2): 75-89.
[5] Sommeling CE, Heyneman A, Hoeksema H, et al.The use of platelet-rich plasma in plastic surgery: a systematic review[J]. J Plast Reconstr Aesthet Surg, 2013, 66(3): 301-311.
[6] McGraw IT, Wilson EE, Behfar A, et al. Evolving role of exosomes in plastic and reconstructive surgery and dermatology[J]. Plast Reconstr Surg Glob Open, 2024, 12(8): e6061.
[7] Gentile P, Scioli MG, Bielli A, et al.Concise review: the use of adipose-derived stromal vascular fraction cells and platelet rich plasma in regenerative plastic surgery[J]. Stem Cells, 2017, 35(1): 117-134.
[8] Atala A.Regenerative medicine strategies[J]. J Pediatr Surg, 2012, 47(1): 17-28.
[9] Schulz KF, Altman DG, Moher D, et al.CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials[J]. Ann Intern Med, 2010, 152(11): 726-732.
[10] Moher D, Hopewell S, Schulz KF, et al.CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials[J]. Int J Surg, 2012, 10(1): 28-55.
[11] US Food and Drug Administration. Consumer alert on regenerative medicine products including stem cells and exosomes[EB/OL]. (2024-12-01) [2026-06-12]. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes.
[12] Ho G, Nguyen TJ, Shahabi A, et al.A systematic review and meta-analysis of complications associated with acellular dermal matrix-assisted breast reconstruction[J]. Ann Plast Surg, 2012, 68(4): 346-56.
[13] Hasiba-Pappas SK, Tuca AC, Luze H, et al.Platelet-rich plasma in plastic surgery: a systematic review[J]. Transfus Med Hemother, 2022, 49(3): 129-142.
[14] Tan PC, Zhang PQ, Xie Y, et al.Autologous concentrated growth factors combined with topical minoxidil for the treatment of male androgenetic alopecia: a randomized controlled clinical trial[J]. Facial Plast Surg Aesthet Med, 2021, 23(4): 255-262.
[15] Chen J, Jiang H.A comprehensive review of concentrated growth factors and their novel applications in facial reconstructive and regenerative medicine[J]. Aesthetic Plast Surg, 2020, 44(3): 1047-1057.
[16] Masuki H, Okudera T, Watanebe T, et al.Growth factor and pro-inflammatory cytokine contents in platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), advanced platelet-rich fibrin (A-PRF), and concentrated growth factors (CGF)[J]. Int J Implant Dent, 2016, 2(1): 19.
[17] Rodella LF, Favero G, Boninsegna R, et al.Growth factors, CD34 positive cells, and fibrin network analysis in concentrated growth factors fraction[J]. Microsc Res Tech, 2011, 74(8): 772-777.
[18] Miron RJ, Fujioka-Kobayashi M, Bishara M, et al.Platelet-rich fibrin and soft tissue wound healing: a systematic review[J]. Tissue Eng Part B Rev, 2017, 23(1): 83-99.
[19] Alshirah AA, Elnaem MH, Al-Ani Z, et al.Effect of autologous concentrated growth factor in regenerative dentistry: a systematic review and meta-analysis[J]. JDR Clin Trans Res, 2026, 11(2): 133-148.
[20] 国家卫生健康委员会.国家卫生健康委关于印发生物医学新技术临床转化应用审批工作规范(试行)的通知:国卫科教发〔2026〕13号[EB/OL].(2026-04-30)[2026-06-12].https://www.nhc.gov.cn/qjjys/c100016/202604/6d64fdc552ee49f4abba44831d189201.shtml.
[21] 国家药品监督管理局,国家卫生健康委员会,国家中医药管理局,等.国家药监局国家卫生健康委国家中医药局国家疾控局关于发布药物临床试验质量管理规范的公告:2026年第50号[EB/OL].(2026-05-21)[2026-09-17].https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260608103856150.html.
[22] Gentile P, Sterodimas A, Pizzicannella J, et al.Systematic review: allogenic use of stromal vascular fraction (SVF) and decellularized extracellular matrices (ECM) as advanced therapy medicinal products (ATMP) in tissue regeneration[J]. Int J Mol Sci, 2020, 21(14): 4982.
[23] Park SY, Yi KH.Exosome-mediated advancements in plastic surgery: navigating therapeutic potential in skin rejuvenation and wound healing[J]. Plast Reconstr Surg Glob Open, 2024, 12(8): e6021.
[24] Théry C, Witwer KW, Aikawa E, et al.Minimal information for studies of extracellular vesicles 2018 (MISEV2018): a position statement of the International Society for Extracellular Vesicles and update of the MISEV2014 guidelines[J]. J Extracell Vesicles, 2018, 7(1): 1535750.
[25] Li M, Qu K, Lei Q, et al.Effectiveness of platelet-rich plasma in the treatment of androgenic alopecia: a meta-analysis[J]. Aesthetic Plast Surg, 2024, 48(5): 977-984.
[26] Cao S, Zhu M, Bi Y.Evaluation of the safety and efficacy of concentrated growth factors for hair growth promotion in androgenetic alopecia patients: a retrospective single-centre, single-arm study[J]. J Cosmet Dermatol, 2024, 23(12): 4051-4056.
[27] 中华人民共和国国务院.生物医学新技术临床研究和临床转化应用管理条例:中华人民共和国国务院令第818号[EB/OL].(2025-09-28)[2026-06-12].https://www.gov.cn/gongbao/2025/issue_12259/index.html.
[28] 国家卫生健康委科技教育司.做好《生物医学新技术临床研究和临床转化应用管理条例》贯彻落实,高质量满足人民群众健康需求,支撑生物医药产业更高水平发展[EB/OL].(2026-02-24)[2026-06-12].https://www.nhc.gov.cn/.