皮肤替代物及其有效性评价的研究进展
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摘要
皮肤替代物发展迅速,在临床使用前对皮肤替代物进行合理的有效性评价非常必要。该文对皮肤替代物的发展概况、皮肤替代物临床前有效性评价方法及相关标准进行了简要的综述和讨论。文章重点介绍了皮肤替代物临床前有效性评价的体外及体内方法,为合理对其临床前安全性评价提供了理论依据。
Skin-substitute has developed rapidly and it is essential to evaluate its effectiveness before clinical use. This paper reviews the development of skin-substitute, methods to evaluate the effectiveness of skin-substitute and relevant standards. This paper highlights the in vitro and in vivo means of preclinical effectiveness evaluation and provides theoretical basis for preclinical safety evaluation of skin-substitute.
Skin-substitute has developed rapidly and it is essential to evaluate its effectiveness before clinical use. This paper reviews the development of skin-substitute, methods to evaluate the effectiveness of skin-substitute and relevant standards. This paper highlights the in vitro and in vivo means of preclinical effectiveness evaluation and provides theoretical basis for preclinical safety evaluation of skin-substitute.
引文
[1]贾赤宇.进一步理性看待皮肤替代物[J].中华损伤与修复杂志(电子版),2013,8(2):4-6.
[2]SANJAIRAJ V.3D bioprinting of skin:A state-of-the-art review on modelling,materials,and processes[J].Biofabrication,2016,8(3):032001.
[3]HODGKINSON T,BAYAT A.Dermal substitute-assisted healing:enhancing stem cell therapy with novel biomaterial design[J].Arch Dermatol Res,2011,303(5):301-315.
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[7]ROY M,KING T W.Epidermal growth factor regulates NIKSkeratinocyte proliferation through Notch signaling[J].J Surg Res,2013,185(1):6-11.
[8]CENTANNI J M,STRASESKI J A,WICKS A,et al.StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds:results from a prospective,randomized,controlled dose escalation trial[J].Ann Surg,2011,253(4):672-683.
[9]SCHURR M J,FOSTER K N,CENTANNI J M,et al.Phase I/II clinical evaluation of StrataGraft:a consistent,pathogen-free human skin substitute.[J].J Neurotraum,2009,66(3):866-73;discussion 873-874.
[10]UD-DIN S,BAYAT A.Non-animal models of wound healing in cutaneous repair:In silico,in vitro,ex vivo,and in vivo models of wounds and scars in human skin[J].Wound Repair Regen,2017,25(2):164-176.
[11]PATEL S,MAHESHWARI A,CHANDRA A.Biomarkers for wound healing and their evaluation[J].J Wound Care,2016,25(1):46.
[12]SHAH J M,OMAR E,PAI D R,et al.Cellular events and biomarkers of wound healing[J].Indian J Plast Surg,2012,45(2):220-228.
[13]AZIZ G,ABDI G.Role of keratinocyte-fibroblast cross-talk in development of hypertrophic scar[J].Wound Repair Regen,2007,15(s1):S46-S53.
[14]WONG V W,SORKIN M,GLOTZBACH J P,et al.Surgical Approaches to Create Murine Models of Human Wound Healing[J].Biomed Res Int,2011,2011(1110-7243):969618.
[15]REBECCA R,KRASIMIR S,CHRISTOPHER K,et al.Adult zebrafish as a model system for cutaneous wound healing research[J].J Invest Dermatol,2013,133(6):1655.
[16]尚玉茹,申传安,海恒林,等.大鼠全层皮肤缺损创面抗挛缩模型的建立[J].中华损伤与修复杂志(电子版),2012(6):596-599.
[17]何秀叶,宋慧锋,郭希民.组织工程皮肤创面修复动物模型的研究进展[J].解放军医学杂志,2017(3):239-242.
[18]高富雷,王丹茹,张余光.创伤愈合动物模型的研究进展[J].中国美容医学,2007(2):278-281.
[19]FALANGA V,SCHRAYER D,CHA J,et al.Full-thickness wounding of the mouse tail as a model for delayed wound healing:accelerated wound closure in Smad3 knock-out mice[J].Wound Repair Regen,2004,12(3):320-326.
[20]HOLLANDER D A,ERLI H J,THEISEN A,et al.Standardized qualitative evaluation of scar tissue properties in an animal wound healing model.[J].Wound Repair Regen,2003,11(2):150-157.
[21]HASATSRI S,ARAMWIT P.Nontraditional methods to evaluate wound healing[J].Dermatol Sur,2017,43(3):342.
[2]SANJAIRAJ V.3D bioprinting of skin:A state-of-the-art review on modelling,materials,and processes[J].Biofabrication,2016,8(3):032001.
[3]HODGKINSON T,BAYAT A.Dermal substitute-assisted healing:enhancing stem cell therapy with novel biomaterial design[J].Arch Dermatol Res,2011,303(5):301-315.
[4]KIM S S,SONG C K,SHON S K,et al.Effects of human amniotic membrane grafts combined with marrow mesenchymal stem cells on healing of full-thickness skin defects in rabbits.[J].Cell Tissue Res,2009,336(1):59-66.
[5]LEE L F,JIANG T X,GARNER W,et al.A simplified procedure to reconstitute hair-producing skin.[J].Tissue Engeering Part CMethods,2011,17(4):391.
[6]KIM B S,LEE J S,GAO G,et al.Direct 3D cell-printing of human skin with functional transwell system[J].Biofabrication,2017,9(2):025034.
[7]ROY M,KING T W.Epidermal growth factor regulates NIKSkeratinocyte proliferation through Notch signaling[J].J Surg Res,2013,185(1):6-11.
[8]CENTANNI J M,STRASESKI J A,WICKS A,et al.StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds:results from a prospective,randomized,controlled dose escalation trial[J].Ann Surg,2011,253(4):672-683.
[9]SCHURR M J,FOSTER K N,CENTANNI J M,et al.Phase I/II clinical evaluation of StrataGraft:a consistent,pathogen-free human skin substitute.[J].J Neurotraum,2009,66(3):866-73;discussion 873-874.
[10]UD-DIN S,BAYAT A.Non-animal models of wound healing in cutaneous repair:In silico,in vitro,ex vivo,and in vivo models of wounds and scars in human skin[J].Wound Repair Regen,2017,25(2):164-176.
[11]PATEL S,MAHESHWARI A,CHANDRA A.Biomarkers for wound healing and their evaluation[J].J Wound Care,2016,25(1):46.
[12]SHAH J M,OMAR E,PAI D R,et al.Cellular events and biomarkers of wound healing[J].Indian J Plast Surg,2012,45(2):220-228.
[13]AZIZ G,ABDI G.Role of keratinocyte-fibroblast cross-talk in development of hypertrophic scar[J].Wound Repair Regen,2007,15(s1):S46-S53.
[14]WONG V W,SORKIN M,GLOTZBACH J P,et al.Surgical Approaches to Create Murine Models of Human Wound Healing[J].Biomed Res Int,2011,2011(1110-7243):969618.
[15]REBECCA R,KRASIMIR S,CHRISTOPHER K,et al.Adult zebrafish as a model system for cutaneous wound healing research[J].J Invest Dermatol,2013,133(6):1655.
[16]尚玉茹,申传安,海恒林,等.大鼠全层皮肤缺损创面抗挛缩模型的建立[J].中华损伤与修复杂志(电子版),2012(6):596-599.
[17]何秀叶,宋慧锋,郭希民.组织工程皮肤创面修复动物模型的研究进展[J].解放军医学杂志,2017(3):239-242.
[18]高富雷,王丹茹,张余光.创伤愈合动物模型的研究进展[J].中国美容医学,2007(2):278-281.
[19]FALANGA V,SCHRAYER D,CHA J,et al.Full-thickness wounding of the mouse tail as a model for delayed wound healing:accelerated wound closure in Smad3 knock-out mice[J].Wound Repair Regen,2004,12(3):320-326.
[20]HOLLANDER D A,ERLI H J,THEISEN A,et al.Standardized qualitative evaluation of scar tissue properties in an animal wound healing model.[J].Wound Repair Regen,2003,11(2):150-157.
[21]HASATSRI S,ARAMWIT P.Nontraditional methods to evaluate wound healing[J].Dermatol Sur,2017,43(3):342.