中国组织工程研究

中国组织工程研究 ›› 2010, Vol. 14 ›› Issue (38): 7145-7148.doi: 10.3969/j.issn.1673-8225.2010.38.028

• 生物材料综述 biomaterial review • 上一篇    下一篇

细胞外基质材料的安全性能

沈曼茹，袁建明，张永珍，熊绍虎，党瑞山，张传森   

  1. 解放军第二军医大学人体解剖学教研室，上海市  200433
  • 出版日期:2010-09-17 发布日期:2010-09-17
  • 通讯作者: 张传森，教授，解放军第二军医大学人体解剖学教研室，上海市 200433 chuansen@yahoo.com
  • 作者简介:沈曼茹★，女，1968年生，上海市人，解放军第二军医大学在读硕士，主要从事组织工程产品安全性评价的研究。 Smrself@126.com

Safety of extracellular matrix materials

Shen Man-ru, Yuan Jian-ming, Zhang Yong-zhen, Xiong Shao-hu, Dang Rui-shan, Zhang Chuan-sen   

  1. Department of Human Anatomy, Second Military Medical University of Chinese PLA, Shanghai   200433, China
  • Online:2010-09-17 Published:2010-09-17
  • Contact: Zhang Chuan-sen, Professor, Department of Human Anatomy, Second Military Medical University of Chinese PLA, Shanghai 200433, China chuansen@yahoo.com
  • About author:Shen Man-ru★, Studying for master’s degree, Department of Human Anatomy, Second Military Medical University of Chinese PLA, Shanghai 200433, China Smrself@126.com

PDF

336

被引次数

7

摘要：

背景：组织工程医疗产品最终要植入体内，植入产品的生物相容性决定其能否长期在体内发挥正常的功能。因此安全性评价是决定组织工程医疗产品最终能否应用于临床的重要环节。
目的：从细胞的毒性试验、与血液的相互作用实验、植入后局部反应试验、免疫学评价等方面，介绍对细胞外基质材料进行安全性评价的方法。
方法：以“组织工程(tissue-engineering)，细胞外基质(Extracellular Matrix)，生物相容性(Biocompatibility)，安全性评价(afety Evaluation)”为检索词，应用计算机检索维普数据库，Pubmed数据库，Elsevier数据库有关文章。纳入与细胞外基质材料安全性评价方法密切相关的文献，排除重复性研究。
结果与结论：共检索到218篇文献，排除无关重复的文献，保留22篇文献进行综述。目前对于细胞外基质材料还没有整体的安全性评价方法，对于生物材料成分的结构和功能特性及生物相容性进行评价主要依据ISO 10993系列医疗器械生物学评价方法。随着细胞外基质材料的广泛应用，对细胞外基质的安全性评价会越来越受到重视，许多问题还有待探讨。

关键词: 细胞外基质, 生物相容性, 安全性, 评价方法, 生物材料

Abstract:

BACKGROUND: Tissue engineered medical products are eventually implanted into body, the biocompatibility of implanted products determines their long-term function in body. Therefore, safety evaluation is critical to determine whether tissue engineered medical products are used in clinical practice.
OBJECTIVE: To introduce the methods of safety evaluation of extracellular matrix materials from cell toxicity, interaction with blood test, local reactions after implantation, immunological evaluation.
METHODS: Using “tissue engineering, extracellular matrix, biocompatibility, safety evaluation” in Chinese and English as key words, a computer search was performed in VIP database, Pubmed database, Elsevier database for relevant articles. Articles related with safety assessment of extracellular matrix materials were included, repeated researches were excluded.
RESULTS AND CONCLUSION: A total of 218 articles were screened out, unrelated duplicated literatures were eliminated, remaining 22 articles were reviewed. Currently there is no overall safety evaluation method of the extracellular matrix material, the structural and functional properties of biological materials as well as biocompatibility are assessed according to ISO 10993 series of biological evaluation of medical devices. With extracellular matrix materials have been widely used, more and more attention have been paid on the safety evaluation of extracellular matrix, many questions still to be explored.

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