中国医用组织库的发展历史、现状及展望

History,current situation and prospect of tissue banks in China

背景:医用组织库接收捐献的人体组织并进行相应的处理、储存与运输,以供临床各种组织缺损的修复与重建,具有重要的医学和军事意义。目的:梳理中国医用组织库的发展历史,介绍组织库在中国的发展现状,并对组织库的发展作出展望。方法:由第一作者在中国知网、万方、维普、PubMed数据库检索截至2021年10月发表的文献,中文检索词为“组织库、组织移植、组织捐献、同种异体组织、同种异体骨、同种异体皮肤、器官捐献、中国红十字会、规范、标准”,英文检索词为“Tissue Bank,Tissue Transplantation,Tissue Donation,Allograft,Bone Allograft,Skin Allograft,Vascular Allograft,Organ Donation,Red Cross Society of China,Regulation,Standard”。辅以国家药品监督管理局官方网站信息查询,以及查阅《同种组织移植和组织库》专业书籍资料,与组织库从业人员交流访谈,实地考察,形成最终文稿。结果与结论:①中国医用组织库起步于20世纪50年代,期间历经了小规模医院内组织库、民办非营利专业组织库、规模化企业组织库等发展阶段。②到了20世纪90年代,企业性质组织库纷纷成立,同种异体组织修复材料的研发及应用也逐步完善,包括同种异体骨、皮肤、肌腱、神经等多种材料分别获得第三类医疗器械注册证。③进入21世纪后,民办非企业性质组织库兴起,这时中国医用组织库主要有院内组织库、企业组织库和民办非企业性质组织库为主的3大类型组成,并且随着中国器官和组织捐献工作的有效开展,组织材料临床使用量也逐年攀升,同种异体组织修复材料已成为临床上不可或缺的组织修复与重建生物材料。④在2020年,随着《人体器官移植条例(修订草案)(征求意见稿)》向社会征集意见,《中华人民共和国民法典》的颁布实施,组织库的发展迎来了机遇也伴随着挑战,未来相信在科技和人文持续发展下,中国的医用组织库事业将迎来较大的发展。

BACKGROUND:Tissue bank receives donated human tissues and organs and performs various corresponding processing,including storage and transportation for the purposes to repair and to reconstruct various clinical tissue defects.OBJECTIVE:To predict the development of tissue banks in China by sorting out the development history of medical tissue banks and introducing the development status of tissue banks.METHODS:The first author searched the literature data published up to October 2021 through databases such as CNKI,WanFang,VIP,and PubMed.The search terms were“tissue bank,tissue transplantation,tissue donation,allograft,bone allograft,skin allograft,vascular allograft,organ donation,Red Cross Society of China,regulation,standard”in Chinese and English.The final manuscript was complete based on information inquiry on the official website of the National Medical Drugs Administration of China,as well as access to a professional book,Allogeneic Tissue Transplantation and Tissue Bank,exchange interviews with tissue bank practitioners,and on-the-spot investigations.RESULTS AND CONCLUSION:Medical tissue banks in China started in the 1950s,and have gone through the development stages of small-scale hospital tissue bank,non-profit tissue bank,and large-scale enterprise tissue bank.In the 1990s,tissue banks with enterprise nature were established in succession,the development and application of allogeneic tissues as materials for tissue repair were gradually improved.Various materials including allogeneic bone,skin,tendon,nerve and other materials have obtained the third-class medical device registration certificate.After entering the 21s t century,non-profit tissue banks have emerged.At this time,tissue banks are mainly composed of three types:hospital tissue banks,enterprise nature tissue banks and non-profit tissue banks.With the effective development of the work,the clinical use of tissue materials has also increased yearly,and allogeneic tissue repair materials have become indispensable biomaterials for tissue repair and reconstruction in clinical practice.In 2020,with the“Regulations on Human Organ Transplantation(Draft Amendment)”soliciting opinions from the public and the promulgation and implementation of the“Civil Code of the People’s Republic of China,”the development of tissue banks has ushered in opportunities and challenges.It is believed that under the continuous development of science and technology and humanities,medical tissue banks will have greater development.