A Review of Skin Banking Guidelines and Standards Worldwide:Towards the Harmonization of Guidelines for Skin Banking in Therapeutic Applications for the Regions under the Asia Pacific Burn Association(APBA)

Currently,there are no harmonized guidelines which govern skin banking in the Asia Pacific region.Therefore,skin banks are either unregulated or rely on their nation’s legislation or international accreditation to uphold their quality standards.A new set of skin banking guidelines was devel-oped through a comprehensive review and collation of best international practices for the Asia Pacific Burn Association(APBA)members,from donor screening and testing,to skin recovery,processing,storage and distribution,and quality assurance.National regulatory requirements reviewed include the European directives,Australia’s Therapeutic Goods Administration and Sin-gapore’s tissue banking standards.Further technical and quality management recommendations are referenced from the American Association of Tissue Banks(AATB),the United States Food and Drug Administration standards and guidance documents,various relevant European guides,Japanese Society of Tissue Transplantation guidelines and the Asia Pacific Association of Surgical Tissue Banking.Adapted mainly from the AATB standards,the new Asia Pacific Burn Association Guidelines for Skin Banking in Therapeutic Applications offer a comprehensive manual,address-ing:governance and contracts;staff responsibilities;quality management;facilities,equipment and supplies management;donor consent and testing;and recommendations of good practices pertaining to skin recovery,processing,storage and distribution.Besides complementing current generic regulations,they provide technical specifications of major aspects unaddressed in most legislations.This inaugural set of new regional skin banking guidelines would be a start for regional members of the APBA to adopt,and will hopefully culminate in a set of standards so that,in the long run,skin allografts from this region can be of similar quality,which can simplify import process and facilitate the exchange of allografts between members.

First-year experience of a new skin bank in Brazil

Aim:To report the 1st year experience of the skin bank opened at the Evangelical University Hospital of Curitiba(HUEC),Brazil in June 2013.Methods:A retrospective statistical and epidemiological study was conducted from data obtained from the activities of the HUEC skin bank from June 2013 to August 2014.Results:The HUEC skin bank harvested tissue from 45 cadaveric donors(46.6%female and 53.3%male),with an average age of 36.42.The white skin-colored donors represented 91%of donations.Most causes of death were of neurological origin(55.6%).Eighty-one batches were harvested.The bank processed 31,314.63 cm^(2)of skin for transplantation(41 batches),and 38 batches were discarded.The distributed allografts totaled 28,940.82 cm^(2),with tissue from a single donor benefitting up to 5 patients.A total of 52 transplant procedures were performed(66.6%of recipients were male and 33.3%female),burn victims represented 83.3%of the recipients.Conclusion:The HUEC skin bank provides skin primarily for victims with severe third-degree burns,mostly men,and who are treated and transplanted in the HUEC as a result of high demand.The successful outcomes highlight the potential use for other clinical indications.

中国医用组织库的发展历史、现状及展望

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。

战备烧伤异体皮的获取及皮库建设的探讨

现代战争导致烧伤的发生率明显增高,大批量大面积深度烧伤伤员将集中在短时间内出现。同种异体皮移植是目前抢救大面积烧伤的主要手段之一,但来源极其匮乏。故重点讨论了烧伤同种异体皮的来源及建立战备皮库的必要性、存在的问题和主要的解决方法。

计算机图像分析系统评价斑克治疗黄褐斑疗效

目的:研究探索计算图像分析系统评价斑克治疗黄褐斑的临床疗效和方法。方法:应用计算机皮肤数字图像分析系统,采用平均光密度、面积二项指标,评价斑克治疗黄褐斑的临床效果。结果:通过计算机数字图像分析系统分析表明,经斑克治疗后5周较治疗前的平均光密度明显下降和皮损面积明显缩小,经统计学处理有显著性差异(P<0.05)。结论:计算机图象分析系统的疗效评价更具有客观性,斑克治疗黄褐斑的临床效果好。

两种阴茎消毒方式对捐精者取精过程及精液参数的影响

目的:比较碘复合物消毒液和季铵盐类消毒湿巾两种消毒方式对捐精志愿者取精过程及精液质量影响,为辅助生殖技术过程中需无菌采集精液选取较为理想的消毒方法提供参考依据。方法:研究对象采用未消毒(对照组)和两种消毒方式各采集1份精液样本,阴茎消毒2015年8~12月采用碘复合物消毒液(碘剂组,n=63),2016年1~7月采用湿巾消毒(湿巾组,n=122)。精液采集完成后填写《阴茎消毒对采集精液过程影响调查问卷》。结果:碘剂组1例疑似消毒液污染,其余全部完成试验。消毒对采精过程影响方面,两组志愿者对消毒后是否存在不适感及后期对消毒操作程序认真态度2个选项之间有统计学差异(P均<0.05),其他选项无显著差异(P均>0.05)。精液质量方面,碘剂组与其对照组比较,前向运动精子百分率[(63.02±3.18)%vs(61.45±4.78)%]存在显著差异(P<0.05),而禁欲时间[(4.97±1.79)d vs(4.7±0.94)d]、精液体积[(4.11±1.54)ml vs(4.15±1.61)ml]、精子浓度[(110±29.6)×106/ml vs(107.5±31.79)×106/ml]、精子总数[(439.10±170.13)×106vs(434.02±186.91)×106]均无显著差异(P均>0.05);湿巾组与其对照组比较,禁欲时间、精液体积、精子浓度、前向运动精子百分率、精子总数均无显著差异(P>0.05)。另外,获得的精液异常质量样本中,碘剂组中精液前向运动精子百分率异常比例[9.68%(6/62)]与湿巾组[1.64%(2/122)]相比,差异有显著性(P<0.05),而精液体积异常比例、精子浓度异常比例、精液细菌污染率在两种消毒方式间均无显著性差异(P均>0.05)。结论:碘伏消毒剂对捐精者取精过程和精液质量有一定影响,而湿巾消毒方式可以减少对捐精者取精过程影响,不影响精液参数。

基于离心试验的斜顶桩接岸结构负摩阻力研究

上海洋山港高桩码头后方接岸结构采用斜顶桩接岸结构,目前对该结构中斜顶桩、板桩的负摩阻力鲜有研究,且缺乏对负摩阻力主要产生原因的认识。为对接岸结构中各桩负摩阻力特性有较全面的认识,通过简化边界条件建立概化物理模型,利用土工离心试验来实测接岸结构在特定条件下的变形和受力情况。根据相关资料和试验数据,着重分析了结构和土体变形,进而分析各桩轴向力和负摩阻力沿桩深分布规律,并对负摩阻力产生的主要原因进行阐述,最后采用原型观测验证物模结果。试验研究结果表明:接岸结构各桩均在桩身一定范围内产生负摩阻力,其中性点位置与桩长比例范围约为0.63~0.75;且软黏土固结是斜顶桩接岸结构中桩基负摩阻力产生的主要原因。

人皮肤成纤维细胞库的构建

目的建立成纤维细胞系及细胞库。方法采用体外细胞培养技术进行皮肤成纤维细胞的分离、培养、传代、冻存、复苏及鉴定。结果人皮肤成纤维细胞传代至23代以上,此时的细胞数是原代培养的细胞数的数十万倍,经冻存、复苏后,人皮肤成纤维细胞仍具有增殖能力,生长状态与原代培养的人皮肤成纤维细胞相类似。结论酶消化法是培养人皮肤成纤维细胞简便、快捷的方法。

软土固结的负摩阻力对斜顶桩接岸结构影响

上海洋山港高桩码头后方挡土结构采用斜顶桩接岸结构,目前软土固结对该结构的负摩阻力影响研究仍较缺乏。为对我国今后深水建港积累经验,采用有限元仿真技术,以洋山港一期工程斜顶桩接岸结构作为原型,分析施工期抛填成陆后各桩负摩阻力随软土固结发展的规律,并以原型观测数据验证了数模结果。研究结果表明:软土固结导致桩周土体发生相对桩基的竖向位移,在各桩表面产生负摩阻力,且软土固结主要发生于主固结阶段。在该阶段内,负摩阻力的发展具有时间效应,会在桩基表面形成下拉荷载,其对板桩、支撑桩的影响更大,建议采取多种措施削弱负摩阻力的不利影响。