α-Gal抗原与动物源性医疗器械免疫原性风险控制

背景：目前动物源性医疗器械被广泛应用于临床，尽管它的有效性得到了认可，但它的安全性特别是免疫原性日益受到人们的关注。目的：为了保证动物源性医疗器械的质量安全，研究其免疫原性风险控制。方法：作者应用计算机检索 Sciencedirect 数据库、Wiley-Blackewel 电子期刊数据库和万方数据库中1985年1月至2013年6月的文章，在标题和中以“α-Gal抗原，免疫原性，异种移植”或“α-Gal antigen, immunity, xenotransplantation”为检索词进行检索。结果与结论：目前对异种植入物抗原中Galα1-3Gal抗原（即α-Gal抗原）的研究较多。α-Gal抗原存在于大量非灵长类哺乳动物、新世纪猴体内糖基化合物中，在人类及旧世纪猴体内不表达，但在人体中存在抗α-Gal抗体。α-Gal抗原与抗α-Gal抗体的结合形成了异种移植的免疫屏障。为了保证动物源性医疗器械的使用安全有效，应对动物源性材料进行选择，采用适当的工艺减少或去除α-Gal 抗原，同时还应建立灵敏度高、重复性好的α-Gal抗原检测方法。

Alpha-Gal antigen and immunity risk control of animal-derived medical devices

BACKGROUND：Medical devices from animals are commonly used in clinical application. Despite their efficiency is widely accepted, their safety, especialy immunity has been concerned. OBJECTIVE：To investigate immunity risk control to medical devices from animals for safety consideration. METHODS：Using “α-Gal antigen, immunity, xenotransplantation” in Chinese and English as the key words, the first author conducted a computer search of Science direct database （www.sciencedirect.com）, Wiley-Blackewel database （http：//onlinelibrary.wiley.com） and Wanfang database （www.wanfang.com.cn） through screening the titles and abstracts. RESULTS AND CONCLUSION：Increasing evidence shows that, Gal α1-3Gal antigen （α-Gal antigen） is recognized as the major antigen and abundantly expressed on glycoconjugates of non-primate mammals and New World monkeys. In contrast, the α-gal epitope is not expressed on glycoconjugates of humans and Old World monkeys. Instead, they produce a very large amount of natural anti-α-Gal antibody that specificaly binds the α-galepitope. The binding of human natural anti-α-Gal to α-gal epitopes expressed on non-primate mammal animals was expected to be unique immunological barrier in xenotransplantation. Therefore, it is important to choose raw materials, reduce or eliminate the α-Ggal epitope, establish highα-Ggal epitope detection methods with high sensitivity and good repeatability for achieving a greater safety and efficiency of medical devices from animals.