CAJ | 학술논문

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。
배경：목전동물원성의료기계피엄범응용우림상，진관타적유효성득도료인가，단타적안전성특별시면역원성일익수도인문적관주。목적：위료보증동물원성의료기계적질량안전，연구기면역원성풍험공제。방법：작자응용계산궤검색 Sciencedirect 수거고、Wiley-Blackewel 전자기간수거고화만방수거고중1985년1월지2013년6월적문장，재표제화중이“α-Gal항원，면역원성，이충이식”혹“α-Gal antigen, immunity, xenotransplantation”위검색사진행검색。결과여결론：목전대이충식입물항원중Galα1-3Gal항원(즉α-Gal항원)적연구교다。α-Gal항원존재우대량비령장류포유동물、신세기후체내당기화합물중，재인류급구세기후체내불표체，단재인체중존재항α-Gal항체。α-Gal항원여항α-Gal항체적결합형성료이충이식적면역병장。위료보증동물원성의료기계적사용안전유효，응대동물원성재료진행선택，채용괄당적공예감소혹거제α-Gal 항원，동시환응건립령민도고、중복성호적α-Gal항원검측방법。
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-gal epitope. 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.