CAJ | 학술논문

目的：考察一种新型的生物人工血管的生物相容性。方法：依据G B/T16886医疗器械生物学评价标准规定的细胞毒性、急性毒性试验、皮内刺激试验、致敏试验、溶血试验、亚慢性毒性试验、植入试验和遗传毒性试验方法评价生物人工血管的生物相容性，以验证其安全性和有效性。结果：显示生物人工血管无急性毒性、无皮内刺激作用、无致敏作用，溶血率不大于5%；细胞毒性为0级；皮下植入后1周、4周、12周和26周样品的炎症反应和纤维囊形成与对照无明显差别；遗传毒性采用鼠伤寒沙门氏菌回复突变试验(Ames试验)、体外哺乳动物细胞染色体畸变试验、哺乳动物细胞体外基因突变试验均为阴性，说明生物人工血管无遗传毒性。结论：生物人工血管具有良好的生物相容性，没有观察到不良反应，符合临床使用要求。
목적：고찰일충신형적생물인공혈관적생물상용성。방법：의거G B/T16886의료기계생물학평개표준규정적세포독성、급성독성시험、피내자격시험、치민시험、용혈시험、아만성독성시험、식입시험화유전독성시험방법평개생물인공혈관적생물상용성，이험증기안전성화유효성。결과：현시생물인공혈관무급성독성、무피내자격작용、무치민작용，용혈솔불대우5%；세포독성위0급；피하식입후1주、4주、12주화26주양품적염증반응화섬유낭형성여대조무명현차별；유전독성채용서상한사문씨균회복돌변시험(Ames시험)、체외포유동물세포염색체기변시험、포유동물세포체외기인돌변시험균위음성，설명생물인공혈관무유전독성。결론：생물인공혈관구유량호적생물상용성，몰유관찰도불량반응，부합림상사용요구。
purpose:The research reviewed biocompatibility of biological artiifcial vascular which is a new vascular substitution. Method:We studied the biological artiifcial vascular biocompatibility using the cytotoxicity,acute toxicity, subcutaneous reactivity, sensitization, hemolytic test, subchronic toxicity, subcutaneous implantation and genotoxicity tests described in GB/T16886. The experimental results showed that the biological artiifcial vascular has no acute reaction, no subchronic reactivity, no sensitization, hemolysis ratio not exceeding 5%, cytotoxicity is 0 grade, no obvious inlfammatory reaction and ifbrous capsule difference between sample and control after 1, 4, 12and 26 weeks implantation. The negative results of Ames test and mammalian cellchromosome aberration as wel mammalian cellgene mutation test demonstrated the biological artiifcial vascular has no genotoxicity. Result:The biological artiifcial vascular has excellent biocompatibility and meet the requirement for clinical application.