摘要
目的应用动物实验方法对聚酯聚乙烯复合膜/聚乙烯(冠状动脉支架)进行血液、遗传毒性和肌肉的生物相容性评价。方法依据ISO10993-10方法通过对家兔血液相容性试验、遗传毒性试验和肌肉植入后局部反应试验进行生物相容性评价。结果凝血酶时间(TT)、凝血酶原时间(PT)、部分凝血活酶时间(APTT)在使用支架前后无明显差异,血浆纤维蛋白原(Fg)水平在术后1～4h逐渐下降,至24h恢复正常;血小板计数从1h开始下降,至24h后逐步恢复正常。局部肌肉临床解剖和组织学观察未见异常、未见染色体发生畸变。包装材料无泄漏情况、包装材料与细菌培养基接触部位未见细菌生长。结论聚酯聚乙烯复合膜/聚乙烯(冠状动脉支架)对兔的凝血功能没有影响,由于创伤24h内对血栓形成有一定的影响,24h后对血栓形成无影响;无遗传毒性、无局部肌肉刺激反应;包装材料无泄漏、可以阻菌,延长了支架的货架期。
Objective To evaluate the biocompatibility which include blood, muscle and genotoxicity of coronary stents in rabbits. Methods Based on ISO10993-10,the assessments ofbiocompatibility were identified by experiment of the blood compatibility, genetic toxicity test and local reactions of muscle embedding test. Results 1.Coronary stents had no effects on the coagulation system of the rabbits 2. The histopathology and clinical anatomical observation of the local muscle were normal and no chromosome aberration. 3.The package remained sterile and no leakage were found. Conclusion 1. In rabbits coronary stents had no effects on the coagulation system, no local irritative reaction and genotoxicity as well. 2.The package remained no leakage and the efficacy of the package in blockage of bacteria appeared to be very effective.
出处
《实验动物与比较医学》
CAS
2007年第2期119-122,共4页
Laboratory Animal and Comparative Medicine
关键词
生物相容性
血液相容性
遗传毒性
染色体畸变
Blood-compatibility
Genotoxicity
Biocompatibility Chromosomal aberration
