CAJ | 학술논문

背景:微弧氧化工艺是一种直接在金属表面原位生长陶瓷层的新型表面处理技术.而作为种植体材料的表面改性技术还处于实验阶段,有关其生物相容性的研究报道较少.目的:采用微弧氧化工艺对钛片进行表面改性,并检测这种改性后生物材料的溶血率.设计:设置阳性、阴性对照,对比观察,金标准对照.单位:武汉协和医院.材料:选用健康雄性成年新西兰大白兔1只,普通级,体质量2.5 kg.纯钛棒TA1(宝鸡市英耐特有色金属有限公司);经过微弧氧化表面改性处理的钛试件;20 g/L草酸钾.方法:实验于2006-05在华中科技大学同济医学院附属协和医院普外科实验市完成.①材料:按一定比例配置去离子水和磷酸氢二钠、乙酸钙成微弧氧化电解液,直径为10 mm,厚度为2 mm的钛片置于电解液中表面进行微弧氧化反应10 min.②实验分组:实验组、阴性对照组及阳性对照组.实验组:微弧氧化-Ti试件,浸泡在10 mL生理盐水的试管中;阳性对照组:每个试管加10 mL去离子水;阴性对照组:每个试管加10 mL生理盐水.③实验操作:抽取新西兰大白兔新鲜全血,抗凝后分别与实验组和阳性对照、阴性对照组接触,用紫外-可见光分光光度计比色,评价各组的溶血率.按国际化标准组织规定要求,以溶血率≤5%判定材料符合医用材料的溶血要求,溶血率＞5%预示材料有溶血作用.主要观察指标:3组材料的溶血率.结果:实验组溶血率为0.90%,提示该种植材料无溶血作用.结论:微弧氧化钛基材料对红细胞无毒性作用,符合国内外溶血测试标准.
배경:미호양화공예시일충직접재금속표면원위생장도자층적신형표면처리기술.이작위충식체재료적표면개성기술환처우실험계단,유관기생물상용성적연구보도교소.목적:채용미호양화공예대태편진행표면개성,병검측저충개성후생물재료적용혈솔.설계:설치양성、음성대조,대비관찰,금표준대조.단위:무한협화의원.재료:선용건강웅성성년신서란대백토1지,보통급,체질량2.5 kg.순태봉TA1(보계시영내특유색금속유한공사);경과미호양화표면개성처리적태시건;20 g/L초산갑.방법:실험우2006-05재화중과기대학동제의학원부속협화의원보외과실험시완성.①재료:안일정비례배치거리자수화린산경이납、을산개성미호양화전해액,직경위10 mm,후도위2 mm적태편치우전해액중표면진행미호양화반응10 min.②실험분조:실험조、음성대조조급양성대조조.실험조:미호양화-Ti시건,침포재10 mL생리염수적시관중;양성대조조:매개시관가10 mL거리자수;음성대조조:매개시관가10 mL생리염수.③실험조작:추취신서란대백토신선전혈,항응후분별여실험조화양성대조、음성대조조접촉,용자외-가견광분광광도계비색,평개각조적용혈솔.안국제화표준조직규정요구,이용혈솔≤5%판정재료부합의용재료적용혈요구,용혈솔＞5%예시재료유용혈작용.주요관찰지표:3조재료적용혈솔.결과:실험조용혈솔위0.90%,제시해충식재료무용혈작용.결론:미호양화태기재료대홍세포무독성작용,부합국내외용혈측시표준.
BACKGROUND: Microarc oxidation (MAO) is a break-through anodyzing technology for forming oxide films on valve metal.Use of this technology allows thick, porous oxide layers to be formed on the surface of pure titanium. Few biocompatibility reports using this treatment have been found.OBJECTIVE: The blood compatibility of a novel surface modified titanium substrata biomaterial using MAO was investigated.DESIGN: Positive and negative control, contrast observation and gold standard control.SETTING: Wuhan Union Hospital.MATERIALS: A healthy male adult New-Zealand rabbit, weighing 2.5 kg and ordinary grade, was selected in this study.Pure titanium sticks TA1 (Baoji Yingnaite Non-ferrous Metal Co., Ltd.), MAO-Ti and 20 g/L potassium oxalate were also selected in this study.METHODS: The study was carried out in the Laboratory of General Surgery, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology in May 2006. ① Materials: Titanium substrate of 10 mm in diameter and 2 mm in depth was put in an electrolyte which was quipped with deionized water, dibasic sodium phosphate, and ethanoic acid calcium for MAO treatment for 10 minutes. ② Groups: Three groups were analysed: test group, negative control group and positive control group. Test group: MAO-Ti was dipped in 10 mL saline; Positive control group: 10 mL deionized water was added in each tube; Negative control group: 10 mL saline was added in each tube. ③ Operation: Fresh whole blood was collected from rabbit and then mixed with the liquids in the three groups respectively after anti-coagulation. In addition, UV-Visible Spectrophotometer was used to evaluate the hemolytic ratio. A hemolytic ratio below or equal to 5% indicated that this novel material fitted the requirements. On the contrary, a hemolytic ratio higher than 5% proofed the existence of a hemolyzation.MAIN OUTCOME MEASURES: The hemolytic ratio of materials in three groups.RESULTS: The hemolytic ratio of the test group was 0.90%. The result indicated that this new material had no haemolysis effect.CONCLUSION: The material does not resolve red blood cells and is coincident with the international and governmental standard.