| 陆华,俞懿强,孙皎.新型高氮无镍不锈钢骨植入材料的体内外生物相容性研究[J].口腔材料器械杂志,2016,25(4):198-203. |
| 新型高氮无镍不锈钢骨植入材料的体内外生物相容性研究 |
| Study on biocompatibility testing of a novel high nitrogen nickel-free stainless steel used as bone implant materials in vitro and in vivo |
| 投稿时间：2016-06-08 修订日期：2016-08-26 |
| DOI：10.11752/j.kqcl.2016.04.07 |
| 中文关键词: 高氮无镍不锈钢 骨植入材料 生物相容性 |
| 英文关键词:High nitrogen nickel-free stainless steel Bone implant materials Biocompatibility |
| 基金项目:上海市科委项目（项目编号13441902300，15DZ2290100） |
|
| 摘要点击次数: 1319 |
| 全文下载次数: 1259 |
| 中文摘要: |
| 目的 探讨新型高氮无镍不锈钢（HNS）骨植入材料的体内外生物相容性，为其临床应用提供安全性方面的科学依据。方法 对HNS开展了细胞毒性、溶血性、遗传毒性（Ames和MLA试验）和致癌性方面的体外实验研究；进一步选择不同的动物评价了其皮内反应、致敏性和急性/亚慢性全身毒性；并以316L医用不锈钢材料为对照，研究兔胫骨内植入4w、12w和26w后HNS材料与骨组织之间的生物相容性。结果 HNS无明显的细胞毒性；无溶血；未诱发鼠伤寒沙门氏菌的体外基因回复突变；未引起体外哺乳动物细胞L5178Y/TK+/-的TK基因突变和染色体诱变；体外细胞转化试验结果为阴性；未引起动物皮肤过敏和皮内反应、不引起小鼠的急性全身毒性反应；亚慢性全身毒性试验中SD大鼠均未见临床全身毒性症状、试验组和对照组之间的体重及主要脏器体重比的差异均无统计学意义（P>0.05）、血液学和临床生化主要检测指标与对照组之间的差异均无统计学意义（P>0.05），动物的心、肺、肝、脾、肾、脑等主要脏器均未见异常改变。HNS植入后各期的组织学分析表明：相比316L医用不锈钢，HNS能更明显促进骨种植体周围的新骨形成。结论 新型HNS骨植入材料对生物体全身组织器官无潜在的危害性，生物相容性好，具有临床应用前景。 |
| 英文摘要: |
| Objective To investigate the biocompatibility of a novel high nitrogen nickel-free stainless steel (HNS) used as bone implant materials in vitro and in vivo, and to provide a scientific basis for its clinical application. Methods The cytotoxicity, hemolytic test, genetic toxicity and carcinogenesis of HNS were conducted in vitro. Meanwhile, test for irritation and skin sensitization, acute/subchronic systemic toxicity and 4w、12w and 26-week bone implantation study (with 316L stainless steel as control) were performed in the different animals to evaluate the biocompatibility of HNS material. Results Our data showed that the HNS extracts had neither cytotoxicity nor hemolysis. The HNS were considered to be nonmutagenic by the bacterial reverse mutation study and the L5178Y/TK+/- Mouse Lymphoma Mutagenesis Assay. Also the result was negative in the skin sensitization, irritation, acute/subchronic systemic toxicity test. None of the animals exhibited any signs of clinical toxicity. Organ weights and organ/body weight ratios were similar between test and control groups (P>0.05).There were no statistically significant difference in hematological and biochemical indexes between the HNS extract group and the control group (P>0.05). There was no abnormal histopathology change in the heart, liver, spleen, lung, brain and the other main organs. At 4w, 12w and 26 w after implantation, the microscopic evaluation showed that the HNS implant could significantly promote the new bone formation when compared with the 316L stainless steel. Conclusions The new HNS bone implant material has no potential harm to the whole body tissues and organs. It has good biocompatibility and prospect of clinical application. |
| 查看全文 查看/发表评论 下载PDF阅读器 |
| 关闭 |