全内置式可膨胀型生物涂层脊柱前路内固定系统最大剂量的致敏实验  

A unique built-in expandable bio-coating anterior spinal fixation: a sensitization test at the maximum sensitization dosage

作　　者：黄学良 朱双芳 林雨聪 周初松[1] Huang Xue-liang;Zhu Shuang-fang;Lin Yu-cong;Zhou Chu-song(Zhujiang Hospital,Southern Medical University,Guangzhou 510282,Guangdong Province,China)

机构地区：[1]南方医科大学珠江医院,广东省广州市510282

出　　处：《中国组织工程研究》2018年第30期4769-4773,共5页Chinese Journal of Tissue Engineering Research

基　　金：广东省科技计划项目(2013B091500073);名称:全内置式可膨胀型生物涂层脊柱前路内固定系统的研发;广州市科技计划项目(2014J4100131);名称:全内置式可膨胀型生物涂层脊柱前路内固定系统的研发~~

摘　　要：背景:前期实验证明全内置式可膨胀型生物涂层脊柱前路内固定系统具有良好的生物力学性能,可重建损伤胸腰椎的稳定性。目的:进一步评价全内置式可膨胀型生物涂层脊柱前路内固定系统的致敏性。方法:取全内置式可膨胀型生物涂层脊柱前路内固定系统浸提液(实验组)、生理盐水(阴性对照组)、体积分数5%甲醛溶液(阳性对照组),按《GB/T 16886.10-2005医疗器械生物学评价第10部分刺激与迟发型超敏反应试验》规定的最大剂量致敏实验方法,进行豚鼠皮内注射诱导、局部诱导和激发实验。激发后除去敷贴片24,48 h后,观察各组动物激发部位皮肤情况,并按Magnusson和Kligman等级分级;激发阶段结束除去敷贴片72 h后,取腹部皮肤组织,显微镜下观察炎症情况。结果与结论:(1)去除敷贴物24,48 h时,实验组和阴性对照组豚鼠腹部激发部位皮肤均未发生红斑及水肿等致敏反应,Magnusson和Kligman等级为0级;阳性对照组豚鼠腹部激发部位皮肤均形成中度融合性红斑或严重红斑及水肿反应,部分可见结痂,Magnusson和Kligman等级为2至3级;(2)实验组和阴性对照组豚鼠腹部激发部位皮肤组织均未见中性粒细胞、淋巴细胞等炎性细胞,未见明显充血、水肿,炎症分级为Ⅰ级;阳性对照组豚鼠腹部激发部位的皮肤组织均可见以中性粒细胞或淋巴细胞为主的炎性细胞浸润反应,炎症分级为Ⅱ-Ⅳ级;(3)结果表明,全内置式可膨胀型生物涂层脊柱前路内固定系统未引起致敏反应,符合作为植入物在迟发性超敏反应实验中的要求。BACKGROUND:Previous experiments have proved that the unique built-in expandable bio-coating anterior spinal fixation system has good biomechanical properties,and it can reconstruct the stability of injured thoracolumbar spine.OBJECTIVE:To evaluate the sensitization of the unique built-in expandable bio-coating anterior spinal fixation system.METHODS:The extraction solution of the internal fixation system was taken as experimental group,the normal saline as negative control group,and 5%formaldehyde as positive control group.Intradermal injection induction,local induction and excitation test were carried out according to the sensitization test at the maximal dosage of GB/T16886.10-2005 Biological Evaluation of Medical Devices-Part 10:Tests for Irritation and Delayed-Type Hypersensitivity.Patch was removed after 24 hours and 48 hours,and the skin conditions of the animals in each group were observed and classified according to the Magnusson and Kligman levels.Skin tissues were performed with biopsy and inflammatory observation under microscope at 72 hours after patch removal.RESULTS AND CONCLUSION:First of all,there was no erythema or edema in the experimental group and negative control group at 24 and 48 hours after removal of the patch.The Magnusson and Kligman levels were 0.However,there were moderate erythema or severe erythema and edema in the positive control group,and some scabs appeared.The Magnusson and Kligman levels were 2-3.Secondly,the experimental group and negative control group showed no stimulate neutrophils,lymphocytes and other inflammatory cells in the abdominal skin of guinea pigs,and there was no obvious hyperemia and edema.The inflammation grade was I.In the positive control group,however,inflammatory cells infiltrated by neutrophils or lymphocytes were seen in the skin tissues at the ventral part of guinea pigs,with an inflammatory grade of II-IV.All the findings reveal that the all built-in expansible bio-coating anterior spinal fixation system did not cause sensitization,which accorded with

关 键 词：钛合金 羟基磷灰石 豚鼠 生物相容性 致敏反应 生物材料 内固定器 羟基磷灰石类 豚鼠 免疫法 组织工程 

分 类 号：R318[医药卫生—生物医学工程]