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可吸收颅骨固定锁辅助兔颅骨损伤修复研究

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目的 以新西兰兔为模型动物,通过观察使用可吸收颅骨固定锁后的模型动物的生理状态、临床表现和病理组织学的变化来评价可吸收颅骨锁修复兔颅骨缺损的安全性和有效性。方法 根据实验目的和实验设计的要求,用105只新西兰兔随机分为试验组、对照组和空白对照组,试验组和对照组分别进行颅骨缺损,并植入供试品和对照品材料,空白对照组仅做缺损,不植入任何材料。在植入后1、2、3、6、9、12、15个月7个时间点进行解剖观察,可吸收颅骨锁植入部位解剖取材观察,行病理分析。研究期间,所有动物行临床观察。结果 研究期间各组动物无明显临床异常,亦无动物死亡。体重在术后9~15个月期间明显增加,血常规和血清生化的检测无明显异常;于各节点观察解剖动物,植入部位周围组织均正常,可吸收颅骨固定锁在各个时间点逐步与周围骨质融合,其与动物自体骨的结合程度越来越紧密,能有效地进行骨瓣复位固定,促进颅骨愈合,病理组织学检查未见感染性炎症反应。结论 在该试验条件下,可吸收颅骨固定锁修复兔颅骨缺损与对照组相比具有类似的修复疗效并能有效地进行骨瓣复位固定,且兔模型试验证明临床安全。
Assisted repair of rabbit skull injury defect with absorbable skull fixing lock
[Objective]Using New Zealand rabbits as an animal model,to evaluate the safety and effectiveness of using absorbable skull locks to repair rabbit skull defects by observing the physiological state,clinical manifestation and pathological histological changes of model animals after using absorbable skull fixed locks.[Methods]According to the requirements of the experimental purpose and experimental design,105 New Zealand rabbits were randomly divided into test groups,control groups and blank control groups.Test groups and control groups respectively underwent skull defects,and were implanted with test products and contrast materials,while blank control groups only had defects and no materials implanted.The animals were sacrificed at 1 month,2 months,3 months,6 months,9 months,12 months and 15 months after surgery for anatomical observation and histopathological analysis.During the study,all animals were clinically observed.[Results]During the study,there were no obvious clinical abnormalities in each group,and there was no animal death.The weight was significantly increased during 9 to 15 months after surgery,and the detection of blood routine and serum biochemistry tests had no significant abnormalities.In the observation of anatomy animals at each time points,the tissue around the implant site was normal,and the absorbable skull fixed lock could be gradually fused with surrounding bone at various time points.The binding degree between it and animal autogenous bone was becoming increasingly close,which can effectively perform bone flap reset,promote cranial healing,and no infectious inflammatory response was found by pathological histological examination.[Conclusion]Under the conditions of this trial,the absorbable skull fixed lock in repairing rabbit skull defect has similar repair results compared with the control group and can effectively perform bone flap reset,and rabbit model test proves clinical safety.

absorbable skull fixing lockskull defectrabbit model

李英俊、张迪、杨飞霞、张志慧、孙立旦、史利军

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北京通和立泰生物科技有限公司,北京 102609

中国农业科学院北京畜牧兽医研究所,北京 100193

可吸收颅骨固定锁 颅骨缺损 兔模型

2024

中国医学工程
中国医药生物技术协会 卫生部肝胆肠外科研究中心

中国医学工程

影响因子:0.504
ISSN:1672-2019
年,卷(期):2024.32(12)