国产猪小肠黏膜下层脱细胞基质用于兔硬脑膜修复的效果及安全性  

Effectiveness and Safety of a Domestic Porcine Small Intestinal Submucosa Acellular Matrix in Rabbit Dura Mater Repairing

作　　者：孙立旦 杨飞霞 张迪 陈泽良 张志慧 李英俊 史利军[3] SUN Lidan;YANG Feixia;ZHANG Di;CHEN Zeliang;ZHANG Zhihui;LI Yingjun;SHI Lijun(College of Animal Science and Veterinary Medicine,Shenyang Agricultural University,Shenyang 110866,China;Beijing Tonghe Litai Biotechnology Co.,Ltd.,Beijing 102609,China;Institute of Animal Sciences,Chinese Academy of Agricultural Sciences,Beijing 100193,China)

机构地区：[1]沈阳农业大学动物科学与医学学院,沈阳110866 [2]北京通和立泰生物科技有限公司,北京102609 [3]中国农业科学院北京畜牧兽医研究所,北京100193

出　　处：《实验动物与比较医学》2022年第1期36-41,共6页Laboratory Animal and Comparative Medicine

基　　金：北京市重大关键任务科技支撑课题:医疗器械研发与一致性评价公共服务平台(Z191100005619015)。

摘　　要：目的以新西兰白兔构建硬脑膜缺损模型,通过观察使用国产猪小肠黏膜下层脱细胞基质补片后动物的生理状态、临床表现以及病理组织学改变,评价可降解补片修复硬脑膜缺损的有效性和安全性。方法用48只新西兰白兔制作硬脑膜缺损模型,并随机分为试验组和对照组,每组24只,分别植入国产的猪小肠黏膜下层脱细胞基质补片(供试品)和国外市售的生物硬脑膜修补片(对照品),然后观察术后两组动物的基本情况。植入术后7 d、30 d、60 d、90 d共4个时间点分别检测兔血液学及血生化指标变化,然后安乐死动物,解剖观察硬脑膜修复情况,并取硬脑膜创伤组织进行病理组织学分析。实验期间,对所有动物进行兽医临床观察。结果试验组和对照品组兔均能在术后30 d硬脑膜外口愈合,两组动物临床行为学观察无明显异常,存活率也无差异。此外,植入术后各时间节点的兔血液学及生化指标均无明显变化(P>0.05),且解剖动物后观察证实两组间硬脑膜修复过程无明显差别,病理组织学检查也未见感染性炎性反应。结论用猪小肠黏膜下层脱细胞基质修复兔硬脑膜,与市售材料相比,具有类似的硬脑膜修复疗效与防脑脊液渗漏效果,证明了其安全性和有效性。Objective Using New Zealand white rabbits as an animal model,the effectiveness and safety of a domestic porcine small intestinal submucosa(SIS)acellular matrix in repairing rabbit dura mater defects were evaluated by observing the physiological state,clinical manifestations,and pathological changes.Methods Forty-eight New Zealand white rabbits were randomly divided into a trial group(n=24)and a control group(n=24).The domestic SIS and commercially available materials(control)were implanted by surgery.The animals were sacrificed at 7,30,60,and 90 days after surgery for anatomical observation and histopathological analysis.All the animals were clinically observed during the study.Results Both SIS materials were able to heal the dura mater 30 days after surgery.There were no obvious clinical abnormalities or significant differences in animal survival rates between the two groups.The morphological changes showing tissue reconstruction were similar at multiple time points,and no infectious inflammatory responses were observed following pathological histological examination in either group.Conclusion Under the conditions of this trial,the repairing effect of the tested domestic SIS was similar to that ovserved in the control group,demonstrating that this type of SIS is an ideal material for dura mater repair.

关 键 词：猪小肠黏膜下层 脱细胞基质 硬脑膜 兔模型 

分 类 号：Q95-33[生物学—动物学]