生物可降解补片兔硬脑膜缺损修复研究

Repair of rabbit dura mater defect with biodegradable patch

目的以新西兰兔为动物模型,通过观察硬脑膜模型动物使用该生物可降解补片后的生理状态、临床表现以及病理组织学改变,以此评价该补片修复硬脑膜缺损的安全性和有效性。方法根据研究目的和设计要求,60只新西兰大白兔被随机分为供试品组、对照品组和空白对照品组3组。将供试品和对照品植入局部,设定30 d、90 d、180 d三个时间点进行观察,取下硬脑膜创伤组织行组织病理学分析。研究期间,所有动物进行临床观察。结果供试品组和对照品组补片均能在术后30 d将硬脑膜外口愈合,实验期间供试品组和对照品组动物无明显临床异常,动物生存率无差别;空白组死亡3只。于观察各时间点解剖动物,180 d生物可降解补片已降解。组织病理学检查未见感染性炎症反应。结论在本试验条件下,可降解补片兔硬脑膜修复与对照品组相比具有类似的修复疗效与防脑脊液渗漏效果,且兔模型试验证明临床安全。

【Objective】Using New Zealand rabbits as an animal model,safety and efficacy of biodegradable patch repairing the defects of the rabbits dura mater were evaluated by observing the physiological state,clinical manifestations and pathological changes.【Methods】According to the trial purpose and design requirements,60 New Zealand white rabbits were randomly divided into three groups:the trial group,the control group and the blank group.Three research points(30 d,90 d,180 d)were set to observe safety and efficacy of patches repair with pathological histological method.All animals were clinically observed during the study.【Results】Both the trial group and the control group were able to heal dura mater defects after 30 d,and there were no significant clinical abnormalities in the trial group and the control group animals,and there was no difference in animal survival rate.In observing the anatomy of animals at various research points,the biodegradable patch was degraded after 180 days.Pathological histological examination did not see any infectious inflammatory response.【Conclusion】Under the conditions of this study,the biodegradable patch had similar recovery effect and anti-cerebrospinal fluid leakage effect compared with the control group.The rabbit model trial proved clinical safety of the biodegradable patch.