新型生物型硬脑膜补片的安全及有效性

背景：目前应用的硬脑膜修补材料有自体组织修补材料、同种异体材料、异种生物材料和人工合成材料等，主要以进口产品为主，价格昂贵。目的：通过动物实验评价一种国产新型生物型硬脑膜补片的安全性和有效性。方法：取24只健康家犬制作双侧硬脑膜缺损模型，左侧植入国产新型生物型硬脑膜补片作为实验组，右侧植入已上市的某品牌人工硬脑膜产品作为对照组。植入后1，3，6，12个月，采用苏木精-伊红染色法比较两组硬脑膜替代物生长、周围组织反应、降解及血管生成情况，荧光分光光度法检测环氧交联剂在犬血液及脑脊液的残留情况。结果与结论：在植入1-12个月期间，实验动物生长状况良好，未见感染和运动障碍等并发症。病理切片显示两组硬脑膜替代材料生物相容性良好，无炎症或仅有轻微炎症反应；植入6个月，实验组补片表层已经退化，并形成由原植入物胶原纤维与新生结缔组织交织在一起的“过渡态结构”，对照组材料无降解；植入12个月，实验组补片有近50%降解，替代材料有新生血管生成，对照组降解30%，仅少量样本可见新生血管。术后1，3，7，14 d，犬血液和脑脊液均未检出交联剂环氧化合物。实验表明这种新型生物型硬脑膜补片是一种安全、有效的理想硬脑膜修补材料。

Safety and validity of a new-type biological dura patch

BACKGROUND：Dural repair materials in current application mainly include autologous tissue repair material, alograft material, heterogeneous biological material and synthetic material, most of which are imported products with expensive price. OBJECTIVE： To evaluate safety and efficacy of a new biological type dura mater patch made in China based on animal experiments. METHODS：Bilateral dura mater defect models were established in 24 healthy domestic dogs： on the left side of the implant model, a new type biological dura patch was transplanted as experimental group; on the right side, another brand artificial dura patch that was on sale was transplanted as control group. After 1, 3, 6 and 12 months of implantation, we compared degradation, angiogenesis, growth and surrounding tissue reaction of dural substitutes of the experimental group and control group by hematoxylin-eosin staining, detected residual dose of epoxy-cross-linked agent in dogs’ blood and cerebrospinal fluid by fluorescence spectrophotometry. RESULTS AND CONCLUSION： During 1-12 months of implantation, al dogs grew wel and no infection or motor disorder was observed. Pathological examination showed that dura substitutes of the experimental group and control group had good biocompatibility, no or slightly inflammatory response. After 6 months of implantation, the surface of the new biological dural substitute （experimental group） was degraded and became a transit-state biomaterial with surrounding tissue, but the control group materials showed no degradation. After 12 months of implantation, the dura patch in the experimental group degraded nearly 50%, which appeared withneovascularization; while, the dura patch in the control group degraded 30%, and neovascularization was observed in only a smal amount of samples. Epoxy compounds of cross-linked agent were not detected in dogs’ blood and cerebrospinal fluid after 1, 3, 7 and 14 postoperative days. These findings show that this new type of biological dural substitute is a safe and ef