可吸收椎体内支撑器体内降解观察研究

In Vivo Degradation Analysis of Centrum-vertebra-fracture Repairing Absorbable Supporting Plugger

目的:评价不同配方可吸收椎体内支撑器体内降解过程、降解速率和降解产物安全性。方法:80只新西兰兔,雌雄各半,2.5±0.3kg,随机分2组(6%β-TCP/PDLLA、PDLLA组),每组40只。臀大肌内植入支撑器,术后定期取材,评价不同配方支撑器的降解过程、速率及安全性。结果:(1)所有动物术后一般情况良好,试验周期内,肌肉紧密包裹材料,无感染、化脓、组织液化。(2)6%β-TCP/PDLLA材料降解过程中形态变化及质量损失平稳,与纯PDLLA材料比较有显著差异性(β<0.05)。结论:(1)2种材料均有良好的生物相容性;(2)6%β-TCP/PDLLA材料降解过程较纯PDLLA材料平稳,可能是较为理想的椎体重建可吸收复合材料。

Objective： To evaluate the the degradation process,degradation rate and degradation product safety between different formulations Centrum-vertebra-fracture-repairing absorbable supporting plugger（CASP） by implantation in vivo.Methods： 80 New Zealand rabbits（half male and female,2.5±0.3kg）,were randomly divided into 2 groups（6%β-TCP/PDLLA,PDLLA group）.CASP implanted in vivo,evaluation of the degradation process,speeds and safety of different materials.Results： All animals in good condition after implanting,in Test cycle,muscle closely wrapped materials,no infection,suppuration,organize liquefaction.Materials which formula is 6%β-TCP/PDLLA,morphological change and mass loss is stable in degradation process,compared with another materials have significant differences（P0.05）.Conclusions： Two materials have good biocompatibility,2.6% β-TCP/PDLLA materials＇mass loss is stable than another materials in degradation process,probably is a more satisfactor materials can be use for Vertebral body reconstruction.