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聚丙交酯/矿化胶原人工骨材料在兔桡骨缺损修复中的应用
Application of polylactide/mineralized collagen materials in the repair of radius defects in rabbits
投稿时间:2025-07-07  
DOI:10.3969/j.issn.1672-5972.2026.01.016
中文关键词:  聚丙交酯  矿化胶原  人工骨  骨缺损  骨修复
英文关键词:Polylactide  Mineralized collagen  Artificial bone  Bone defect  Bone repair
基金项目:国家重点研发计划项目(2023YFC2412300)
作者单位邮编
何志敏* 奥精医疗科技股份有限公司,北京,102609 102609
宋天喜* 奥精医疗科技股份有限公司,北京,102609
清华大学材料学院,北京,100084 
100084
王华 奥精医疗科技股份有限公司,北京,102609 102609
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中文摘要:
      目的 以36只新西兰兔桡骨缺损模型评估聚丙交酯/矿化胶原人工骨材料的安全性、有效性及降解特性,为人工骨材料的临床应用提供依据。方法 将36只新西兰兔随机分为供试品组1(人工骨材料)、供试品组2(人工骨材料+自体骨)及对照品组(自体骨),通过大体解剖,影像学及病理组织学诊断考察了术后即刻、6周、12周、24周、36周的人工骨修复效果。结果 所有动物术后恢复良好,无死亡、感染或免疫排斥反应。人工骨材料于植入后6周,材料形态完整,无明显降解,缺损部位长出新生骨组织;术后12周人工骨材料开始降解,新生骨组织能完全封闭骨缺损部位;术后24周人工骨材料大部分被骨基质、破骨细胞、骨小梁取代;术后36周人工骨材料降解完全,缺损部位修复良好。结论 聚丙交酯/矿化胶原人工骨材料具有良好的生物相容性、可降解性和骨诱导活性,能有效地与新生骨质融合,是良好的人工骨移植材料。
英文摘要:
      Objective To evaluate the safety, efficacy, and degradation characteristics of an artificial bone repair material in a thirty-six rabbits radial defect model and provide evidence for its clinical application.Methods Thirty-six New Zealand rabbits were randomly divided into three groups: Test Group 1 (artificial bone repair material alone), Test Group 2 (artificial bone repair material combined with autologous bone), and a Control Group (autologous bone alone). Postoperative evaluations at 0, 6, 12, 24, and 36 weeks included gross anatomy, imaging, and histopathological analysis to assess bone repair outcomes.Results All animals recovered well postoperatively, with no mortality, infection, or immune rejection observed. At 6 weeks, the artificial bone material remained structurally intact with minimal degradation, while new bone tissue had begun forming in the defect area. By 12 weeks, the material exhibited signs of degradation, and the defect site was fully bridged by newly formed bone. At 24 weeks, most of the artificial bone had been replaced by bone matrix, osteoclasts, and trabeculae. Complete degradation of the material and satisfactory bone regeneration were achieved by 36 weeks.Conclusion The polylactide/mineralized collagen artificial bone repair material exhibits good biocompatibility, degradability, and osteoinductive activity, effectively integrating with newly formed bone tissue. It is a promising artificial bone graft material.
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