实验动物与比较医学

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椎体成形术用于实验猪体内骨水泥安全性及有效性评价

林振华(), 褚祥宇()(), 魏振西, 董传俊, 赵增琳, 孙晓霞, 李庆雨, 张琪   

  1. 山东省医疗器械和药品包装检验研究院, 国家药品监督管理局生物材料器械安全性评价重点实验室, 济南 250101
  • 发布日期:2025-05-14
  • 通讯作者: 褚祥宇(1988—),女,本科,工程师,主要从事医疗器械生物学评价工作。E-mail: cxy180331@163.com。ORCID: 0009-0001-6842-290X
  • 作者简介:林振华(1985—),男,本科,高级兽医师,主要从事大动物临床前医疗器械有效性及安全性评价工作。E-mail: 86246889@qq.com
  • 基金资助:
    十四五国家重点研发计划“新型骨科生物医用材料及产品安全性和有效性评价技术研究”(2022YFC2401801)

Evaluation of the safety and efficacy of bone cement in experimental pigs using vertebroplasty

LIN Zhenhua(), CHU Xiangyu()(), WEI Zhenxi, DONG Chuanjun, ZHAO Zenglin, SUN Xiaoxia, LI Qingyu, ZHANG Qi   

  1. Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection; NMPA Key Laboratory for Safety Evaluation of Biomaterials and Medical Devices, Jinan 250101, China
  • Published:2025-05-14
  • Contact: CHU Xiangyu (ORCID:0009-0001-6842-290X), E-mail: cxy180331@163.com

摘要:

目的 在临床前动物实验中确定适合猪的穿刺方法以及骨水泥的安全性及有效性评价方法。 方法 将24头实验用猪(体质量60~80 kg)随机分为A、B两组[A组为Tecres骨水泥组,B组为不透射线骨水泥(Spine-Fix Radiopaque Bone Cement)组],每组12头。在C型臂X射线机监视下,单侧椎弓根入路法经皮穿刺将材料植入到猪的腰椎L1和腰椎L4节椎体内,分别于术后4周、26周采用安乐死方法处死动物,取动物的腰椎L4节椎体进行抗压强度测试、取动物的腰椎L1节椎体进行硬组织病理学检查,观察植入部位的局部炎症反应、骨坏死情况与骨整合程度。 结果 A、B两组之间抗压强度测试结果在4周、26周时均无统计学差异(P>0.05)。术后4周,A、B两组镜下均可见试验样品,均可见骨水泥被增生的纤维组织包裹,周边均可见以淋巴细胞浸润为主的炎症反应,均可见试验样品与骨组织结合,骨小梁排列紊乱,两组均可见成骨细胞及少量类骨质形成。术后26周,A、B两组镜下均可见试验样品,新生骨组织逐渐矿化,骨小梁逐渐融合,骨小梁结构变得规整致密,连续性变好,未见明显炎症反应。 结论 A、B两组之间抗压强度、植入部位的局部炎症反应、骨坏死情况与骨整合程度均未见明显差异。

关键词: 椎体成形术, 骨水泥, 骨填充材料, 抗压强度, 硬组织病理, 骨整合,

Abstract:

Objective To determine the appropriate puncture method for pigs and the evaluation methods of the safety and effectiveness of bone cement in preclinical animal experiments. Methods Twenty-four Yorkshire pigs with a body mass of 60 to 80 kg were randomly divided into two groups, group A and group B. Group A was the Tecres bone cement group, and group B was the Spine-Fix Radiopaque Bone Cement group, with 12 pigs in each group. Under the surveillance of a C-arm X-ray machine, the materials were percutaneously implanted into the vertebral bodies of lumbar vertebrae L1 and L4 of the pigs through the unilateral pedicle approach. At 4 weeks and 26 weeks after the operation, the animals were euthanized by the euthanasia method. The vertebral body of lumbar vertebra L4 of the animals was taken for compressive strength testing, and the vertebral body of lumbar vertebra L1 was taken for hard tissue pathological examination to observe the local inflammatory reaction, bone necrosis, and bone integration degree at the implantation site. Results There was no statistical difference in the compressive strength test results between group A and group B at 4 weeks and 26 weeks (P>0.05). At 4 weeks after surgery, the test samples could be seen under the microscope in both group A and group B. The test samples were wrapped by proliferative fibrous tissue, and inflammatory reactions mainly characterized by lymphocyte infiltration could be seen around them. The combination of the test samples and bone tissue could be seen, and the trabecular bone was disordered. Osteoblasts and a small amount of osteoid formation could be seen in both groups. At 26 weeks after surgery, the test samples could be seen under the microscope in both group A and group B. The newly formed bone tissue was gradually mineralized, the trabecular bone was gradually fused, the trabecular bone structure became regular and dense, and the continuity became better. No obvious inflammatory reaction was seen. Conclusion There were no significant differences in compressive strength, local inflammatory reaction at the implantation site, osteonecrosis condition, and degree of osseointegration between Group A and Group B.

Key words: Vertebroplasty, PMMA, Osteoplastic material, Compressive strength, Hard tissue pathology, Osseointegration, Pig

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