椎体成形术用于实验猪体内骨水泥安全性及有效性评价

doi:10.12300/j.issn.1674-5817.2025.006

摘要/Abstract

摘要：

目的椎体成形术全称为经皮穿刺椎体成形术（percutaneous vertebroplasty，PVP），是临床上向病变椎体内注入骨水泥以达到强化椎体的技术。骨水泥的安全性和有效性研究是其临床应用的基础，本研究采用椎体成形术来评价和比较实验猪体内Tecres和不透射线骨水泥的安全性和有效性，并确定适合猪的穿刺方法以及临床前评价骨水泥安全性和有效性的方法。方法将24头实验用猪（体重60～80 kg）随机分为试验组（A组）和对照组（B组）：A组为Tecres骨水泥组，B组为不透射线骨水泥组，每组12头。在C型臂X射线机的监视下，采用单侧椎弓根入路法经皮穿刺将Tecres骨水泥或不透射线骨水泥植入到猪的第1腰椎（L1）和第4腰椎（L4）中，分别于术后在4周和在26周采用安乐死的方法处死动物，取其L4椎体进行抗压强度测试，取其L1椎体进行硬组织病理学检查，观察植入部位的炎症反应、骨坏死情况以及骨整合程度。结果在骨水泥植入术后第4周和第26周时，A、B两组之间椎体抗压强度的测试结果均无显著差异（P>0.05）。光学显微镜下的（×100）观察结果显示，术后第4周时，A、B两组均可见骨水泥被增生的纤维组织包裹，周边有淋巴细胞浸润，骨水泥与骨组织结合，骨小梁排列紊乱，成骨细胞及少量类骨质形成。术后第26周时，A、B两组均可见骨水泥，以及新生骨组织矿化、骨小梁融合、骨小梁结构规整致密且连续性好，未见明显的炎症反应。结论在实验猪椎骨内，Tecres和不透射线骨水泥的抗压强度、引起的炎症反应、对骨的破坏以及与骨的整合程度均未见明显差异，均具有良好的生物相容性和成骨特性，表明用椎体成形术在猪体内评价骨水泥的安全性和有效性是科学的。

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, 猪

Abstract:

Objective The full name of vertebroplasty is percutaneous vertebroplasty (PVP). It is a clinical technique that injects bone cement into the diseased vertebral body to achieve strengthening of the vertebra. The research on the safety and efficacy of bone cement is the basis for clinical application. In this study, vertebroplasty is used to evaluate and compare the safety and efficacy of Tecres and radiopaque bone cement in experimental pigs, and to determine the puncture method suitable for pigs and the pre-clinical evaluation method for the safety and efficacy of bone cement. Methods Twenty-four experimental pigs (with a body weight of 60-80 kg) were randomly divided into an experimental group (Group A) and a control group (Group B). Group A was the Tecres bone cement group, and Group B was the radiopaque bone cement group, with 12 pigs in each group. Under the monitoring of a C-arm X-ray machine, the materials were implanted into the 1st lumbar vertebra (L1) and 4th lumbar vertebra (L4) of the pigs via percutaneous puncture using the unilateral pedicle approach. The animals were euthanized at 4 weeks and 26 weeks after the operation, respectively. The L4 vertebrae were taken for compressive strength testing, and the L1 vertebrae were taken for hard tissue pathological examination to observe the inflammatory response, bone necrosis, and degree of osseointegration at the implantation site. Results The test results of compressive strength between groups A and B showed no significant difference at 4 weeks and 26 weeks after bone cement implantation (P > 0.05). Observation under an optical microscope (×100) revealed that at 4 weeks postoperatively, both groups A and B showed that the bone cement was surrounded by proliferative fibrous tissue, with lymphocyte infiltration around it. The bone cement was combined with bone tissue, the trabecular arrangement was disordered, and osteoblasts and a small amount of osteoid were formed. At 26 weeks postoperatively, bone cement was visible in both groups A and B. The new bone tissue was mineralized, the trabeculae were fused, the trabecular structure was regular and dense with good continuity, and no obvious inflammatory reaction was observed. Conclusion In experimental pig vertebrae, there were no significant differences observed in the compressive strength, inflammation response, bone destruction, and integration with the bone between Tecres and non-radiopaque bone cement. Both exhibited good biocompatibility and osteogenic properties. It indicates that using vertebroplasty to evaluate the safety and efficacy of bone cement in pigs is scientifically sound.

Key words: Vertebroplasty, Bone cement, Bone filling material, Compressive strength, Hard tissue pathology, Osseointegration, Pigs

中图分类号:

Q95-33

林振华,褚祥宇,魏振西,等. 椎体成形术用于实验猪体内骨水泥安全性及有效性评价[J]. 实验动物与比较医学, 2025, 45(4): 466-472. DOI: 10.12300/j.issn.1674-5817.2025.006.

LIN Zhenhua,CHU Xiangyu,WEI Zhenxi,et al. Evaluation of the Safety and Efficacy of Bone Cement in Experimental Pigs Using Vertebroplasty[J]. Laboratory Animal and Comparative Medicine, 2025, 45(4): 466-472. DOI: 10.12300/j.issn.1674-5817.2025.006.

图/表 2

图1 猪椎体成形术的X射线影像图注：A，定位穿刺点；B，穿刺针达到靶点（侧位）；C，穿刺针达到靶点（正位）；D，骨水泥注入器进入椎体；E，骨水泥注入猪椎体。

Figure 1 X-ray imaging pictures of pig percutaneous vertebroplastyNote： A， Locate the puncture site； B， Puncture needle reaches the target point （lateral position）； C， Puncture needle reaches the target point （anteroposterior position）； D， Bone cement injector enters the vertebral body； E， Bone cement is injected into the porcine vertebral body.

图2 骨水泥植入部位组织的HE和甲苯胺蓝染色结果（×100）注：A，A组术后第4周（HE染色）；B，A组术后第26周（HE染色）；C，B组术后第4周（HE染色）；D，B组术后第26周（HE染色）；E，A组术后第4周（甲苯胺蓝染色）；F，A组术后第26周（甲苯胺蓝染色）；G，B组术后第4周（甲苯胺蓝染色）；H，B组术后第26周（甲苯胺蓝染色）。红色箭头所示为成骨细胞；绿色箭头所示为骨水泥；黑色箭头所示为骨小梁；蓝色箭头所示区域可见炎性细胞浸润；图中比例尺均为200 μm。

Figure 2 HE and toluidine blue staining results of bone cement implantation site tissues （×100）Note： A， Group A at 4 weeks post-surgery （HE staining）； B， Group A at 26 weeks post-surgery （HE staining）； C， Group B at 4 weeks post-surgery （HE staining）； D， Group B at 26 weeks post-surgery （HE staining）； E， Group A at 4 weeks post-surgery （toluidine blue staining）； F， Group A at 26 weeks post-surgery （toluidine blue staining）； G， Group B at 4 weeks post-surgery （toluidine blue staining）； H， Group B at 26 weeks post-surgery （toluidine blue staining）. The red arrows indicate the osteoblast， the green arrows indicate the bone cement， the black arrows indicate the bone trabecula， the blue arrows indicate the area of inflammatory cell infiltration and the scale bars in all figures are 200 μm.

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