经皮椎体（后凸）成形术治疗椎体骨坏死的可吸收丝素基硫酸钙骨水泥的研制

Osteoporotic vertebral fractures with osteonecrosis are often not recognized in the past. But with the development of medical imaging and minimally invasive spine surgery, people found that the disease is common. As vertebral fracture was developing into bone necrosis, it would not self healing, and open surgery is not preferred. Percutaneous vertebroplasty or kyphoplasty became the main treatment method because of minimally invasive technology. But vertebral body filler in percutaneous vertebroplasty and kyphoplasty is no biological activity, not degrading or insufficient strength, cannot support the fracture vertebra..This project aims to add silk fibroin to calcium sulfate cements to enhance strength of the cement and anti-scattered research, achieve good combination of organic materials and inorganic materials. The solidification time, mechanical strength and degradation rate of the silk fibroin /calcium sulfate cement were regulated by additives such as silk fibroin composition. Select the appropriate ratio of silk fibroin /calcium sulfate cements and add BMP to it, thus prepare a good strength and speed degradation, bone conduction and induction of new injectable artificial bone. If this project was supported, patients with vertebral necrosis will get a minimally invasive and effective treatment, reducing the burden of family and community. There are good for economic, social and developing prospects.

骨质疏松性椎体骨折后发生的骨坏死过去不常被人们认识。但随着医学影像技术的发展及微创脊柱手术的开展，人们发现这种疾病并不少见。椎体骨折一旦发生骨坏死，不会自身愈合，而开放手术并非首选，经皮椎体（后凸）成形术因微创倍受青睐，成为主要的治疗方法。但目前用于椎体（后凸）成形术的椎体填充剂存在无生物活性、不能降解或强度不够，不能支撑椎体等缺点。 .本项目拟采用添加丝素蛋白的方法对硫酸钙骨水泥进行增强和抗稀散研究，达到有机材料与无机材料的良好结合，并通过调节丝素蛋白等添加剂的组成比，调控丝素蛋白/硫酸钙复合骨水泥的凝固时间、力学强度与降解速率；选择合适配比的丝素蛋白/硫酸钙骨水泥，加入BMP，制备出一种具有较好强度和降解速度，骨传导和骨诱导作用的新型可注射人工骨。本项目如能得到资助，将能使这些椎体骨坏死患者得到一种微创有效的治疗，减轻家庭与社会的负担，有良好的经济、社会效益与发展前景。

项目以研制治疗椎体骨坏死的新型丝素蛋白/硫酸钙/骨形态发生蛋白（SF/CS/BMP）复合骨水泥为目标，研究了丝素蛋白对硫酸钙骨水泥的生物相容性及力学性能的影响，发现通过调整丝素蛋白的配比，可以改善磷酸钙骨水泥的抗压强度、抗溃散性、凝固时间，并发现当丝素蛋白浓度为6%，液固比为0.4ml／g时可以达到良好的力学性能。项目通过体外细胞实验证实了所研制的骨水泥具有良好的生物相容性。最后建立椎体骨质缺损大动物模型，研究该复合骨水泥复合材料的成骨性及在体内的力学变化情况。该复合骨水泥具有良好的生物相容性和力学性能，在治疗椎体骨坏死的椎体（后凸）成形术中具有良好的应用前景。目前，该骨水泥的体外制备与实验已完成，由于项目最后部分为大动物体内实验，动物造模前饲养及造模实际时间大于预期，导致项目进展时间比预期稍有滞后，相关数据汇总、论文撰写将比预期滞后半年左右。.本项目共发表论文9篇，其中SCI收录4篇，SCI已接收1篇。培养硕士研究生3名。