目的:磷酸钙骨水泥是一种新型骨移植替代材料,对它的改性研究是近年来的研究热点之一,通过改变磷酸钙骨水泥的流变学,制备可注射性磷酸钙骨水泥更适于微创应用,但应用于临床要对其生物相容性进行评价。方法:实验于2006—10/2007—01在天津医院骨科研究所完成。①实验材料:可注射性磷酸钙骨水泥(由固相与液相两部分组成,固相为碳酸钙、磷酸氢钙等,液相为磷酸钠盐溶液)。②实验动物:新西兰兔14只,体质量2.0-3.5kg,雌雄各半。实验过程中对动物处置符合动物伦理学要求。③实验方法和评估:通过采用可注射性磷酸钙骨水泥浸提液和试件与骨髓基质细胞分别共培养。MTT法测定细胞相对增殖率,进行细胞毒性反应分级,光镜和扫描电镜观察细胞生长形态和生长活性。可注射性磷酸钙骨水泥浸提液进行溶血和热原试验观察。将可注射性磷酸钙骨水泥试件植入兔肌肉内,观察炎症反应和纤维包膜形成情况。结果:14只新西兰兔均进入结果分析。可注射性磷酸钙骨水泥浸提液和试件与骨髓基质细胞共培养,细胞生长形态良好,数量逐渐增加,细胞毒性反应为0~Ⅰ级,基本无毒性。浸提液的溶血率〈0.05%,注入兔耳缘静脉后未引起发热反应。可注射性磷酸钙骨水泥试件植入兔肌肉中观察24周,早期有淋巴细胞浸润,包膜形成,晚期淋巴减少或消失,包膜稳定,无增厚趋势,未见有白细胞浸润。结论:可注射性磷酸钙骨水泥具有良好的生物相容性,符合植入人体生物材料的细胞毒性要求,对机体不会造成不良影响,因而临床可以安全使用。
AIM: Calcium phosphate cement is a novel bone graft material, and its modification has become one of the hot topic in recent researches. This study was designed to prepare injectable calcium phosphate cement (ICPC) by changing the rheology of calcium phosphate cement, evaluate bicompatibility and apply ICPC on minimal invasion in clinics. METHODS: The experiment was carried out in the Orthopaedics Institute of Tianjin Hospital from October 2006 to January 2007.(1)ICPC included solid phase (CaCO3 and calcium phosphate, etc) and liquid phase (sodium phosphate solution). (2)Fourteen New Zealand rabbits, weighing 2.0-3.5 kg, of either genders, were used in the study. All the animals were managed in accordance with the ethical standard of animals. (3)Marrow stroma cells were co-cultured with ICPC extracting solution or cement specimen. Cell relative growth rate was measured by MTT methods. And cell-cytotoxic reaction was also graded. Cell morphology and activity were detected under light microscope and scanning electron microscope. ICPC specimens were implanted in rabbit muscle to evaluate inflammation reaction and fibrous capsule formation. Hemolytic test and pyrogen test were performed in the ICPC extracting solution. RESULTS: All the 14 New Zealand rabbits were involved in the result analysis. Marrow stroma cells grew well with toxicity rank of zero to one grade when co-cultured with ICPC extracting solution or cement specimen. The hemolysis rate was no more than 0.05% and no pyrogenetic reaction occurred after injecting extracting solution into vein of rabbit ears. ICPC specimens were implanted in rabbit muscle for 24 weeks. Lymphocytes infiltrating and fibular capsule formation were found in the early stage, while lymphocytes decreased or disappeared and capsule became stable in the late stage, without the presence of thickening capsule or leukocytic infiltration. CONCLUSION: ICPC has excellent biocompatibility and fits cytotoxicity requirement for biomaterials, which will be impla