复合珊瑚羟基磷灰石人工骨的研制和临床应用

Preparation of the Composite rhBMP_2/CHA Bone Graft Substitutes and Clinical Application

目的 自行研制复合人工骨并评价其临床应用价值。方法 将天然海珊瑚碳酸钙在特定条件下经过“热液交换反应”先制成一种珊瑚羟基磷灰石 (CorallingHydroxyAptite,CHA)人工骨。再将此CHA人工骨与重组人BMP2 (rhBMP2 )和 2 %几丁糖复合 ,制备成rhBMP2 /CHA复合人工骨。将此新型复合人工骨分别植入 2 0只SD大白鼠体内 ,观察其生物相容性和成骨能力。并应用临床治疗骨缺损和椎间融合共 30例 ,观察术后局部伤口情况 ,全身反应和骨愈合情况。结果 随访观察平均 14个月 ,无全身性异常反应 ,仅 1例伤口有渗液 ,3周内伤口愈合 ,其余无不良反应 ,伤口均在 2周内一期愈合。骨愈合情况 :骨囊肿和胫骨干骺端骨折骨缺损植骨后 2个月愈合 ;脊柱椎间融合术后 3个月融合 ;骨不连术后 4～ 6个月愈合 ,无并发症发生。人工骨在观察期内未能完全降解。结论 自行研制的rhBMP2 /CHA复合人工骨生物相容性好 ,无毒性 ,成骨诱导作用优于单纯CHA和异体脱钙骨 ,临床应用满意 ,是一种比较理想的骨移植替代物。

Objective To prepare composite rhBMP 2/CHA bone graft substitutes and evaluate its value of clinical application.Methods At first,the Coralline Hydroxy Apatite (CHA) as a bone garft sbstitute was formed from coral skeletal carbonete by“Hydrothermal exchange” at specificed condition.At second,the composite rhBMP 2/CHA bone fgaft substitute was formed from CHA and rhBMP 2 with 2% chitin.The biological nature and capability of producing new bone were defined by implanting it to 20 SD rats.The clinical value of repairing bone defect was defined by clinical application in 30 patients with fracture,bone tumour and spinal disease.Results Thirty cases were followed up from 6 to 24 months.There were no abnormal reactions of physique.There was leak out at implanting local in 1 case,the others was all normal at implanting local.The Lane-Sandhu evaluate standard was applied to evaluate fracture healing of 30 cases after implanting it.The results of study demonstrated that the rate of excellent of fracture healing of the group bone graft substitutes was better than the group allogenic decalcified bone.Conclusion The composite rhBMP 2/CHA bone grafte substitutes may be excellent bone graft subsititute at clinical applicalion.