White Andrew P, Vaccaro Alexander R, Hall Jeremy A, Whang Peter G, Friel Brian C, McKee Michael D
Carl J. Shapiro Department of Orthopaedics, Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Stoneman 10, 330 Brookline Ave, Boston, MA, 02215, USA,
Int Orthop. 2007 Dec;31(6):735-41. doi: 10.1007/s00264-007-0422-x. Epub 2007 Jul 25.
Since the identification of the osteogenic protein-1 (OP-1) gene, also called bone morphogenetic protein-7 (BMP-7), almost 20 years ago, OP-1 has become one of the most characteristic members of the BMP family. The biological activity of recombinant human OP-1 has been defined using a variety of animal models. These studies have demonstrated that local implantation of OP-1 in combination with a collagen matrix results in the repair of critical size defects in long bones and in craniofacial bones and the formation of bony fusion masses in spinal fusions. Clinical trials investigating long bone applications have provided supportive evidence for the use of OP-1 in the treatment of open tibial fractures, distal tibial fractures, tibial nonunions, scaphoid nonunions and atrophic long bone nonunions. Clinical studies investigating spinal fusion applications have provided supportive evidence for the use of OP-1 in posterolateral lumbar models and compromised patients as an adjunct or as a replacement for autograft. Both long bone repair and spinal fusion studies have demonstrated the efficacy and safety of OP-1 by clinical outcomes and radiographic measures. Future clinical investigations will be needed to better define variables, such as dose, scaffold and route of administration. Clearly the use of BMPs in orthopaedics is still in its formative stage, but the data suggest an exciting and promising future for the development of new therapeutic applications.
自大约20年前成骨蛋白-1(OP-1)基因(也称为骨形态发生蛋白-7(BMP-7))被鉴定以来,OP-1已成为骨形态发生蛋白(BMP)家族中最具代表性的成员之一。重组人OP-1的生物活性已通过多种动物模型得以确定。这些研究表明,将OP-1与胶原基质联合进行局部植入可修复长骨和颅面骨的临界尺寸缺损,并在脊柱融合中形成骨融合块。针对长骨应用的临床试验为OP-1用于治疗开放性胫骨骨折、胫骨远端骨折、胫骨骨不连、舟状骨骨不连和萎缩性长骨骨不连提供了支持性证据。针对脊柱融合应用的临床研究为OP-1用于后外侧腰椎模型以及病情复杂的患者作为自体骨移植的辅助手段或替代物提供了支持性证据。长骨修复和脊柱融合研究均已通过临床结果和影像学测量证明了OP-1的有效性和安全性。未来还需要进行临床研究,以更好地确定诸如剂量、支架和给药途径等变量。显然,骨形态发生蛋白在骨科领域的应用仍处于发展阶段,但现有数据表明其在开发新治疗应用方面有着令人兴奋且充满希望的前景。