Ladd A L, Pliam N B
Divisions of Hand Surgery and Orthopaedic Surgery, Stanford University School of Medicine, Palo Alto, CA 94304, USA.
J Am Acad Orthop Surg. 1999 Sep-Oct;7(5):279-90. doi: 10.5435/00124635-199909000-00001.
The development of bone-graft substitutes potentially provides the benefits of bone grafting without the risks of autograft harvest. During the past few years, the US Food and Drug Administration has approved several different types of products. These vary considerably in composition, structural strength, osteoinductive and osteoconductive potential, and mechanisms and rates at which they are resorbed or remodeled. The products now approved for orthopaedic applications in the United States include those based on naturally occurring materials (e.g., demineralized human bone matrix, bovine collagen mineral composites, and processed coralline hydroxyapatite) as well as synthetic materials (e.g., calcium sulfate pellets, bioactive glass, and calcium phosphate cement). Materials in development include variations on available products and a new generation of biologically active materials employing growth factors. Rigorous comparison of the products is difficult, as there are no universally accepted preclinical assays and comparable clinical studies. Despite the limitations of the data now available, controlled studies and anecdotal reports suggest that use of bone-graft substitutes may result in improved treatment outcomes for patients with fractures of the distal radius.
骨移植替代物的发展有望在不承担自体骨采集风险的情况下提供骨移植的益处。在过去几年中，美国食品药品监督管理局已批准了几种不同类型的产品。这些产品在成分、结构强度、骨诱导和骨传导潜力以及它们被吸收或重塑的机制和速率方面有很大差异。目前在美国被批准用于骨科应用的产品包括基于天然材料的产品（如脱矿人骨基质、牛胶原矿物质复合材料和加工过的珊瑚羟基磷灰石）以及合成材料（如硫酸钙颗粒、生物活性玻璃和磷酸钙骨水泥）。正在研发的材料包括现有产品的变体以及采用生长因子的新一代生物活性材料。由于没有普遍接受的临床前检测方法和可比的临床研究，对这些产品进行严格比较很困难。尽管现有数据存在局限性，但对照研究和轶事报告表明，使用骨移植替代物可能会改善桡骨远端骨折患者的治疗效果。
