Siebert H R, Wagner K, Rueger J M
Unfallchirurgie. 1986 Apr;12(2):98-100. doi: 10.1007/BF02588329.
In clinical practice, biologic and synthetic substances have been used more and more as bone substitutes during the last few years. Different properties of the implant material are required according to the various fields of application. This implies a precise investigation of the biologic value by adequate experimentations on animals. It has been demonstrated in a bioassay with several synthetic implant materials, especially ceramics made of calcium phosphate, powders and granulated materials of tricalcium phosphate, and hydroxylapatite with different pore sizes and numbers, that there is only poor or even not any biologic activity in these substances which would produce an orthotopic stimulation of osseous formation. The application of these substances as bone substitutes can only be recommended in an adequate transplantation bed. However, all implant materials tested by different experimentations on animals showed an incomplete absorption in the histomorphological investigation even after twelve months. The various biologic bone substitutes (autologous and homologous spongiosa, demineralized homologous spongiosa, different forms of bone gelatin) show different degrees of biologic activity. Hitherto an inducing heterotopic effect could be demonstrated for bone gelatin in rats, dogs, and sheep. The inducing effect of bone gelatin combined with soluble calcium phosphate ceramics in rats was increased as compared with autologous spongiosa. Regarding our own results as well as various communications in literature, we consider it absolutely necessary to give more attention to the objectifying criteria when describing the biologic activity of "biologic and synthetic bone substitutes".
在临床实践中，在过去几年里生物和合成物质越来越多地被用作骨替代物。根据不同的应用领域，对植入材料有不同的性能要求。这意味着要通过在动物身上进行充分的实验来精确研究其生物学价值。在一项对几种合成植入材料的生物测定中已经证明，特别是由磷酸钙制成的陶瓷、磷酸三钙的粉末和粒状材料以及具有不同孔径和孔数的羟基磷灰石，这些物质中只有微弱的甚至没有任何能产生原位骨形成刺激的生物学活性。这些物质作为骨替代物的应用仅在合适的移植床中才被推荐。然而，通过在动物身上进行的不同实验测试的所有植入材料，即使在十二个月后，在组织形态学研究中都显示出不完全吸收。各种生物骨替代物（自体和同种异体松质骨、脱矿同种异体松质骨、不同形式的骨明胶）表现出不同程度的生物学活性。迄今为止，在大鼠、狗和绵羊身上已证明骨明胶具有诱导异位效应。与自体松质骨相比，骨明胶与可溶性磷酸钙陶瓷联合在大鼠中的诱导作用增强。鉴于我们自己的结果以及文献中的各种报道，我们认为在描述“生物和合成骨替代物”的生物学活性时，绝对有必要更加关注客观标准。
