生物材料有效性和安全性评价的现状与趋势

The Actuality and Trend of Biomaterial Effectiveness and Safety Evaluation

对生物材料进行有效性和安全性评价是生物材料进入临床前的关键环节。从细胞和组织的水平 ,利用形态学的检测方法观察材料与机体短期和长期的互作关系是以往评价生物材料的主要内容和手段。新型生物材料近年来迅猛发展 ,材料的组成、形态、植入部位及用途日趋复杂 ,对材料的评价相应提出了更高的要求。发展快速、特异、系统的评价体系至关重要。体外实验因操作可控性强 ,影响因素单一 ,重复性好而得到大力的发展 ,通过体内 -体外实验的相关分析有望部分代替体内实验。近交大动物的开发为生物材料的体内评价更接近人体的真实反应提供了新的契机。近几年来 ,大量分子生物学的先进检测手段的应用使生物材料的评价向细胞和分子水平迈进。 RT-PCR、核酸 /蛋白质杂交技术可以从分子的层面寻找材料和机体互作的重要的分子标记 ,而显微探测技术 (如 CON-FU CAL)等的应用通过对图像的三维重建而达到对材料 -细胞、材料 -组织、细胞 -组织相互作用清晰而透彻的观察。总之。三“R”原则 (replace refine reduce)即发展体外实验 ;采用灵敏、特异、先进的检测手段 ;优化并减少实验动物数量 ,建立材料对分子、细胞、机体互作的系统性评价是生物材料评价的发展趋势和最终目的。

The evaluation of biomaterial effectiveness and safety is a key step before the biomaterial approaches to clinics. In recent years, lots of new biomaterials with different composition, shape, implant site and use have been coming out and in need of more special, sensitive and systematic evaluation methods. With the development of immunology, microdetective technique, inbred strain mammal and other connective branches, there are many chances for the consummation and integration of biomaterial evaluation system.The three 'R' principle (replace, refine, reduce), that is, developing in vitro experiments, using sensitive, special and advanced evaluation methods, improving and reducing the member of experimental animals, as well as the fundamental rule, that is, establishing an evaluation system covering three levels (molecule, cell and body) will guide the research of biomaterial evaluation to more promising development.