PDS血管外支架体外毒性和体内相容性的实验研究

Biocompatibility and biological safety of the external stent material polydioxanone in vitro & in vivo study

目的观察血管外支架材料聚对二氧环己酮(PDS)的体外毒性和体内生物相容性。方法按照医疗器械生物学评价标准,采用体外细胞培养法、MTT法进行PDS体外细胞毒性试验,并进行体内植入降解实验。结果PDS网状支架材料对细胞形态、生长代谢和增殖不构成损害;PDS在体内12周左右开始加速降解,24周完全降解吸收,炎性反应也减退消失,材料区域被新生纤维组织取代,降解过程中未对周围组织产生不良刺激。结论PDS支架材料无细胞毒性,组织反应轻,可满足体内植入的要求。

[ Objective] To evaluate the biocompatibility and biological safety of the external stent material polydioxanone（PDS） by cytotoxicity test in vitro and implantation test in vivo, [ Methods] In accordance with ISO and GB/T of China, we cultured L929 cells and adopted MTr to test the cytotoxicity of PDS. Also we detected the degradation process of PDS materials by implanted in rabbits, [ Results] There were no obvious morphological changes of cultured cells attachment on the surface of the composite materials, and the growth and proliferation of the cultured cells could not be inhibited by the tested biomaterials, The degradation of PDS material accelerated around 12 weeks and it had been completely absorbed in 24 weeks. There was neither hyperplasia or necrosis nor other rejection reaction after the materials were implanted, [ Conclusion] The bioabsorbable external stent made of polydioxanone has well biocompatibility, and can be saftly used in clinical studies.