PDS血管外支架体外毒性和体内相容性的实验研究.pdfVIP

山东医药2007年第47卷第36期 PDS血管外支架体外毒性和体内 相容性的实验研究 游庆军 ，段 亮 ，肖明第 ，杜晓东 ，王 峰 ，蒋锡初 (1苏州大学附属第四医院，江苏无锡214062；2上海交通大学附属第一人民医院) [摘要] 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、MTr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支架材料元细胞毒性，组织反应轻，可满足体内植入的要求。 [关键词] 聚对二氧环己酮；细胞毒性；生物相容性；血管外支架 [中图分类号] R654．2 [文献标识码] A [文章编号] 1002-266X(2007)36-O019-03 Biocompatibility and biological safety of the external stent material polydioxanone in vitroin vivo study YOU Qing-jun，DUAN Liang，XIAO Ming—di，DU Xiao—do ，WANG Fe ，JIANG Xi—chu ( e Fourth Affiliated Hospital ofSuzhou University， 214062 P．R．China) Abstract：[Objective]To evaluate the biocompatibility and biological s ty of the external stent material polydiox— anone(PDS)by cytotoxicity test in vitro and implantation test in vivo、 [Methods]In accordance with ISO and GB／T of China，we cultured L929 ceils 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 cult~ed 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陀jection reaction after the materials were implanted、[Con- clusion]The bioabsorbable external stent made of polydioxanone has well biocompatibility，and Can be saffly used in clini- cal stu出es． Key words：polydioxanone；biocompatibility；cytotoxicity；external stent 聚对二氧环己酮(PDS)可吸收缝线是一种单丝 物医用纺织品研究中心。将PDS网裁剪成10 mm× 型可吸收缝合线，组织反应极小，无毒，无致畸作用， 10 rflnl大小试件，环氧乙烷消毒后放人4℃冰箱中 自身强度大，组