the aim of this study is to investigate the biocompatibility of polyvinyl alcohol (pva) embolic microspheres by in vivo and in vitro evaluations.
two specifications of pva microspheres including colorless microspheres (1 g microspheres with 7 ml 0.9% sodium chloride (sc) per vial, size: 500–700 μm) and blue microspheres (2 g microspheres with 7 ml 0.9% sc pervial, size: 500–700 μm) were assessed for biocompatibility. the vitro cytotoxicity was evaluated in l929 cells by mtt assay. acute systemic toxicity and 28-repeat dose intravenous subchronic toxicity were assessed in 20 icr mice and 40 sd rates,respectively. skin sensitization was conducted in 30 adult albino guinea pigs by maximization test, in addition, intracutaneous reaction test was performed in new zealand white rabbits. hemolysis ratio of pva microspheres was evaluated with rabbit blood. moreover, test for genotoxicity was assessed by bacterial reverse mutation test and mouse lymphoma mutagenesis assay.
共有两种规格的pva微球，无色微球(1 g微球和7 ml 0.9%氯化钠(sc) /瓶，大小: 500–700 μm)和蓝色微球(2 g微球和7 ml 0.9% sc/瓶，大小：500–700 μm)进行生物相容性评估。采用mtt法，在l929细胞中评价体外细胞毒性。分别对20只icr小鼠和40只sd大鼠进行急性全身毒性和28次重复剂量的静脉亚慢性毒性评估。按最大值试验对30只成年白化豚鼠进行皮肤致敏试验，对新西兰大白兔进行皮内反应试验。用家兔血测定pva微球的溶血率。此外，通过细菌回复突变试验和小鼠淋巴瘤细胞突变试验评估遗传毒性。
no cytotoxicity, hemolysis, or acute toxicity of pva microspheres was found, and slight fluctuations of biochemical indexes were observed in test of 28-day repeat dose intravenous subchronic toxicity, while these changes remained within our historical permitted range. maximization test and intracutaneous reactivity test disclosed no irritation to skin or tissues. according to bacterial reverse mutation test and mouse lymphoma mutagenesis assay, no genotoxicity of pva microspheres was observed.
pva microspheres showed excellent biocompatibility both in vivo and in vitro, and they were promising embolic materials for drug-eluting beads transarterial chemoembolization (deb-tace) therapy.
pva微球在体内和体外均具有良好的生物相容性，是进行载药微球经动脉化疗栓塞(deb - tace)治疗的理想栓塞材料。