标题：Biocompatibility of a New Kind of Polyvinyl Alcohol Embolic Microspheres: In Vitro and In Vivo Evaluation
作者：Sun, Xiangyang; Dai, Haixue; Guo, Ping; Sha, Xianyi
作者机构：[Sun, Xiangyang] Shandong Univ, Qilu Hosp, Dept Intervent Radiol, Jinan, Shandong, Peoples R China.; [Dai, Haixue; Guo, Ping] Jiangsu Hengrui Med Co 更多
通讯作者：Sha, XY;Sha, XY;Sha, Xianyi
通讯作者地址：[Sha, XY]Fudan Univ, Inst Integrat Med, 826 Zhangheng Rd, Shanghai, Peoples R China;[Sha, XY]Fudan Univ, Sch Pharm, 826 Zhangheng Rd, Shanghai, People 更多
关键词：Microspheres; Biocompatibility; Polyvinyl alcohol; Embolization
摘要：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 (1g microspheres with 7mL 0.9% sodium chloride (SC) per vial, size: 500-700 mu m) and blue microspheres (2g microspheres with 7mL 0.9% SC per vial, size: 500-700 mu m) 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. 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.