生物可降解人工胸壁的生物相容性与体内降解研究  

RESEARCH ON BIOCOMPATIBILITY AND IN VIVO DEGRADATION OF BIODEGRADABLE CHEST WALL PROSTHESIS MATERIALS IN EXPERIMENTAL ANIMALS

作　　者：龚志云[1] 徐志飞[1] 秦雄[1] 赵学维[1] 王文祖[2] 

机构地区：[1]第二军医大学附属长征医院胸心外科,上海200003 [2]东华大学生物医用纺织品研究中心

出　　处：《中国修复重建外科杂志》2007年第8期867-871,共5页Chinese Journal of Reparative and Reconstructive Surgery

基　　金：国家自然科学基金资助项目(30571847)~~

摘　　要：目的对制备的人工胸壁材料的生物相容性及体内降解情况进行研究,为其应用于临床提供实验依据。方法参照医疗器械生物学评价标准和要求,对人工胸壁组分材料聚对二氧环己酮(A)、壳聚糖(B)、羟基磷灰石/胶原海绵(C)进行评价。溶血实验另设生理盐水为阴性对照组,蒸馏水为阳性对照组,各组取样本5个加抗凝兔血0.2ml,取上清测吸光度(A)值并计算溶血率。取20只小鼠行急性全身毒性实验,每组5只,分为A、B、C和阴性对照组;阴性对照注入生理盐水,A、B、C组由尾静脉注入A、B、C材料浸提液,50ml/kg,于24、48、72h时观察。热源实验取12只大白兔,每组3只,分为A、B、C组和阴性对照组(注入生理盐水),自耳静脉分别注射A、B、C材料浸提液,10ml/kg后,每隔1h测肛温1次,共3次,观察动物的体温变化,并计算各兔体温的升高度数和升高总数。体内植入及降解实验取12只大白兔,将A、B、C材料(制成10mm×10mm大小)分别植入背部肌肉内,于2、4、8、12、16、24周各时间点处死2只,行大体观察,组织学、材料降解及组织相容性观察。结果人工胸壁各组分材料的溶血率均小于国家规定的5%标准,在体外不引起溶血反应;与阴性对照组比较无统计学意义(P>0.05);不引起全身毒性反应,各材料注入后,A、B、C组动物均无死亡,活动进食正常。热源实验各组动物体温升高值均在0.6℃以下,且每组3只兔体温升高值的总数<1.4℃,无致热作用;各材料植入体内初期有轻度炎性反应,随植入时间延长逐步减轻;组分材料分期降解吸收,降解过程中未见组织变性、坏死和异常增生。结论人工胸壁各组分材料具有良好的生物相容性和适宜的降解性能,具有临床开发应用前景。Objeetive To evaluate the biocompatibility and in vivo degradation of novel chest wall prosthesis materials and provide some data for their clinical application. Methods According to the standard for the biological evaluation of the medical devices, several tests were performed to evaluate the tissue toxic effects induced by polydioxanone （Group A）, chitosan （Group B）, and hydroxyapitite/collagen （Group C）, which were tested as component materials of the chest wall prosthesis. In the hemolysis test, 0. 2 ml of the anticoagulant rabbit blood was added to the component materials and the normal saline （negative control） and to the distilled water （positive control）. Five samples were made in each group. Absorbency was measured and the hemolysis rate was determined. In the acute systemic toxicity test, 20 mice were randomly divided into 4 groups （Groups A, B and C, and the normal saline group, n=5）. The leaching liquid （50 ml/kg） was injected through the caudal vein, which was observed at 24, 48 and 72 hours. In the pyrogen test, 12 rabbits were randomly divided into 4 groups （Groups A, B, C and the normal saline group, n= 3） the leaching liquid（10 ml/kg） was injected through the ear vein, and the body temperature was recorded within 3 hours. In the in vivo degradable test, the component materials （10 mm× 10 mm） were implanted in 12 rabbits at 2, 4, 8, 12, 16 and 24 weeks, respectively, after operation. Two rabbits were sacrificed for the macroscopic and the microscopic examinations. Results The chest wall component materials had no hemolytic reaction, no acute systemic toxicity, and no pyrogen reaction. The results demonstrated that the implanted materials had only a mild inflammatory reaction during the early days of the grafting, which subsided gradually. There was no tissue denaturation, necrosis or pathological hyperplasia when the prosthesis materials were degraded. Conelusion The degradable materials of the chest wall prosthesis have a good biocompatibility and a great

关 键 词：组织工程 人工胸壁 生物可降解材料 生物相容性 

分 类 号：R318.1[医药卫生—生物医学工程] R318.08[医药卫生—基础医学]