体内埋植实验比较全氟丙氧基聚四氟乙烯与传统硅胶的生物相容性

Biocompatibility of perfluoro(propoxy-polytetrafluoroethylene) versus traditional gel silica after implantation in vivo

目的:通过动物埋植实验评估新型生物植入材料全氟丙氧基聚四氟乙烯的生物相容性。方法:实验于2004-09/2006-04在上海交大化学化工学院和上海交大附属第一人民医院耳鼻喉头颈外科实验室完成。①实验材料:采用四氟乙烯、六氟丙烷等原料在反应瓮中以一定的温度和压力,用特定的催化剂合成全氟丙氧基聚四氟乙烯(Mr105～107),半透明状,质地与硅胶类似。用临床目前常用的隆鼻硅胶假体商品作为对照。②实验分组:取健康杂种豚鼠30只,按随机数字表法编号后将消毒后的全氟丙氧基聚四氟乙烯和硅胶模块分别置入左右后腿浅筋膜与肌肉层之间。植入全氟丙氧基聚四氟乙烯材料为新材料组,植入硅胶材料为硅胶组。为防止系统误差,编号为单数的豚鼠左后腿放置新材料,右后腿放硅胶;编号为双数的豚鼠左后腿放置硅胶,右后腿放新材料。完成手术后继续饲养豚鼠,1～10,11～20,21～30号豚鼠分别于术后15,30,60d麻醉后处死,取出埋植模块周围组织,苏木精-伊红染色。实验评估:光镜下观察埋入材料周围组织、细胞的反应和变化,判断两种材料的生物相容性差异。结果:所有豚鼠安全经受了手术,术后未出现感染,也未使用抗生素。25号豚鼠右腿出现排异反应,术后10d埋藏的硅胶排出,排出后切口自然愈合。所有豚鼠切口正常愈合。①植入后15d,两种材料周围均见大量中性粒细胞浸润,并伴有明显血管充血,材料周围无囊壁形成。②植入30d时,材料周围无明显囊壁形成,周围见大量中性粒细胞。硅胶组中发现周边组织明显渗血。③植入60d时,新材料组囊壁厚度明显薄于硅胶组[分别为(35.01±14.03),(66.63±17.96)μm],差异有显著性意义(t=6.849,P<0.01)。结论:全氟丙氧基聚四氟乙烯材料的生物相容性优于传统硅胶材料。

AIM： To evaluate the biocompatibUity of perfluoro （ propoxy-poltetrafluoroethylene） as a novel biological implanting material by animal embedding experiment. METHODS： The experiment was conducted in the School of Chemistry and Chemical Engineering and Department of Otolaryngology and Neck Surgery, First People＇s Hospital, Shanghai Jiao Tong University from September 2004 and April 2006. （1） Perfluoro （propoxy-polytetrafluoroethylene） was prepared by reacting tetafluoroethylene with hexafluorinepropane in a constant temperature and pressure with certain catalyst. The Mt of the resultant polymer was 10^5-10^7, and with translucence similar to gel silica. Meanwhile, the gel silica prothesis widely used in nose augmentation was adopted as control. （2）Thirty healthy guinea pigs were selected and numbered randomly to put the polymer and silica module between the skin and superficial fascia of left and right hind legs, which served as polymer group and gel silica group. To prevent systematic error, the polymer was implanted into the left legs of animals numbered in odd and the right legs of animals numbered in dual, and the silica gel into the right ones of odd number animals and left ones of dual number animals. No.1-10, 11-20, and 21-30 guinea pigs were executed under anesthesia on days 15, 30, and 60 after operation respectively. The materials and surrounding tissues were taken out from the animals for HE staining. The reaction and changes of cell and surrounding tissues were observed under light microscope to compare their biocompatibility. RESULTS： None of the animals was infected after operation and no antibiotics were used. The rejection was found in No. 25 guinea pig; the gel silica implanted was rejected from the right leg 10 days after the operation, and then the incision healed itself. All the incisions of the guinea pigs healed naturally after operation. （1）Fifteen days after implantation, there were a great amount of infiltrated heterophUic granulocyteg accompanied by obvious congestion around the materials, but no cyst wall formed. （2）One month later, there were a great amount of infiltrated heterophilic granulocytes but still no cyst wall formed. In the gel silica group, there was obvious capillary hemorrhage iaround tissues. （3）Sixty days later, the cyst wall of the polymer group was much thinner than that of the gel silica group [（35.01±14.03）μm vs. （66.63±17.96） μm, t =6.849, P 〈 0.01]. CONCLUSION： Biocompatibility of perfluore （propoxy-polytetrafluoroethylene） is better than those of traditional gel silica materials.