三种植入方法评价内置疝修补补片动物试验研究的比较

Comparison of Three Implantation Methods in Evaluating the Experimental Study of Internal Hernia Patch in Animals

目的疝修补补片置入腹腔后发生粘连的可能性及程度是评价产品安全性的重要因素。本研究目的为在动物试验中确定合适的动物模型、适宜的植入方法及观察方式。方法将6头实验用小型猪(雌性未孕,体重30～40 kg)随机分为A、B、C三组(A组为腹腔镜式腹膜前直接植入组,B组为开放式手术腹壁全层缺损植入组,C组为腹壁疝模型腹腔镜植入组),每组2头。植入补片4周后,用腹腔镜进行观察补片是否引起腹腔内组织器官粘连。结果 A组植入操作简单,在评价补片的有效性的同时能够单一考虑补片的安全性因素,腹腔镜观察没有引起腹腔内组织器官粘连;B组开放式植入对外界环境要求较高,C组耗时较长,并存在造模不成功的风险,B、C两组均引起腹腔内组织器官的粘连。结论评价内置疝修补补片的动物试验研究时,宜采用腹腔镜式腹膜前直接植入的方法进行评价。

Objective The possibility and extent of adhesion after herniorrhaphy patch placement in abdominal cavity is an important factor to evaluate the safety of the product.The purpose of this study is to determine the appropriate animal model,implantation methods and observation methods in animal experiments.Methods Six experimental miniature pigs(none pregnant females,weighing 30-40 kg)were randomly divided into three groups:group A,B and C,with 2 in each group.Group A:laparoscopic direct peritoneal implantation;Group B:open operation for full-thickness defect of abdominal wall;Group C:laparoscopic implantation of abdominal wall hernia model.Four weeks after implantation,laparoscopy was used to observe whether the patch caused intraperitoneal tissue and organ adhesion.Results In group A,the procedure of implantation was simple,and the safety factors of the patch could be considered only while evaluating the effectiveness of the patch.Laparoscopic observation did not cause intraperitoneal tissue and organ adhesion.Open implantation in Group B requires higher external environment.Group C is timeconsuming and at risk of unsuccessful modeling.The adhesion of tissues and organs in abdominal cavity was induced in group B and C.Conclusion In the evaluation of the animal experimental study of internal herniorrhaphy patch,the method of direct retroperitoneal implantation should be used for evaluation.