对再生型疝修补补片动物试验设计的考量

Consideration for animal studies design of hernia mesh for tissue regeneration

再生型疝修补补片作为一种理想的疝和腹壁缺损修复医疗器械,对再生修复功效的评价是该类补片安全性和有效性的核心关键,与患者的疝复发直接相关。动物试验是疝修补补片再生功效评价的重要方法之一。结合多项已上市再生型疝补片动物研究及相关文献报道,本文对该类器械动物试验设计的各个要素进行了初步探讨并给出相关建议,供再生型疝修复生物材料的研发人员、动物试验研究人员、普通外科临床医生参考。

Hernia mesh for tissue regeneration is a prospective medical device for repairing hernia and abdominal wall defects.The evaluation of regenerative repair efficacy plays an important role for the safety and effectiveness of hernia mesh for tissue regeneration,which is directly related to the recurrence of hernia in patients.Animal study is one of the important methods to validate the regeneration efficacy of hernia mesh.Combined with several animal studies on these devices and related literature reports,this paper discusses various elements of animal studies design and gives relevant suggestions for research and development personnel,animal study researchers,and general surgery clinicians of regenerative hernia repair biomaterials.