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中华疝和腹壁外科杂志(电子版) ›› 2024, Vol. 18 ›› Issue (02) : 121 -124. doi: 10.3877/cma.j.issn.1674-392X.2024.02.001

疝修补材料专栏

对再生型疝修补补片动物试验设计的考量
程茂波1, 刘钰莎1, 张旭1, 刘文博1,(), 赵鹏1   
  1. 1. 100081 北京,国家药品监督管理局医疗器械技术审评中心
  • 收稿日期:2024-03-01 出版日期:2024-04-18
  • 通信作者: 刘文博
  • 基金资助:
    国家重点研发计划"组织工程类医疗器械产品安全性有效性评价技术研究"项目(2022YFC2409800); 其中的"软组织缺损修复组织工程医疗器械产品评价技术研究"课题(2022YFC2409801)

Consideration for animal studies design of hernia mesh for tissue regeneration

Maobo Cheng1, Yusha Liu1, Xu Zhang1, Wenbo Liu1,(), Peng Zhao1   

  1. 1. Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China
  • Received:2024-03-01 Published:2024-04-18
  • Corresponding author: Wenbo Liu
引用本文:

程茂波, 刘钰莎, 张旭, 刘文博, 赵鹏. 对再生型疝修补补片动物试验设计的考量[J]. 中华疝和腹壁外科杂志(电子版), 2024, 18(02): 121-124.

Maobo Cheng, Yusha Liu, Xu Zhang, Wenbo Liu, Peng Zhao. Consideration for animal studies design of hernia mesh for tissue regeneration[J]. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 2024, 18(02): 121-124.

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.

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[1] 刘文博, 史新立, 赵鹏, 邢丽娜, 张书培, 汤菊莉, 黄长瑾. 疝修补补片类医疗器械的临床试验设计考量[J]. 中华疝和腹壁外科杂志(电子版), 2020, 14(04): 327-330.
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