Department of Urogynaecology, Imperial College London, London, UK.
Int Urogynecol J. 2024 Apr;35(4):741-758. doi: 10.1007/s00192-024-05741-3. Epub 2024 Feb 15.
Polypropylene (PP) mesh for the treatment of pelvic organ prolapse (POP) has raised substantial concerns over long-term complications, leading to its ban in multiple countries. In response, emerging materials are being explored as alternatives for prolapse surgery. Preclinical animal models have historically played a pivotal role in validating medical devices, prior to clinical trials. Successful translation of these materials necessitates the identification of suitable animal models that replicate the female human pelvis and its biomechanical properties. Preclinical in vivo testing assesses the safety of surgical mesh and treatment efficacy in preventing POP recurrence.
The research critically reviews animal models used for preclinical pelvic mesh testing over the last decade and proposes a promising model for future preclinical studies.
Rats were the most common mammal used for toxicity and biocompatibility investigations through abdominal implantation. Although non-human primates serve as a gold standard for efficacy testing, ethical considerations limit their use owing to their close biological and cognitive resemblance to humans. Consequently, sheep were the most preferred large animal model owing to their reproductive system similarities and propensity for spontaneous POP following parity.
The study contributes valuable insights into the selection of appropriate animal models for preclinical pelvic mesh testing, offering guidance that is crucial for enhancing the safety and efficacy of novel surgical interventions in the treatment of POP.
用于治疗盆腔器官脱垂（POP）的聚丙烯（PP）网片引发了人们对长期并发症的极大关注，导致其在多个国家被禁用。为应对这一情况，人们正在探索新兴材料作为脱垂手术的替代方案。在临床试验之前，临床前动物模型在验证医疗器械方面发挥了关键作用。要成功转化这些材料，需要确定合适的动物模型，以复制女性人体骨盆及其生物力学特性。临床前体内测试评估手术网片的安全性以及预防 POP 复发的治疗效果。
本研究对过去十年中用于临床前骨盆网片测试的动物模型进行了批判性回顾，并为未来的临床前研究提出了一种有前途的模型。
大鼠是最常用于腹部植入毒性和生物相容性研究的哺乳动物。尽管非人类灵长类动物是疗效测试的黄金标准，但由于它们与人类在生物学和认知上的密切相似性，道德因素限制了它们的使用。因此，绵羊是最受欢迎的大动物模型，因为它们的生殖系统相似，并且在产仔后容易发生自发性 POP。
本研究为临床前骨盆网片测试中合适动物模型的选择提供了有价值的见解，为提高新型手术干预治疗 POP 的安全性和疗效提供了关键指导。
