盆底重建手术国产原创新型网片研发的实验研究

Implantation of unabsorbable mesh in the vagina for the treatment of pelvic organ prolapse is proved to be effective by evidence-based medicine currently . However, it could induce high rate of postoperative complications, which are difficult to deal with. On this scenario, we have urgent need for biomaterials which have superior biocompatibility and excellent biomechanical properties and it has became an advanced research hotspot. Domestic original mesh- bacterial cellulose is a new type of biomaterial, which has much more sources of raw material and low cost. Bacterial cellulose has been used for artificial skin tissue and blood vessels because of superior biocompatibility and excellent biomechanical properties. The anatomy of ewe’s vagina of is similar to human’s, so our study will apply ewe as animal model. We will observe the difference of histomorphology, host response on the molecular level and biomechanical properties after implantation of two kinds of mesh in the vagina of ewe, the domestic original bacterial cellulose mesh and the most common PP mesh at different time points. Furthermore, we will identify if canonical Wnt pathway modulates the formation of extracellular matrix, in order to explain the mechanism of superior biocompatibility and excellent biomechanical properties of the new bacterial cellulose mesh from macroscopic level to molecular level. At the same time, we will identify if the new mesh can reduce the rate of postoperative complications caused by “foreign body reaction” and and provide basic data for the use of new mesh in the pelvic reconstructive surgery.

循证A级证据表明植入不可吸收网片是治疗盆腔器官脱垂有效方法，但植入阴道网片并发症是难以解决。研发更好组织相容性并且具有良好生物力特征的新型盆底植入材料，这也是目前国际研究热点和临床亟待解决的关键问题。国产原创新型网片-细菌纤维素（BC）是一种新型生物材料，原材料来源广泛并价廉，因其良好组织相容性和生物力学特征已被应用为人工皮肤及人工血管的材料。本研究拟用与人阴道相似的绵羊作为大动物模型，分别植入国产原创新型细菌纤维素网片与目前国际临床最常使用的聚丙烯网片后，观察不同时段组织形态学差异、机体反应分子水平的变化、生物力学差异以及经典Wnt信号通路调控细胞外基质成分机制，从而在大体至分子水平全面明确新型网片植入阴道后的组织相容性及力学特性的机制，同时明确新型网片是否可有效降低“异物反应”的并发症，探究新型网片与聚丙烯网片对阴道功能及解剖恢复的差别，为新型网片在盆底重建手术中的应用提供理论基础。

循证A级证据表明植入不可吸收网片是治疗盆腔器官脱垂有效方法，但植入阴道网片并发症是难以解决。研发更好组织相容性并且具有良好生物力特征的新型盆底植入材料，这也是目前国际研究热点和临床亟待解决的关键问题。国产原创新型网片-细菌纤维素（BC）是一种新型生物材料，原材料来源广泛并价廉，因其良好组织相容性和生物力学特征已被应用为人工皮肤及人工血管的材料。本研究选用与人阴道相似的绵羊作为大动物模型，分别植入国产原创新型细菌纤维素网片与目前国际临床最常使用的聚丙烯网片后，观察植入后1周和12周后网片暴露情况、组织形态学差异、胶原生成情况以及生物力学差异。研究表明植入后在阴道局部组织引起的炎症反应较重，作为候选材料在应用于盆底重建领域之前，还需进一步改善制作工艺及参数，以满足盆底重建特殊需求。也因此我们进一步评估了轻型钛化物聚丙烯网片的应用潜能，其植入后在阴道局部组织引起的炎症反应较轻、引起的周围纤维化程度较轻，能够达到盆底生物力学要求；轻型钛化物聚丙烯网片能够起到优化作用，是具有应用前景的盆底修复产品。