在为脱垂手术引入新的生物材料之前,需要对宿主反应进行动物研究。不幸的是,研究设计的巨大差异阻碍了获得安全性和有效性的概述,并转化为临床实践。我们的目的是系统地回顾有关动物研究中描述宿主反应的所有结果指标的文献,以评估用于脱垂手术的泌尿外科外科网状植入物的生物相容性。此外,通过荟萃分析,我们旨在评估植入的效果,并将其与接受假手术或天然组织修复的对照动物进行比较.
我们从成立之初到2020年8月进行了系统的搜索。由于这是一项探索性研究,我们包括原创,控制,和描述任何宿主对植入物反应的非对照动物研究。在≥2篇文章中报告≥10次的定量结果指标符合荟萃分析的条件。
50篇文章被纳入定性综合,36篇文章符合荟萃分析的条件。总的来说,154个结局指标被定义并分类为(1)组织形态学,(2)生物力学和,(3)宏观形态。有阴道植入物的动物表现出显著增加的M1和M2巨噬细胞,MMP-2,新生血管,TNF-α,和刚度,与对照动物相比,阴道收缩力较低。
与对照动物相比,阴道网状物植入后动物的宿主反应显着不同,促炎和抗炎。然而,我们观察到报告结局的一致性不足.对于未来的动物研究,我们建议开发一套核心成果,理想地预测女性的宿主反应。
Before the introduction of new biomaterials for prolapse surgery, animal studies on the host response are required. Unfortunately, large variation in study design hampers obtaining an overview of the safety and efficacy, and translation to clinical practice. Our aim is to systematically
review the literature on all outcome measures describing the host response in animal studies assessing the biocompatibility of urogynecologic surgical mesh implants for prolapse surgery. Furthermore, by meta-analysis, we aim to assess the effect of implantation and compare this to control animals receiving sham surgery or native tissue repair.
We performed a systematic search from inception to August 2020. Since this is an explorative study we included original, controlled, and noncontrolled animal studies describing any host response to the implant. Quantitative outcome measures reported ≥10 times in ≥2 articles were eligible for meta-analysis.
Fifty articles were included in the qualitative synthesis and 36 articles were eligible for meta-analysis. In total, 154 outcome measures were defined and classified into (1) histomorphology, (2) biomechanics and, (3) macroscopic morphology. Animals with vaginal implants demonstrated significantly increased M1 and M2 macrophages, MMP-2, neovascularization, TNF-α, and stiffness, and lower vaginal contractility compared to control animals.
The host response significantly differs in animals after vaginal mesh implantation compared to control animals, both pro- and anti-inflammatory. However, we observed a paucity in the uniformity of reported outcomes. For future animal studies, we propose the development of a core outcome set, which ideally predicts the host response in women.