APANK-Study: Application of autogenous platelet-rich fibrin membranes in the treatment of antiresorptive-associated necrosis of the jaw - a multicenter observational study

APNK 研究：自体富血小板纤维蛋白膜在治疗抗吸收性颌骨坏死中的应用——一项多中心观察性研究

• 批准号: 427823193
• 负责人: Dr. Sebastian Blatt
• 金额: --
• 依托单位: Klinik für Mund-, Kiefer- und Gesichtschirurgie - Plastische Operationen
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2019
• 资助国家: 德国
• 起止时间: 2018-12-31 至 2021-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/427823193?language=en
• 关键词: APANK; Study; Application; autogenous; platelet

Synthetic analoga of pyrophosphat (bisphosphonates), monoclonal Receptor Activator of Nuclear Factor Kappa b Ligand (RANKL)-antibodies or anti-angiogenetic antibodies are used in the therapy of progressed breast and prostate cancer, or multiple myeloma. Since the first description by Marx et al. in 2003, medication-related osteonecrosis of the jaw (MRONJ) is a severe complication of the antiresorptive therapy, which can lead to partial or complete loss of parts of the jaw. The guideline-compatible therapy consists in the surgical removal of the necrotic bone as well as the achievement of a tension-free and saliva-tight wound closure. Despite compliance with all criteria, surgical therapy is associated with a significant rate of postoperative wound healing disorders and therapy failure. It may result in early wound dehiscence with exposed bone or delayed complications may occur weeks or months after the therapy has been carried out. The pathophysiology of complications is not fully understood, it seems than various factors of wound healing are affected (collagen synthesis, collagen crosslinking, angiogenesis, proliferation of fibroblasts). The additional application of autogenous products, such as the platelet rich fibrin (PRF) membrane, could appear useful as an additive agent in the surgical therapy of MRONJ, as it contains a high concentration of growth factors and matrix components.The aim of the proposed multicenter study is to observe the reduction of post-surgical wound healing complication by application of autogenous PRF-membranes. It is envisaged to include 23 patients per center (n = 46) for a total duration of 12 months. The primary outcome is clinical success (completed wound healing without bone exposure after 6 weeks), which will be determined using two different wound healing scores. The hypothesis is that the additional application of PRF-membranes in the treatment of MRONJ leads to better wound healing within the first six weeks. This pilot study is supposed to gain the prerequisites to subsequently conduct a randomized controlled intervention study that will proof the effectiveness of PRF-membranes in the treatment of medication-related osteonecrosis of the jaw.

焦磷酸盐（二膦酸盐）的合成类似物、核因子κ B配体（RANKL）的单克隆受体激活剂抗体或抗血管生成抗体用于治疗进展性乳腺癌和前列腺癌或多发性骨髓瘤。自2003年马克思等人首次描述以来，药物相关性颌骨骨坏死（MRONJ）是抗吸收治疗的一种严重并发症，可导致部分颌骨部分或完全丧失。符合指南的治疗包括手术切除坏死骨以及实现无张力和唾液密封的伤口闭合。尽管符合所有标准，但手术治疗与术后伤口愈合障碍和治疗失败率显著相关。它可能导致早期伤口裂开，骨暴露，或在治疗后数周或数月发生延迟并发症。并发症的病理生理学尚未完全了解，似乎伤口愈合的各种因素都受到影响（胶原合成、胶原交联、血管生成、成纤维细胞增殖）。额外应用自体产品，例如富血小板纤维蛋白（PRF）膜，可能会在MRONJ的手术治疗中用作添加剂，因为它含有高浓度的生长因子和基质成分。拟议的多中心研究的目的是观察通过应用自体PRF膜减少手术后伤口愈合并发症。预计每个中心纳入23例患者（n = 46），总持续时间为12个月。主要结局是临床成功（6周后伤口完全愈合，无骨暴露），将使用两种不同的伤口愈合评分确定。假设是在MRONJ治疗中额外应用PRF膜导致前六周内伤口愈合更好。这项初步研究旨在为随后进行随机对照干预研究提供先决条件，该研究将证明PRF膜在治疗药物相关颌骨骨坏死中的有效性。