首页> 中文期刊> 《中国组织工程研究》 >成骨分化与修复调控转录因子Runx2在股骨头坏死组织中的表达:非随机平行对照临床观察试验方案

成骨分化与修复调控转录因子Runx2在股骨头坏死组织中的表达:非随机平行对照临床观察试验方案

         

摘要

背景:股骨头血供中断或受损引起骨细胞及骨髓成分死亡引发股骨头坏死。多种成骨相关因子如 Runt相关转录因子2(Runx2)、骨形态发生蛋白、骨保护素、骨钙素,在其随后修复过程中发挥重要作用。研究发现Runx2基因为成骨分化和骨形成过程中的控制基因,能促进前成骨细胞中各种矿化相关蛋白基因的转录,使其向成骨细胞方向分化,从而在骨修复中起到关键性的作用。  方法/设计:研究在中国医科大学附属盛京医院完成,为回顾性、单中心、非随机平行对照试验。研究纳入拟进行全髋关节置换的15例股骨头坏死患者和15例骨关节炎患者。试验在术中获得的骨组织标本,以股骨头颈组织Runx2 mRNA表达为主要观察指标,以骨形态发生蛋白2、骨形态发生蛋白7、骨保护素mRNA表达,以及骨钙素免疫反应为次要观察指标。试验方案已在ClinicalTrials.gov注册(注册号 NCT02735538),试验方案取得中国医科大学附属盛京医院伦理委员会的书面批准(批准号:2016PS222K),并取得受试者或监护人的书面知情同意。  讨论:股骨头坏死患者股骨头颈组织包括Runx2 mRNA在内的多个骨修复相关基因表达的检测已于2010至2011年完成。研究结果为阐释Runx2 mRNA在股骨头坏死中可能扮演的角色,以及对骨修复重建的意义有所贡献。%BACKGROUND:Osteonecrosis of the femoral head (ONFH) results from an interruption of the blood supply to the femoral head or injury-caused death of chondrocytes and bone marrow components. Many osteogenesis-related factors, such as Runt-related transcription factor 2 (Runx2), bone morphogenetic protein (BMP), osteoprotegerin and osteocalcin, are involved in the subsequent repair process. The Runx2 gene has been shown to control osteoblast differentiation and formation by upregulating the transcription of various mineralization-related protein genes, alowing osteoblast precursors differentiation into osteoblasts, and playing a key role in bone repair. METHODS/DESIGN:This retrospective, single-center, non-randomized, paralel-controled trial was performed at Shengjing Hospital of China Medical University, China. Fifteen patients with ONFH and 15 patients with osteoarthritis undergoing total hip replacement were included. Primary measure was Runx2messenger RNA (mRNA) expression in femoral head and neck tissue, and secondary measures included BMP-2, BMP-7 and osteoprotegerin mRNA expression, as wel as osteocalcin immunoreactivity. This trial was registered at ClinicalTrials.gov (identifier: NCT02735538) and acquired written approval from the Ethics Committee of Shengjing Hospital of China Medical University (approval No. 2016PS222K). Written informed consent was obtained from each included patient. DISCUSSION:This study involved in the detection of mRNA expression of several bone repair-related genes, including Runx2, in the femoral head and neck of patients with ONFH was performed between 2010 and 2011. This observational study wil help clarify the role and possible clinical significance of Runx2 in femoral head necrosis, bone repair and reconstruction.

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