中国高原地区老年男性退行性骨质疏松患者氧化应激相关因子和骨代谢指标的相关性:非随机对照临床试验方案
发布时间：2018-11-08 09:32
【摘要】：背景:低氧是影响和调节骨生长代谢的重要因素,因此高原低氧地区老年人骨质疏松患者较多。与氧化应激有关的低氧诱导因子可诱导血管内皮生长因子、胰岛素样生长因子及内皮素等多种因子表达异常,但是否能影响骨代谢指标的变化尚不清楚。目的:试验探讨高原地区老年男性退行性骨质疏松患者氧化应激相关因子和骨代谢指标的相关性。方法:试验为前瞻性,单中心,非随机,对照临床试验方案。试验计划纳入中国青海大学附属医院中国高原低氧地区老年退行性骨质疏松患者120例设为骨质疏松组,同时收集120位健康老年人作为对照组。于入院后1 d采用酶联免疫吸附法检测两组血清氧化应激相关因子低氧诱导因子1α,2α,血管内皮生长因子、骨钙素及抗酒石酸酸性磷酸酶5 b水平变化,采用双能X射线骨密度仪检测L_(1-4)椎体、右侧股骨颈和股骨大转子共3个区域的骨密度变化。试验的主要观察指标为入院后1 d血清低氧诱导因子1α水平变化;次要观察指标为入院后1 d血清低氧诱导因子2α,血管内皮生长因子及骨钙素及抗酒石酸酸性磷酸酶5 b水平变化;入院后1 d氧化应激指标低氧诱导因子1α,2α,血管内皮生长因子和骨代谢指标骨钙素及抗酒石酸酸性磷酸酶5 b水平的相关性。试验经青海大学附属医院伦理委员会批准[审批单位:青海大学附属医院,审批号:QHY1402G]。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者本人对试验方案和过程均知情同意,并签署知情同意书。试验于2015年1月开始进行患者招募,样本及数据收集时间为2015年1月至2018年2月,结果指标分析时间及试验完成时间为2018年3月。文章结果将以科学会议报告,或在同行评议的期刊上发表传播。试验已在中国临床试验注册中心注册(注册号:Chi CTR-ROC-17012848)。讨论:文章希望通过此试验证实高原地区老年男性退行性骨质疏松患者氧化应激相关因子和骨代谢指标具有相关性,以进一步明确高原地区老年男性退行性骨质疏松的发病危险因素,从而为该地区人群骨质疏松发生及发展的预防提供帮助。
[Abstract]:Background: hypoxia is an important factor affecting and regulating bone growth and metabolism. Hypoxia inducible factors associated with oxidative stress can induce abnormal expression of vascular endothelial growth factor, insulin-like growth factor and endothelin, etc. Objective: to investigate the correlation between oxidative stress related factors and bone metabolism in elderly men with degenerative osteoporosis at high altitude. Methods: the trial was prospective, single center, non-randomized, controlled clinical trial. 120 elderly patients with degenerative osteoporosis were selected as osteoporosis group and 120 healthy elderly as control group. The serum levels of hypoxia inducible factor 1 伪, 2 伪, vascular endothelial growth factor, osteocalcin and tartrate resistant acid phosphatase 5b were measured by enzyme linked immunosorbent assay (Elisa) on day 1 after admission. Bone mineral density (BMD) of L1-4 vertebrae, right femoral neck and femoral trochanter were measured by dual energy X-ray absorptiometry. The main outcome measures of the experiment were the changes of serum hypoxia inducible factor-1 伪 (HIF-1 伪) on the 1st day after admission. The changes of serum hypoxia inducible factor 2 伪, vascular endothelial growth factor, osteocalcin and tartrate-resistant acid phosphatase 5b were observed 1 day after admission. 1 day after admission, the levels of hypoxia inducible factor 1 伪, 2 伪, vascular endothelial growth factor, bone metabolism index osteocalcin and tartrate-resistant acid phosphatase 5b were correlated. The test was approved by the Ethics Committee of affiliated Hospital of Qinghai University [examination and approval Unit: affiliated Hospital of Qinghai University, approval number: QHY1402G]. The study meets the requirements of the Helsinki Declaration formulated by the World Medical Association. Participants themselves have informed consent and signed informed consent to the trial program and process. Patient recruitment began in January 2015. The time of sample and data collection was from January 2015 to February 2018. The time of analysis of the results and the time of completion of the trial were March 2018. The results will be published in scientific conference reports or in peer-reviewed journals. The trial has been registered with the China Clinical trial Registry (Registration No.: Chi CTR-ROC-17012848). Discussion: this paper hopes to prove the correlation between the factors related to oxidative stress and bone metabolism in elderly male patients with degenerative osteoporosis at high altitude. In order to further clarify the risk factors of degenerative osteoporosis in elderly men in plateau area, so as to provide help for the prevention of the occurrence and development of osteoporosis in the population in this area.
【作者单位】： 青海大学附属医院创伤骨病科;青海省预备役旅医院骨科;
【分类号】：R580
，
本文编号：2318082
[Abstract]:Background: hypoxia is an important factor affecting and regulating bone growth and metabolism. Hypoxia inducible factors associated with oxidative stress can induce abnormal expression of vascular endothelial growth factor, insulin-like growth factor and endothelin, etc. Objective: to investigate the correlation between oxidative stress related factors and bone metabolism in elderly men with degenerative osteoporosis at high altitude. Methods: the trial was prospective, single center, non-randomized, controlled clinical trial. 120 elderly patients with degenerative osteoporosis were selected as osteoporosis group and 120 healthy elderly as control group. The serum levels of hypoxia inducible factor 1 伪, 2 伪, vascular endothelial growth factor, osteocalcin and tartrate resistant acid phosphatase 5b were measured by enzyme linked immunosorbent assay (Elisa) on day 1 after admission. Bone mineral density (BMD) of L1-4 vertebrae, right femoral neck and femoral trochanter were measured by dual energy X-ray absorptiometry. The main outcome measures of the experiment were the changes of serum hypoxia inducible factor-1 伪 (HIF-1 伪) on the 1st day after admission. The changes of serum hypoxia inducible factor 2 伪, vascular endothelial growth factor, osteocalcin and tartrate-resistant acid phosphatase 5b were observed 1 day after admission. 1 day after admission, the levels of hypoxia inducible factor 1 伪, 2 伪, vascular endothelial growth factor, bone metabolism index osteocalcin and tartrate-resistant acid phosphatase 5b were correlated. The test was approved by the Ethics Committee of affiliated Hospital of Qinghai University [examination and approval Unit: affiliated Hospital of Qinghai University, approval number: QHY1402G]. The study meets the requirements of the Helsinki Declaration formulated by the World Medical Association. Participants themselves have informed consent and signed informed consent to the trial program and process. Patient recruitment began in January 2015. The time of sample and data collection was from January 2015 to February 2018. The time of analysis of the results and the time of completion of the trial were March 2018. The results will be published in scientific conference reports or in peer-reviewed journals. The trial has been registered with the China Clinical trial Registry (Registration No.: Chi CTR-ROC-17012848). Discussion: this paper hopes to prove the correlation between the factors related to oxidative stress and bone metabolism in elderly male patients with degenerative osteoporosis at high altitude. In order to further clarify the risk factors of degenerative osteoporosis in elderly men in plateau area, so as to provide help for the prevention of the occurrence and development of osteoporosis in the population in this area.
【作者单位】： 青海大学附属医院创伤骨病科;青海省预备役旅医院骨科;
【分类号】：R580
，
本文编号：2318082
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