中國(guó)高原地區(qū)老年男性退行性骨質(zhì)疏松患者氧化應(yīng)激相關(guān)因子和骨代謝指標(biāo)的相關(guān)性:非隨機(jī)對(duì)照臨床試驗(yàn)方案
發(fā)布時(shí)間：2018-11-08 09:32
【摘要】：背景:低氧是影響和調(diào)節(jié)骨生長(zhǎng)代謝的重要因素,因此高原低氧地區(qū)老年人骨質(zhì)疏松患者較多。與氧化應(yīng)激有關(guān)的低氧誘導(dǎo)因子可誘導(dǎo)血管內(nèi)皮生長(zhǎng)因子、胰島素樣生長(zhǎng)因子及內(nèi)皮素等多種因子表達(dá)異常,但是否能影響骨代謝指標(biāo)的變化尚不清楚。目的:試驗(yàn)探討高原地區(qū)老年男性退行性骨質(zhì)疏松患者氧化應(yīng)激相關(guān)因子和骨代謝指標(biāo)的相關(guān)性。方法:試驗(yàn)為前瞻性,單中心,非隨機(jī),對(duì)照臨床試驗(yàn)方案。試驗(yàn)計(jì)劃納入中國(guó)青海大學(xué)附屬醫(yī)院中國(guó)高原低氧地區(qū)老年退行性骨質(zhì)疏松患者120例設(shè)為骨質(zhì)疏松組,同時(shí)收集120位健康老年人作為對(duì)照組。于入院后1 d采用酶聯(lián)免疫吸附法檢測(cè)兩組血清氧化應(yīng)激相關(guān)因子低氧誘導(dǎo)因子1α,2α,血管內(nèi)皮生長(zhǎng)因子、骨鈣素及抗酒石酸酸性磷酸酶5 b水平變化,采用雙能X射線骨密度儀檢測(cè)L_(1-4)椎體、右側(cè)股骨頸和股骨大轉(zhuǎn)子共3個(gè)區(qū)域的骨密度變化。試驗(yàn)的主要觀察指標(biāo)為入院后1 d血清低氧誘導(dǎo)因子1α水平變化;次要觀察指標(biāo)為入院后1 d血清低氧誘導(dǎo)因子2α,血管內(nèi)皮生長(zhǎng)因子及骨鈣素及抗酒石酸酸性磷酸酶5 b水平變化;入院后1 d氧化應(yīng)激指標(biāo)低氧誘導(dǎo)因子1α,2α,血管內(nèi)皮生長(zhǎng)因子和骨代謝指標(biāo)骨鈣素及抗酒石酸酸性磷酸酶5 b水平的相關(guān)性。試驗(yàn)經(jīng)青海大學(xué)附屬醫(yī)院倫理委員會(huì)批準(zhǔn)[審批單位:青海大學(xué)附屬醫(yī)院,審批號(hào):QHY1402G]。研究符合世界醫(yī)學(xué)會(huì)制定的《赫爾辛基宣言》的要求。參與者本人對(duì)試驗(yàn)方案和過程均知情同意,并簽署知情同意書。試驗(yàn)于2015年1月開始進(jìn)行患者招募,樣本及數(shù)據(jù)收集時(shí)間為2015年1月至2018年2月,結(jié)果指標(biāo)分析時(shí)間及試驗(yàn)完成時(shí)間為2018年3月。文章結(jié)果將以科學(xué)會(huì)議報(bào)告,或在同行評(píng)議的期刊上發(fā)表傳播。試驗(yàn)已在中國(guó)臨床試驗(yàn)注冊(cè)中心注冊(cè)(注冊(cè)號(hào):Chi CTR-ROC-17012848)。討論:文章希望通過此試驗(yàn)證實(shí)高原地區(qū)老年男性退行性骨質(zhì)疏松患者氧化應(yīng)激相關(guān)因子和骨代謝指標(biāo)具有相關(guān)性,以進(jìn)一步明確高原地區(qū)老年男性退行性骨質(zhì)疏松的發(fā)病危險(xiǎn)因素,從而為該地區(qū)人群骨質(zhì)疏松發(fā)生及發(fā)展的預(yù)防提供幫助。
[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 偽, 2 偽, 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 偽 (HIF-1 偽) on the 1st day after admission. The changes of serum hypoxia inducible factor 2 偽, 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 偽, 2 偽, 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.
【作者單位】： 青海大學(xué)附屬醫(yī)院創(chuàng)傷骨病科;青海省預(yù)備役旅醫(yī)院骨科;
【分類號(hào)】：R580
，
本文編號(hào)：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 偽, 2 偽, 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 偽 (HIF-1 偽) on the 1st day after admission. The changes of serum hypoxia inducible factor 2 偽, 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 偽, 2 偽, 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.
【作者單位】： 青海大學(xué)附屬醫(yī)院創(chuàng)傷骨病科;青海省預(yù)備役旅醫(yī)院骨科;
【分類號(hào)】：R580
，
本文編號(hào)：2318082
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