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高壓氧及骨科綜合治療高原地區(qū)創(chuàng)傷性不完全脊髓損傷:開放性隨機對照臨床試驗

發(fā)布時間:2018-08-09 18:52
【摘要】:背景:脊髓損傷后脊髓神經(jīng)功能因缺血缺氧出現(xiàn)的繼發(fā)性細胞凋亡是造成脊髓功能難以恢復的主要因素,高原地區(qū)因大氣壓力降低會使患者處于低氧的環(huán)境中,對脊髓損傷恢復非常不利,而高壓氧能提升組織中氧含量,可能促進患者術后功能的改善。目的:觀察高壓氧治療高原地區(qū)創(chuàng)傷性脊髓損傷的效果。方法:研究為正在中國青海大學附屬醫(yī)院脊柱外科進行的一項前瞻性開放性隨機對照臨床試驗。164例符合標準的高原地區(qū)創(chuàng)傷性不完全脊髓損傷患者,隨機分為對照組和高壓氧組,各82例。對照組采取椎弓根系統(tǒng)內固定及椎板切除減壓等常規(guī)外科方法治療,高壓氧組在此基礎上,采取0.2 MPa高壓氧治療,1次/d,10次為1個療程,2個療程中休息5-7 d,持續(xù)4個療程。主要結局指標為治療結束后以改良Barthel指數(shù)比較治療前的變化值,其可體現(xiàn)患者日常生活活動能力的變化。次要結局指標為以美國脊髓損傷協(xié)會分級、感覺評分和運動評分評價治療前和治療結束后相關功能的恢復情況。研究方案已于2012年4月經(jīng)中國青海大學附屬醫(yī)院倫理委員會批準,批準號QHC011K。試驗取得患者親屬或法定代理人的書面知情同意。結果與結論:目前已完成的部分試驗結果顯示,治療4個療程(55-61 d)后高壓氧組患者改良巴氏指數(shù)、美國脊髓損傷協(xié)會觸覺、痛覺和運動評分均高于對照組,高壓氧組患者和對照組患者美國脊髓損傷協(xié)會分級情況差異較大,且高壓氧組患者D級和E級所占的比例高于對照組。試驗旨在說明高壓氧治療高原地區(qū)創(chuàng)傷性不完全脊髓損傷患者的有效性,為高原地區(qū)創(chuàng)傷性不完全脊髓損傷患者的高壓氧治療提供臨床依據(jù)。
[Abstract]:Background: secondary apoptosis of spinal cord nerve function due to ischemia and hypoxia after spinal cord injury is the main factor causing spinal cord function to recover. Hyperbaric oxygen can increase the content of oxygen in the tissue and may promote the improvement of postoperative function. Objective: to observe the effect of hyperbaric oxygen on traumatic spinal cord injury at high altitude. Methods: a prospective randomized controlled clinical trial of 164 patients with traumatic incomplete spinal cord injury at high altitude was conducted in the Department of Spinal surgery, affiliated Hospital of Qinghai University, China. They were randomly divided into control group and hyperbaric oxygen group with 82 cases each. The control group was treated with conventional surgical methods such as pedicle system fixation and laminectomy and decompression. On this basis, the hyperbaric oxygen group was treated with 0.2 MPa hyperbaric oxygen for 10 times as a course of treatment. The main outcome index was the modified Barthel index after treatment, which could reflect the changes of the patients' activities of daily life. The secondary outcome index was the American Spinal Cord injury Association (Asci) classification, sensory score and motor score to evaluate the recovery of related functions before and after treatment. The research program was approved by the Ethics Committee of Qinghai University affiliated Hospital in April, 2012, and approved No. QHC011K. The trial obtained the written informed consent of the patient's relative or legal representative. Results and conclusion: the results of some trials that have been completed at present show that the modified pasteurization index, tactile, pain and motor scores of patients in the hyperbaric oxygen group after 4 courses of treatment (55-61 days) are higher than those in the control group. The scores of American Spinal Cord injury Association in hyperbaric oxygen group and control group were significantly different, and the proportion of D and E grade in hyperbaric oxygen group was higher than that in control group. The purpose of this study was to demonstrate the efficacy of hyperbaric oxygen in the treatment of traumatic incomplete spinal cord injury at high altitude, and to provide a clinical basis for hyperbaric oxygen therapy in patients with traumatic incomplete spinal cord injury at high altitude.
【作者單位】: 青海大學附屬醫(yī)院脊柱外科;
【基金】:青海省衛(wèi)生和計劃生育委員會科研項目~~
【分類號】:R651.2

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