高压氧及骨科综合治疗高原地区创伤性不完全脊髓损伤:开放性随机对照临床试验

发布时间：2018-08-09 18:52

【摘要】：背景:脊髓损伤后脊髓神经功能因缺血缺氧出现的继发性细胞凋亡是造成脊髓功能难以恢复的主要因素,高原地区因大气压力降低会使患者处于低氧的环境中,对脊髓损伤恢复非常不利,而高压氧能提升组织中氧含量,可能促进患者术后功能的改善。目的:观察高压氧治疗高原地区创伤性脊髓损伤的效果。方法:研究为正在中国青海大学附属医院脊柱外科进行的一项前瞻性开放性随机对照临床试验。164例符合标准的高原地区创伤性不完全脊髓损伤患者,随机分为对照组和高压氧组,各82例。对照组采取椎弓根系统内固定及椎板切除减压等常规外科方法治疗,高压氧组在此基础上,采取0.2 MPa高压氧治疗,1次/d,10次为1个疗程,2个疗程中休息5-7 d,持续4个疗程。主要结局指标为治疗结束后以改良Barthel指数比较治疗前的变化值,其可体现患者日常生活活动能力的变化。次要结局指标为以美国脊髓损伤协会分级、感觉评分和运动评分评价治疗前和治疗结束后相关功能的恢复情况。研究方案已于2012年4月经中国青海大学附属医院伦理委员会批准,批准号QHC011K。试验取得患者亲属或法定代理人的书面知情同意。结果与结论:目前已完成的部分试验结果显示,治疗4个疗程(55-61 d)后高压氧组患者改良巴氏指数、美国脊髓损伤协会触觉、痛觉和运动评分均高于对照组,高压氧组患者和对照组患者美国脊髓损伤协会分级情况差异较大,且高压氧组患者D级和E级所占的比例高于对照组。试验旨在说明高压氧治疗高原地区创伤性不完全脊髓损伤患者的有效性,为高原地区创伤性不完全脊髓损伤患者的高压氧治疗提供临床依据。
[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.
【作者单位】：青海大学附属医院脊柱外科;
【基金】：青海省卫生和计划生育委员会科研项目~~
【分类号】：R651.2

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