BACKGROUND: Apoptosis secondary to ischemia and hypoxia is the main cause of spinal cord dysfunction. Because of the decrease in atmospheric pressure, patients living on the Qinghai-Tibet Plateau are in a hypoxic environment, which is very unfavorable for the recovery of spinal cord injury. Hyperbaric oxygen therapy can improve the postoperative function of patients with incomplete spinal cord injury, and its effect is better on the plateau than at normal altitudes.OBJECTIVE: To observe the effect of hyperbaric oxygen therapy on traumatic spinal cord injury in patients living on the Qinghai–Tibet Plateau.METHODS: This prospective, open-label, randomized controlled clinical trial was performed at the Department of Spine Surgery, Affiliated Hospital of Qinghai University, China. In total, 164 patients with incomplete traumatic spinal cord injury were equally and randomly assigned to a control group and a hyperbaric oxygen therapy group. Patients in the control group were treated with pedicle screw fixation and decompressive laminectomy. In addition to the surgical treatment performed in the control group, patients in the hyperbaric oxygen group underwent hyperbaric oxygen therapy at 0.2 MPa once a day for four treatment courses. Ten treatment sessions constituted one course, and each course was separated by a 5- to 7-day rest interval. The primary outcome was the modified Barthel index to assess activities of daily living. The secondary outcomes were the American Spinal Injury Association (ASIA) impairment scale grade, sensory score, and motor score. The study protocol was approved by the Ethics Committee of the Affiliated Hospital of Qinghai University, China (Approval number: QHC011K). Written informed consent was provided by a relative or legal representative of each patient after they had indicated that they fully understood the treatment plan. RESULTS AND CONCLUSION: The partial results demonstrated that after four treatment courses (55-61 days), the modified Barthel index and ASIA tactile, pain, and motor scores were higher in the hyperbaric oxygen group than in the control group. The ASIA grades were significantly different between the hyperbaric oxygen group and control group. The proportion of patients with ASIA grades D and E was higher in the hyperbaric oxygen group than in the control group. In this trial, we aim to determine the efficacy of hyperbaric oxygen therapy on the treatment of incomplete traumatic spinal cord injury in patients living on the plateau and to provide clinical evidence for treating incomplete traumatic spinal cord injury in these patients.%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.
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