Department of Medicine, Section of Emergency and Hyperbaric Medicine, Louisiana State University Health Sciences Center, New Orleans, LA, USA.
Department of Medicine and Psychiatry, School of Medicine, Louisiana State University Health Sciences Center, Metairie, LA, USA.
Med Gas Res. 2020 Jan-Mar;10(1):8-20. doi: 10.4103/2045-9912.279978.
Persistent postconcussion syndrome (PPCS) after mild traumatic brain injury (mTBI) is a significant public health and military problem for which there is limited treatment evidence. The aim of this study was to determine whether forty 150 kPa hyperbaric oxygen therapies (HBOTs) can improve symptoms and cognitive function in subjects with the PPCS of mTBI, using a randomized controlled crossover design with 2-month follow-up. Sixty-three civilian and military subjects with mTBI/PPCS were randomized to either 40 HBOTs at 150 kPa/60 minutes, once daily, 5 days per week in 8 weeks or an equivalent no-treatment control period. The Control Group was then crossed over to HBOT. Subjects underwent symptom, neuropsychological, and psychological testing, before and after treatment or control with retesting 2 months after the 40 HBOT. Fifty subjects completed the protocol with primary outcome testing. HBOT subjects experienced significant improvements in Neurobehavioral Symptom Inventory, Memory Index, Automated Neuropsychological Assessment Metrics, Hamilton Depression Scale, Hamilton Anxiety Scale, Post-Traumatic Stress Disorder Checklist, Pittsburgh Sleep Quality Index, and Quality Of Life after Brain Injury compared to the Control Group. After crossing over to HBOT the Control Group experienced near-identical significant improvements. Further improvements were experienced by both groups during the 2-month follow-up period. These data indicate that 40 HBOTs at 150 kPa/60 minutes demonstrated statistically significant improvements in postconcussion and Post-Traumatic Stress Disorder symptoms, memory, cognitive functions, depression, anxiety, sleep, and quality of life in civilian and military subjects with mTBI/PPCS compared to controls. Improvements persisted at least 2 months after the 40 HBOT. The study was registered on ClinicalTrials.gov (NCT02089594) on March 18, 2014 and with the U.S. Food and Drug Administration under Investigational New Drug #113823. The Institutional Review Boards of the United States Army Medical Research and Materiel Command Office of Research Protections Human Research Protection Office and the Louisiana State University School of Medicine (approval No. 7381) approved the study on May 13, 2014 and December 20, 2013, respectively.
持续性脑震荡后综合征（PPCS）是轻度创伤性脑损伤（mTBI）后的一个严重的公共卫生和军事问题，目前针对这种病症的治疗方法证据有限。本研究的目的是通过随机对照交叉设计和 2 个月的随访，确定 40 次 150kPa 高压氧治疗（HBOT）是否可以改善 mTBI 后 PPCS 患者的症状和认知功能。63 名患有 mTBI/PPCS 的平民和军人被随机分为 40 次 150kPa/60 分钟的高压氧治疗组（每天一次，每周 5 天，持续 8 周）或等效的无治疗对照组。对照组随后交叉接受高压氧治疗。在治疗或对照后以及治疗或对照后 2 个月的重新测试之前，对患者进行症状、神经心理学和心理测试。50 名患者完成了主要结局测试的方案。与对照组相比，高压氧治疗组的神经行为症状量表、记忆指数、自动化神经心理评估指标、汉密尔顿抑郁量表、汉密尔顿焦虑量表、创伤后应激障碍检查表、匹兹堡睡眠质量指数和脑损伤后生活质量均有显著改善。交叉到高压氧治疗组后，对照组也经历了几乎相同的显著改善。两组在 2 个月的随访期间都有进一步的改善。这些数据表明，与对照组相比，40 次 150kPa/60 分钟的高压氧治疗在患有 mTBI/PPCS 的平民和军人患者中，在脑震荡和创伤后应激障碍症状、记忆、认知功能、抑郁、焦虑、睡眠和生活质量方面显示出统计学上的显著改善。在接受 40 次高压氧治疗后至少 2 个月，改善仍在持续。该研究于 2014 年 3 月 18 日在 ClinicalTrials.gov（NCT02089594）注册，并在美国食品和药物管理局根据研究新药 #113823 进行注册。美国陆军医学研究与物资司令部办公室研究保护人体研究保护办公室和路易斯安那州立大学医学院的机构审查委员会（批准号 7381）分别于 2014 年 5 月 13 日和 2013 年 12 月 20 日批准了该研究。
