Payen Jean-Francois, Vilotitch Antoine, Gauss Tobias, Adolle Anais, Bosson Jean-Luc, Bouzat Pierre
Department of Anaesthesia and Intensive Care, Centre Hospitalier Universitaire Grenoble, and Inserm, U1216, Grenoble Institut Neurosciences, University Grenoble Alpes, Grenoble, France.
Department of Public Health, Centre Hospitalier Universitaire Grenoble, University Grenoble Alpes, Grenoble, France.
J Neurotrauma. 2025 Jun;42(11-12):974-984. doi: 10.1089/neu.2024.0390. Epub 2025 Jan 23.
The effect of sex in outcomes after severe traumatic brain injury (TBI) remains uncertain. We explored whether outcomes differed between women and men after standardized care management during the first 5 days in the intensive care unit (ICU). This study was an observational analysis of the OXY-TC multicenter randomized clinical trial between June 15, 2016 and April 17, 2021. Recruited patients had a pre-hospital Glasgow Coma Scale (GCS) score of 3-8, mechanical ventilation, and intracranial pressure (ICP) with or without brain tissue oxygen pressure (PbtO) monitoring. Objectives were to maintain ICP at 20 mmHg or below and PbtO2 above 20 mmHg at all times. The primary end-point was the proportion of women and men with poor outcomes at 6 months, corresponding to an extended Glasgow Outcome Scale (GOSE) score of 1-4 (death to upper severe disability). Of 318 randomized patients, 200 men and 71 women were analyzed. They were comparable in age, comorbidities, and initial injury severity scores. However, women had larger doses of ICP as the proportion of monitoring time of ICP above 20 mmHg 8% (3-18; median, interquartile range) versus 3% (1-10), respectively ( = 0.002). They required more often at least one tier-3 treatment, i.e., barbiturate coma and therapeutic hypothermia, for refractory intracranial hypertension during the first 5 days in the ICU: 33/68 (48%) versus 60/193 (31%), respectively ( = 0.012). At 6 months, the proportion of women with GOSE 1-4 was significantly higher than men: 48/71 (68%) versus 94/200 (47%), respectively (odds ratio 2.35 [1.33-4.16]; = 0.003]. Similar differences were found using Disability Rating Scale and Functional Independence Measure at 6 and 12 months, and GOSE at 12 months. Sex differences in neurological outcomes persisted after adjustment for other determinants of outcome such as age, initial GCS score, and dose of ICP during the 5-day monitoring. In conclusion, women sustained more severe ICP and required more active treatment, both of which would explain a worse outcome after severe TBI. Prospective research is required to confirm these findings and identify possible mechanisms. Trial registration: ClinicalTrials.gov Identifier NCT02754063 (April 28, 2016).
严重创伤性脑损伤（TBI）后性别对预后的影响仍不确定。我们探讨了在重症监护病房（ICU）的前5天进行标准化护理管理后，女性和男性的预后是否存在差异。本研究是对2016年6月15日至2021年4月17日期间的OXY-TC多中心随机临床试验的观察性分析。招募的患者院前格拉斯哥昏迷量表（GCS）评分为3-8分，接受机械通气，伴有或不伴有脑组织氧分压（PbtO）监测的颅内压（ICP）监测。目标是始终将ICP维持在20 mmHg或以下，将PbtO2维持在20 mmHg以上。主要终点是6个月时预后不良的女性和男性的比例，对应于扩展格拉斯哥预后量表（GOSE）评分为1-4分（从死亡到重度残疾）。在318例随机分组的患者中，分析了200例男性和71例女性。他们在年龄、合并症和初始损伤严重程度评分方面具有可比性。然而，女性的ICP监测时间中ICP高于20 mmHg的比例更大，分别为8%（3-18；中位数，四分位间距）和3%（1-10）（P = 0.002）。在ICU的前5天，她们更常需要至少一种三级治疗，即巴比妥类昏迷和治疗性低温，用于治疗难治性颅内高压：分别为33/68（48%）和60/193（31%）（P = 0.012）。在6个月时，GOSE评分为1-4分的女性比例显著高于男性：分别为48/71（68%）和94/200（47%）（优势比2.35 [1.33-4.16]；P = 0.003）。在6个月和12个月时使用残疾评定量表和功能独立性测量，以及在12个月时使用GOSE，也发现了类似的差异。在对年龄、初始GCS评分和5天监测期间的ICP剂量等其他预后决定因素进行调整后，神经学预后的性别差异仍然存在。总之，女性的ICP更严重且需要更积极的治疗，这两者都可以解释严重TBI后更差的预后。需要进行前瞻性研究来证实这些发现并确定可能的机制。试验注册：ClinicalTrials.gov标识符NCT02754063（2016年4月28日）。
