早期氨甲环酸治疗对轻度创伤性脑损伤患者疲劳的影响：来自CRASH-3临床试验的数据。
Effect of early tranexamic acid treatment on fatigue in patients with mild traumatic brain injury: data from the CRASH-3 clinical trial.
作者信息
Mansukhani Raoul, Belli Antonio, Brenner Amy, Chaudhri Rizwana, Frimley Lauren, Faizah Jamaluddin Sabariah, Jooma Rashid, Shakur-Still Haleema, Shokunbi Temitayo, Roberts Ian
机构信息
Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
出版信息
Wellcome Open Res. 2024 Oct 28;6:346. doi: 10.12688/wellcomeopenres.17421.2. eCollection 2021.
BACKGROUND
Each year world-wide about 65 million people sustain a mild traumatic brain injury (mTBI). Fatigue is a common and distressing symptom after mTBI. We examine the effect of tranexamic acid (TXA) on fatigue in patients with mTBI using data from the CRASH-3 trial.
METHODS
The CRASH-3 trial randomised 9,202 patients with traumatic brain injury and no significant extracranial bleeding to receive TXA or placebo within 3 hours of injury. The primary outcome was death from head injury within 28 days of injury. The methods and results are presented elsewhere. Fatigue was recorded as "None", "Moderate" or "Extreme." This study examines the effect of TXA on extreme fatigue in the 2,632 patients with mTBI (Glasgow Coma Scale [GCS] score≥13). Our analyses were not prespecified.
RESULTS
Our study primary outcome, extreme fatigue, was reported for 10 (0.8%) of 1,328 patients receiving TXA and 19 (1.5%) of 1,288 patients receiving placebo (risk ratio [RR]=0.51, 95% confidence interval [CI] 0.24-1.09). Death within 28 days of injury was reported for 34 (2.6%) of 1,328 patients receiving TXA versus 47 (3.6%) of 1,288 patients receiving placebo (RR=0.70, 95% CI 0.45-1.08). Among patients allocated to TXA, 44 (3.3%) patients either died or reported extreme fatigue versus 66 (5.1%) patients among those allocated to placebo (RR=0.65, 95% CI 0.44-0.94). This composite outcome is disproportionately influenced by deaths which account for 74% (81 from 110) of events.
CONCLUSIONS
We found no evidence that tranexamic acid reduces fatigue in patients with mTBI. Given, 1) our analyses were not prespecified, 2) our outcome measure is not based on a validated fatigue severity scale, and 3) TBI patients can suffer from hospital-induced delirium, which hinders clinician assessment, these results need to be replicated in another study.
REGISTRATION
ISRCTN (ISRCTN15088122, 19/07/2011), ClinicalTrials.gov (NCT01402882, 26/07/2011), EudraCT (2011-003669-14, 25/07/2011), Pan African Clinical Trial Registry (PACTR20121000441277, 30/10/2012).
背景
全球每年约有6500万人遭受轻度创伤性脑损伤（mTBI）。疲劳是mTBI后常见且令人苦恼的症状。我们使用CRASH-3试验的数据研究氨甲环酸（TXA）对mTBI患者疲劳的影响。
方法
CRASH-3试验将9202例创伤性脑损伤且无明显颅外出血的患者随机分组，在受伤后3小时内给予TXA或安慰剂。主要结局是受伤后28天内死于颅脑损伤。方法和结果已在其他地方发表。疲劳记录为“无”“中度”或“极度”。本研究考察TXA对2632例mTBI患者（格拉斯哥昏迷量表[GCS]评分≥13）极度疲劳的影响。我们的分析未预先设定。
结果
我们研究的主要结局，即极度疲劳，在接受TXA的1328例患者中有10例（0.8%）报告，在接受安慰剂的1288例患者中有19例（1.5%）报告（风险比[RR]=0.51，95%置信区间[CI]0.24 - 1.09）。接受TXA的1328例患者中有34例（2.6%）在受伤后28天内死亡，而接受安慰剂的1288例患者中有47例（3.6%）死亡（RR=0.70，95%CI 0.45 - 1.08）。在分配到TXA组的患者中，44例（3.3%）患者死亡或报告有极度疲劳，而分配到安慰剂组的患者中有66例（5.1%）（RR=0.65，95%CI 0.44 - 0.94）。这一复合结局受死亡影响过大，死亡占事件的74%（110例中的81例）。
结论
我们没有发现证据表明氨甲环酸可减轻mTBI患者的疲劳。鉴于：1）我们分析未预先设定；2）我们的结局指标并非基于经过验证的疲劳严重程度量表；3）TBI患者可能会出现医院诱发的谵妄，这会妨碍临床医生评估，这些结果需要在另一项研究中重复验证。
注册信息
国际标准随机对照试验编号（ISRCTN15088122，2011年7月19日），美国国立医学图书馆临床试验注册中心（NCT01402882，2011年7月26日），欧盟临床试验数据库（2011 - 003669 - 14，2011年7月25日），泛非临床试验注册中心（PACTR20121000441277，2012年10月30日）
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