Zehtabchi Shahriar, Abdel Baki Samah G, Falzon Louise, Nishijima Daniel K
Department of Emergency Medicine, State University of New York, Downstate Medical Center, Brooklyn, NY.
Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Medical Center, New York, NY.
Am J Emerg Med. 2014 Dec;32(12):1503-9. doi: 10.1016/j.ajem.2014.09.023. Epub 2014 Sep 28.
The antifibrinolytic agent tranexamic acid (TXA) has demonstrated clinical benefit in trauma patients with severe bleeding, but its effectiveness in patients with traumatic brain injury (TBI) is unclear. We conducted a systematic review to evaluate the following research question: In ED patients with or at risk of intracranial hemorrhage (ICH) secondary to TBI, does TXA compared to placebo improve patients' outcomes?
MEDLINE, EMBASE, CINAHL, and other databases were searched for randomized controlled trial (RCT) or quasi-RCT studies that compared the effect of TXA to placebo on outcomes of TBI patients. The main outcomes of interest included mortality, neurologic function, hematoma expansion, and adverse effects. We used "Grading quality of evidence and strength of recommendations" to assess the quality of trials. Two authors independently abstracted data using a data collection form. Results from studies were pooled when appropriate.
Of 1030 references identified through the search, 2 high-quality RCTs met inclusion criteria. The effect of TXA on mortality had a pooled relative risk of 0.64 (95% confidence interval [CI], 0.41-1.02); on unfavorable functional status, a relative risk of 0.77 (95% CI, 0.59-1.02); and on ICH progression, a relative risk of 0.76 (95% CI, 0.58-0.98). No serious adverse effects (such as thromboembolic events) associated with TXA group were reported in the included trials.
Pooled results from the 2 RCTs demonstrated statistically significant reduction in ICH progression with TXA and a nonstatistically significant improvement of clinical outcomes in ED patients with TBI. Further evidence is required to support its routine use in patients with TBI.
抗纤维蛋白溶解剂氨甲环酸(TXA)已在严重出血的创伤患者中显示出临床益处,但其在创伤性脑损伤(TBI)患者中的有效性尚不清楚。我们进行了一项系统评价,以评估以下研究问题:在因TBI继发颅内出血(ICH)或有ICH风险的急诊科(ED)患者中,与安慰剂相比,TXA是否能改善患者的预后?
检索MEDLINE、EMBASE、CINAHL和其他数据库,查找比较TXA与安慰剂对TBI患者预后影响的随机对照试验(RCT)或准RCT研究。主要关注的结局包括死亡率、神经功能、血肿扩大和不良反应。我们使用“证据质量分级和推荐强度”来评估试验质量。两位作者使用数据收集表独立提取数据。适当情况下汇总研究结果。
通过检索确定的1030篇参考文献中,有2项高质量RCT符合纳入标准。TXA对死亡率的合并相对风险为0.64(95%置信区间[CI],0.41 - 1.02);对不良功能状态的相对风险为0.77(95%CI,0.59 - 1.02);对ICH进展的相对风险为0.76(95%CI,0.58 - 0.98)。纳入试验中未报告与TXA组相关的严重不良反应(如血栓栓塞事件)。
2项RCT的汇总结果表明,TXA可使TBI的ED患者ICH进展在统计学上显著降低,临床结局有非统计学意义的改善。需要进一步证据支持其在TBI患者中的常规使用。