Williams-Johnson J A, McDonald A H, Strachan G Gordon, Williams E W
West Indian Med J. 2010 Dec;59(6):612-24.
Tranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients.
This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult trauma patients with, or at risk of significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator Both participants and study staff (site investigators and trial coordinating centre staff) were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other AL analyses were by intention to treat. This study is registered as ISRCTN86750102, Clinicaltrials.gov NCT00375258, and South African Clinical Trial Register DOH-27-0607-1919.
10096 patients were allocated to tranexamic acid and 10 115 to placebo, of whom 10060 and 10067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic acid (1463 [14.5%] tranexamic acid group vs 1613 [160%] placebo group; relative risk 0.91, 95% CI 085-097; p = 00035). The risk of death due to bleeding was significantly reduced (489 [49%] vs 574 [5-7%]; relative risk 0-85, 95% CI 0.76-0.96; p = 0-0077).
Tranexamic acid safely reduced the risk of death in bleeding trauma patients in this study On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients.
氨甲环酸可减少择期手术患者的出血。我们评估了早期给予短疗程氨甲环酸对创伤患者死亡、血管闭塞事件及输血情况的影响。
这项随机对照试验在40个国家的274家医院开展。20211例有显著出血或有显著出血风险的成年创伤患者在受伤8小时内被随机分配接受氨甲环酸治疗（负荷剂量1克，10分钟内静脉注射完毕，随后8小时持续静脉输注1克）或匹配的安慰剂。随机分组在各中心间保持均衡，采用计算机随机数字生成器生成基于8的分组大小的分配序列。参与者和研究人员（现场研究人员和试验协调中心工作人员）均对治疗分配情况不知情。主要结局为受伤4周内的院内死亡，按以下类别描述：出血、血管闭塞（心肌梗死、中风和肺栓塞）、多器官功能衰竭、颅脑损伤及其他。所有分析均按意向性分析。本研究已在国际标准随机对照试验编号注册平台注册为ISRCTN86750102，在美国国立医学图书馆临床试验注册平台注册为Clinicaltrials.gov NCT00375258，在南非临床试验注册平台注册为DOH-27-0607-1919。
10096例患者被分配接受氨甲环酸治疗，10115例被分配接受安慰剂治疗，分别对其中10060例和10067例进行分析。氨甲环酸组全因死亡率显著降低（氨甲环酸组1463例[14.5%]，安慰剂组1613例[16.0%]；相对危险度0.91，95%可信区间0.85 - 0.97；p = 0.0035）。因出血导致的死亡风险显著降低（489例[4.9%]对574例[5.7%]；相对危险度0.85，95%可信区间0.76 - 0.96；p = 0.0077）。
在本研究中，氨甲环酸安全降低了出血性创伤患者的死亡风险。基于这些结果，对于出血性创伤患者应考虑使用氨甲环酸。
