摘要
目的基于氨甲环酸可以减少择期手术患者出血量的研究基础，观察早期快速静脉注射氨甲环酸对创伤患者死亡率、血管栓塞性并发症和输血量的影响。方法根据随机对照原则设计，在40个国家的274所医院实施，共纳人20211例严重出血或者有严重出血危险的成年患者。于伤后8h内，随机接受氨甲环酸（10min内静脉注射1g，8h内静脉滴注1g）或安慰剂治疗。投药序列中药物或安慰剂的选择由计算机自动生成。患者或研究者均不了解其真实情况。预后的主要评价指标是患者伤后4周的死亡率。死亡原因评价包括出血、血管栓塞性事件（心肌梗死、卒中、肺栓塞）、多器官功能衰竭、脑外伤及其他原因。本研究注册号为ISRCTN86750102。结果10096例患者接受氨甲环酸治疗，10115例患者接受安慰剂注射，两组分别有10060例和10067例患者资料接受进一步分析。药物组患者的总死亡率明显低于安慰剂组，即药物组1463例（14．5％），安慰剂组1613例（16．0％），相对危险度为0．91（95％CI为0．85—0．97，P=0．0035）。因出血导致的患者死亡率明显降低，药物组489例（4．9％），安慰剂组574例（5．7％），相对危险度0．85（95％CI为0．76～0．96，P=0．0077）。结论氨甲环酸可以安全地降低创伤出血患者的死亡率。本研究结果支持在创伤出血患者中使用氨甲环酸。
Objective To assess the effects of early administration of a short course of tranexamic acid on mortality, vascular occlusive events, and blood transfusion in trauma patients. Methods The randomized eontrolled trial was undertaken in 274 hospitals in 40 countries. A total of 20 211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 hours of injury to either tranexamic acid （ intravenous injection of 1 g within 10 minutes after injury and intravenous infusion of 1 g within 8 hours after injury） or matching placebo. The dosing sequence in the choice of drug or pla- cebo was generatod automatically by a computer and the patients or researches did not know the real situation. The primary outcome evaluation was the mortality in hospital within four weeks after injury, and the death cause evaluation included bleeding, vascular occlusion （ myocardial infarction, stroke and pulmona- ry embolism）, muhiorgan failure, head injury, and other causes. In the study, the registration number was ISRCTN86750102. Results A total of 10 096 patients were allocated to tranexamic acid, of whom 10 060 received further analysis and [0 115 to placebo, of whom 10 067 receive further analysis. The overall mortality was significantly reduced, with 1 463 patients （ 14.5% ） in the tranexamic acid group and1 613 patients （ 16.0% ） in the placebo group, with relative risk of 0.91 （95% CI = 0. 85-0. 97 , P = 0. 003 5）. The risk of death due to bleeding was significantly reduced, with 489 patients （4.9%） in the tranexamie acid group and 574 patients （5.7%） in the placebo group, with relative risk of 0.85 （95% CI = 0.76-0.96, P = 0. 007 7 ）. Conclnsion The study shows that tranexamic acid safely reduces the risk of death in bleeding trauma patients, which supports the use of tranexamic acid in bleeding trauma patients.
出处
《中华创伤杂志》
CAS
CSCD
北大核心
2011年第12期1118-1122,共5页
Chinese Journal of Trauma
基金
英国国家卫生研究院健康技术评估计划资助项目
辉瑞公司BUFA基金资助项目
JPMoulton慈善基金资助项目
中国国家自然科学基金面上资助项目（30872671）
上海市浦江人才基金资助项目（2010）
关键词
创伤和损伤
氨甲环酸
并发症
病例对照研究组
Wounds and injuries
Tranexamic wid
Complication
Case-control studies
