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[JAMA发表论文]:院外使用氨甲环酸或安慰剂对中重度颅脑创伤患者6个月后神经功能状态的影响
2020年09月17日 时讯速递, 进展交流 暂无评论

Original Investigation September 8, 2020

Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury

Susan E. Rowell, Eric N. Meier, Barbara McKnight, et al

JAMA. 2020;324(10):961-974. doi:10.1001/jama.2020.8958

Abstract 摘要

Importance 背景

Traumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI.

颅脑创伤(TBI)是创伤致死或致残的首要原因。早期使用氨甲环酸对TBI患者可能有益。

Objective 目的

To determine whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in patients with moderate or severe TBI.

确定在创伤后2小时内院外开始氨甲环酸治疗能否改善中重度TBI患者的神经系统预后。

Design, Setting, and Participants 设计,场景和研究对象

Multicenter, double-blinded, randomized clinical trial at 20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017. Eligible participants (N = 1280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher.

这是一项多中心、双盲、随机临床试验,2015年5月至2017年11月在美国和加拿大的20个创伤中心及39个急救中心进行。入选标准(N = 1280)包括TBI的院外患者,年龄15岁以上,GCS评分不足12分,收缩压不低于90 mmHg。

Interventions 干预措施

Three interventions were evaluated, with treatment initiated within 2 hours of TBI: out-of-hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n = 312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n = 345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n = 309).

评价了在TBI后2小时内开始的三项干预措施:院外氨甲环酸 (1 g) 推注及院内氨甲环酸 (1 g) 8小时输注 (推注维持组; n = 312),院外氨甲环酸 (2 g) 推注及院内安慰剂8小时输注 (仅推注组; n = 345),院外安慰剂推注及院内安慰剂8小时输注 (安慰剂组; n = 309)。

Main Outcomes and Measures 主要预后指标

The primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 [moderate disability or good recovery]) in the combined tranexamic acid group vs the placebo group. Asymmetric significance thresholds were set at 0.1 for benefit and 0.025 for harm. There were 18 secondary end points, of which 5 are reported in this article: 28-day mortality, 6-month Disability Rating Scale score (range, 0 [no disability] to 30 [death]), progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events.

主要预后指标为氨甲环酸联合组6个月时神经系统功能(扩展格拉斯哥结局评分> 4分[中度残疾或恢复良好])优于安慰剂组。非对称性显著差异阈值设为0.1(获益)及0.025(有害)。共有18项次要预后指标,本文报告了其中的5项:28天病死率,6个月伤残评定量表评分(范围0 [无伤残]至30 [死亡],颅内出血进展,癫痫发生率,以及血栓栓塞事件发生率)。

Results 结果

Among 1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants; mean Glasgow Coma Scale score, 8). Of these participants, 819 (84.8%) were available for primary outcome analysis at 6-month follow-up. The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%; [90% 1-sided confidence limit for benefit, −0.9%]; P = .16; [97.5% 1-sided confidence limit for harm, 10.2%]; P = .84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, −2.9% [95% CI, −7.9% to 2.1%]; P = .26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, −0.9 [95% CI, −2.5 to 0.7]; P = .29), or progression of intracranial hemorrhage (16% vs 20%; difference, −5.4% [95% CI, −12.8% to 2.1%]; P = .16).

研究入选1063名患者,其中96名随机分组患者未使用研究药物,1名患者被排除,最终966名患者纳入分析(平均年龄, 42岁; 255名 [74%] 男性; 平均GCS评分, 8)。所有患者中,819名 (84.8%) 患者6个月随访的主要预后分析数据齐全。氨甲环酸组65%的患者和安慰剂组62%的患者发生主要预后 (差异, 3.5%; [获益的90% 单尾区间限, −0.9%]; P = .16; [有害的97.5% 单尾区间限, 10.2%]; P = .84)。氨甲环酸组与安慰剂组28天病死率(14% vs 17%; 差异, −2.9% [95% CI, −7.9% to 2.1%]; P = .26),6个月伤残评定量表评分(6.8 vs 7.6; 差异, −0.9 [95% CI, −2.5 to 0.7]; P = .29),或颅内出血进展 (16% vs 20%; 差异, −5.4% [95% CI, −12.8% to 2.1%]; P = .16)均无显著差异。

Conclusions and Relevance 结论与意义

Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale-Extended.

对于中重度TBI患者,创伤后院外使用氨甲环酸不能显著改善扩展格拉斯哥预后评分测定的6个月神经系统预后。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT01990768

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