Susan E.\u00a0Rowell,\u00a0Eric N.\u00a0Meier,\u00a0Barbara\u00a0McKnight,\u00a0et al<\/h3>\n\n\n\nJAMA.\u00a0<\/em>2020;324(10):961-974. doi:10.1001\/jama.2020.8958<\/h3>\n\n\n\nAbstract \u6458\u8981<\/h2>\n\n\n\nImportance<\/strong> \u80cc\u666f<\/h3>\n\n\n\nTraumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI.<\/p>\n\n\n\n
\u9885\u8111\u521b\u4f24(TBI)\u662f\u521b\u4f24\u81f4\u6b7b\u6216\u81f4\u6b8b\u7684\u9996\u8981\u539f\u56e0\u3002\u65e9\u671f\u4f7f\u7528\u6c28\u7532\u73af\u9178\u5bf9TBI\u60a3\u8005\u53ef\u80fd\u6709\u76ca\u3002<\/p>\n\n\n\n
Objective<\/strong>\u00a0\u76ee\u7684<\/h3>\n\n\n\nTo 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.<\/p>\n\n\n\n
\u786e\u5b9a\u5728\u521b\u4f24\u540e2\u5c0f\u65f6\u5185\u9662\u5916\u5f00\u59cb\u6c28\u7532\u73af\u9178\u6cbb\u7597\u80fd\u5426\u6539\u5584\u4e2d\u91cd\u5ea6TBI\u60a3\u8005\u7684\u795e\u7ecf\u7cfb\u7edf\u9884\u540e\u3002<\/p>\n\n\n\n
Design, Setting, and Participants<\/strong>\u00a0\u8bbe\u8ba1\uff0c\u573a\u666f\u548c\u7814\u7a76\u5bf9\u8c61<\/h3>\n\n\n\nMulticenter, 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\u2009=\u20091280) 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.<\/p>\n\n\n\n
\u8fd9\u662f\u4e00\u9879\u591a\u4e2d\u5fc3\u3001\u53cc\u76f2\u3001\u968f\u673a\u4e34\u5e8a\u8bd5\u9a8c\uff0c2015\u5e745\u6708\u81f32017\u5e7411\u6708\u5728\u7f8e\u56fd\u548c\u52a0\u62ff\u5927\u768420\u4e2a\u521b\u4f24\u4e2d\u5fc3\u53ca39\u4e2a\u6025\u6551\u4e2d\u5fc3\u8fdb\u884c\u3002\u5165\u9009\u6807\u51c6(N\u2009=\u20091280)\u5305\u62ecTBI\u7684\u9662\u5916\u60a3\u8005\uff0c\u5e74\u9f8415\u5c81\u4ee5\u4e0a\uff0cGCS\u8bc4\u5206\u4e0d\u8db312\u5206\uff0c\u6536\u7f29\u538b\u4e0d\u4f4e\u4e8e90 mmHg\u3002<\/p>\n\n\n\n
Interventions<\/strong>\u00a0\u5e72\u9884\u63aa\u65bd<\/h3>\n\n\n\nThree 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\u2009=\u2009312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n\u2009=\u2009345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n\u2009=\u2009309).<\/p>\n\n\n\n
\u8bc4\u4ef7\u4e86\u5728TBI\u540e2\u5c0f\u65f6\u5185\u5f00\u59cb\u7684\u4e09\u9879\u5e72\u9884\u63aa\u65bd\uff1a\u9662\u5916\u6c28\u7532\u73af\u9178 (1 g) \u63a8\u6ce8\u53ca\u9662\u5185\u6c28\u7532\u73af\u9178 (1 g) 8\u5c0f\u65f6\u8f93\u6ce8 (\u63a8\u6ce8\u7ef4\u6301\u7ec4; n\u2009=\u2009312)\uff0c\u9662\u5916\u6c28\u7532\u73af\u9178 (2 g) \u63a8\u6ce8\u53ca\u9662\u5185\u5b89\u6170\u52428\u5c0f\u65f6\u8f93\u6ce8 (\u4ec5\u63a8\u6ce8\u7ec4; n\u2009=\u2009345)\uff0c\u9662\u5916\u5b89\u6170\u5242\u63a8\u6ce8\u53ca\u9662\u5185\u5b89\u6170\u52428\u5c0f\u65f6\u8f93\u6ce8 (\u5b89\u6170\u5242\u7ec4; n\u2009=\u2009309)\u3002<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong>\u00a0\u4e3b\u8981\u9884\u540e\u6307\u6807<\/h3>\n\n\n\nThe 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.<\/p>\n\n\n\n
\u4e3b\u8981\u9884\u540e\u6307\u6807\u4e3a\u6c28\u7532\u73af\u9178\u8054\u5408\u7ec46\u4e2a\u6708\u65f6\u795e\u7ecf\u7cfb\u7edf\u529f\u80fd\uff08\u6269\u5c55\u683c\u62c9\u65af\u54e5\u7ed3\u5c40\u8bc4\u5206> 4\u5206[\u4e2d\u5ea6\u6b8b\u75be\u6216\u6062\u590d\u826f\u597d]\uff09\u4f18\u4e8e\u5b89\u6170\u5242\u7ec4\u3002\u975e\u5bf9\u79f0\u6027\u663e\u8457\u5dee\u5f02\u9608\u503c\u8bbe\u4e3a0.1\uff08\u83b7\u76ca\uff09\u53ca0.025\uff08\u6709\u5bb3\uff09\u3002\u5171\u670918\u9879\u6b21\u8981\u9884\u540e\u6307\u6807\uff0c\u672c\u6587\u62a5\u544a\u4e86\u5176\u4e2d\u76845\u9879\uff1a28\u5929\u75c5\u6b7b\u7387\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206\uff08\u8303\u56f40 [\u65e0\u4f24\u6b8b]\u81f330 [\u6b7b\u4ea1]\uff0c\u9885\u5185\u51fa\u8840\u8fdb\u5c55\uff0c\u766b\u75eb\u53d1\u751f\u7387\uff0c\u4ee5\u53ca\u8840\u6813\u6813\u585e\u4e8b\u4ef6\u53d1\u751f\u7387\uff09\u3002<\/p>\n\n\n\n
Results<\/strong>\u00a0\u7ed3\u679c<\/h3>\n\n\n\nAmong 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, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [97.5% 1-sided confidence limit for harm, 10.2%];\u00a0P<\/em>\u2009=\u2009.84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29), or progression of intracranial hemorrhage (16% vs 20%; difference, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16).<\/p>\n\n\n\n\u7814\u7a76\u5165\u90091063\u540d\u60a3\u8005\uff0c\u5176\u4e2d96\u540d\u968f\u673a\u5206\u7ec4\u60a3\u8005\u672a\u4f7f\u7528\u7814\u7a76\u836f\u7269\uff0c1\u540d\u60a3\u8005\u88ab\u6392\u9664\uff0c\u6700\u7ec8966\u540d\u60a3\u8005\u7eb3\u5165\u5206\u6790(\u5e73\u5747\u5e74\u9f84, 42\u5c81; 255\u540d [74%] \u7537\u6027; \u5e73\u5747GCS\u8bc4\u5206, 8)\u3002\u6240\u6709\u60a3\u8005\u4e2d\uff0c819\u540d (84.8%) \u60a3\u80056\u4e2a\u6708\u968f\u8bbf\u7684\u4e3b\u8981\u9884\u540e\u5206\u6790\u6570\u636e\u9f50\u5168\u3002\u6c28\u7532\u73af\u9178\u7ec465%\u7684\u60a3\u8005\u548c\u5b89\u6170\u5242\u7ec462%\u7684\u60a3\u8005\u53d1\u751f\u4e3b\u8981\u9884\u540e (\u5dee\u5f02, 3.5%; [\u83b7\u76ca\u768490% \u5355\u5c3e\u533a\u95f4\u9650, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [\u6709\u5bb3\u768497.5% \u5355\u5c3e\u533a\u95f4\u9650, 10.2%];\u00a0P<\/em>\u2009=\u2009.84)\u3002\u6c28\u7532\u73af\u9178\u7ec4\u4e0e\u5b89\u6170\u5242\u7ec428\u5929\u75c5\u6b7b\u7387(14% vs 17%; \u5dee\u5f02, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26)\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206(6.8 vs 7.6; \u5dee\u5f02, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29)\uff0c\u6216\u9885\u5185\u51fa\u8840\u8fdb\u5c55 (16% vs 20%; \u5dee\u5f02, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16)\u5747\u65e0\u663e\u8457\u5dee\u5f02\u3002<\/p>\n\n\n\n![\"\"\/](\"https:\/\/cdn.jamanetwork.com\/ama\/content_public\/journal\/jama\/938551\/joi200057va_1599242831.51615.png?Expires=2147483647&Signature=2HfgiQKKkoTW1298UFJ5a2s5ySFjKNmslmXSjS~DgKJA3wsBkiVpwL9bS2Aw9fXG03h3Aipd-tMs1JwLJzhpUI1l-6MTU~C9qu7kUYODEJaC3rJcvf9RNrzh38K-aHWWoruKlyriSQlNSTlqmxTKS-K~we81eJE05pLi5oXXeOLwxirVnDowLsfMFLBfLzhbnt5RbDNRuzgpXNtPAghNAxl8ZUBnJHMKOSwLYEjiiKkwo7HDaFIKESNq~yINenJgxAY5LHHJaELdbqvpd0wKu40Z~c9HNKKc4lr1wZvbUgTUrQ1V1I-syn62~37A1knrEwVPZzHTM0Gy8ODReTCFow__&Key-Pair-Id=APKAIE5G5CRDK6RD3PGA\")
<\/figure>\n\n\n\nConclusions and Relevance<\/strong> \u7ed3\u8bba\u4e0e\u610f\u4e49<\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
\u5bf9\u4e8e\u4e2d\u91cd\u5ea6TBI\u60a3\u8005\uff0c\u521b\u4f24\u540e\u9662\u5916\u4f7f\u7528\u6c28\u7532\u73af\u9178\u4e0d\u80fd\u663e\u8457\u6539\u5584\u6269\u5c55\u683c\u62c9\u65af\u54e5\u9884\u540e\u8bc4\u5206\u6d4b\u5b9a\u76846\u4e2a\u6708\u795e\u7ecf\u7cfb\u7edf\u9884\u540e\u3002<\/p>\n\n\n\n
Trial Registration<\/strong>\u00a0\u8bd5\u9a8c\u6ce8\u518c<\/h3>\n\n\n\n
Abstract \u6458\u8981<\/h2>\n\n\n\nImportance<\/strong> \u80cc\u666f<\/h3>\n\n\n\nTraumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI.<\/p>\n\n\n\n
\u9885\u8111\u521b\u4f24(TBI)\u662f\u521b\u4f24\u81f4\u6b7b\u6216\u81f4\u6b8b\u7684\u9996\u8981\u539f\u56e0\u3002\u65e9\u671f\u4f7f\u7528\u6c28\u7532\u73af\u9178\u5bf9TBI\u60a3\u8005\u53ef\u80fd\u6709\u76ca\u3002<\/p>\n\n\n\n
Objective<\/strong>\u00a0\u76ee\u7684<\/h3>\n\n\n\nTo 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.<\/p>\n\n\n\n
\u786e\u5b9a\u5728\u521b\u4f24\u540e2\u5c0f\u65f6\u5185\u9662\u5916\u5f00\u59cb\u6c28\u7532\u73af\u9178\u6cbb\u7597\u80fd\u5426\u6539\u5584\u4e2d\u91cd\u5ea6TBI\u60a3\u8005\u7684\u795e\u7ecf\u7cfb\u7edf\u9884\u540e\u3002<\/p>\n\n\n\n
Design, Setting, and Participants<\/strong>\u00a0\u8bbe\u8ba1\uff0c\u573a\u666f\u548c\u7814\u7a76\u5bf9\u8c61<\/h3>\n\n\n\nMulticenter, 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\u2009=\u20091280) 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.<\/p>\n\n\n\n
\u8fd9\u662f\u4e00\u9879\u591a\u4e2d\u5fc3\u3001\u53cc\u76f2\u3001\u968f\u673a\u4e34\u5e8a\u8bd5\u9a8c\uff0c2015\u5e745\u6708\u81f32017\u5e7411\u6708\u5728\u7f8e\u56fd\u548c\u52a0\u62ff\u5927\u768420\u4e2a\u521b\u4f24\u4e2d\u5fc3\u53ca39\u4e2a\u6025\u6551\u4e2d\u5fc3\u8fdb\u884c\u3002\u5165\u9009\u6807\u51c6(N\u2009=\u20091280)\u5305\u62ecTBI\u7684\u9662\u5916\u60a3\u8005\uff0c\u5e74\u9f8415\u5c81\u4ee5\u4e0a\uff0cGCS\u8bc4\u5206\u4e0d\u8db312\u5206\uff0c\u6536\u7f29\u538b\u4e0d\u4f4e\u4e8e90 mmHg\u3002<\/p>\n\n\n\n
Interventions<\/strong>\u00a0\u5e72\u9884\u63aa\u65bd<\/h3>\n\n\n\nThree 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\u2009=\u2009312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n\u2009=\u2009345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n\u2009=\u2009309).<\/p>\n\n\n\n
\u8bc4\u4ef7\u4e86\u5728TBI\u540e2\u5c0f\u65f6\u5185\u5f00\u59cb\u7684\u4e09\u9879\u5e72\u9884\u63aa\u65bd\uff1a\u9662\u5916\u6c28\u7532\u73af\u9178 (1 g) \u63a8\u6ce8\u53ca\u9662\u5185\u6c28\u7532\u73af\u9178 (1 g) 8\u5c0f\u65f6\u8f93\u6ce8 (\u63a8\u6ce8\u7ef4\u6301\u7ec4; n\u2009=\u2009312)\uff0c\u9662\u5916\u6c28\u7532\u73af\u9178 (2 g) \u63a8\u6ce8\u53ca\u9662\u5185\u5b89\u6170\u52428\u5c0f\u65f6\u8f93\u6ce8 (\u4ec5\u63a8\u6ce8\u7ec4; n\u2009=\u2009345)\uff0c\u9662\u5916\u5b89\u6170\u5242\u63a8\u6ce8\u53ca\u9662\u5185\u5b89\u6170\u52428\u5c0f\u65f6\u8f93\u6ce8 (\u5b89\u6170\u5242\u7ec4; n\u2009=\u2009309)\u3002<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong>\u00a0\u4e3b\u8981\u9884\u540e\u6307\u6807<\/h3>\n\n\n\nThe 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.<\/p>\n\n\n\n
\u4e3b\u8981\u9884\u540e\u6307\u6807\u4e3a\u6c28\u7532\u73af\u9178\u8054\u5408\u7ec46\u4e2a\u6708\u65f6\u795e\u7ecf\u7cfb\u7edf\u529f\u80fd\uff08\u6269\u5c55\u683c\u62c9\u65af\u54e5\u7ed3\u5c40\u8bc4\u5206> 4\u5206[\u4e2d\u5ea6\u6b8b\u75be\u6216\u6062\u590d\u826f\u597d]\uff09\u4f18\u4e8e\u5b89\u6170\u5242\u7ec4\u3002\u975e\u5bf9\u79f0\u6027\u663e\u8457\u5dee\u5f02\u9608\u503c\u8bbe\u4e3a0.1\uff08\u83b7\u76ca\uff09\u53ca0.025\uff08\u6709\u5bb3\uff09\u3002\u5171\u670918\u9879\u6b21\u8981\u9884\u540e\u6307\u6807\uff0c\u672c\u6587\u62a5\u544a\u4e86\u5176\u4e2d\u76845\u9879\uff1a28\u5929\u75c5\u6b7b\u7387\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206\uff08\u8303\u56f40 [\u65e0\u4f24\u6b8b]\u81f330 [\u6b7b\u4ea1]\uff0c\u9885\u5185\u51fa\u8840\u8fdb\u5c55\uff0c\u766b\u75eb\u53d1\u751f\u7387\uff0c\u4ee5\u53ca\u8840\u6813\u6813\u585e\u4e8b\u4ef6\u53d1\u751f\u7387\uff09\u3002<\/p>\n\n\n\n
Results<\/strong>\u00a0\u7ed3\u679c<\/h3>\n\n\n\nAmong 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, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [97.5% 1-sided confidence limit for harm, 10.2%];\u00a0P<\/em>\u2009=\u2009.84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29), or progression of intracranial hemorrhage (16% vs 20%; difference, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16).<\/p>\n\n\n\n\u7814\u7a76\u5165\u90091063\u540d\u60a3\u8005\uff0c\u5176\u4e2d96\u540d\u968f\u673a\u5206\u7ec4\u60a3\u8005\u672a\u4f7f\u7528\u7814\u7a76\u836f\u7269\uff0c1\u540d\u60a3\u8005\u88ab\u6392\u9664\uff0c\u6700\u7ec8966\u540d\u60a3\u8005\u7eb3\u5165\u5206\u6790(\u5e73\u5747\u5e74\u9f84, 42\u5c81; 255\u540d [74%] \u7537\u6027; \u5e73\u5747GCS\u8bc4\u5206, 8)\u3002\u6240\u6709\u60a3\u8005\u4e2d\uff0c819\u540d (84.8%) \u60a3\u80056\u4e2a\u6708\u968f\u8bbf\u7684\u4e3b\u8981\u9884\u540e\u5206\u6790\u6570\u636e\u9f50\u5168\u3002\u6c28\u7532\u73af\u9178\u7ec465%\u7684\u60a3\u8005\u548c\u5b89\u6170\u5242\u7ec462%\u7684\u60a3\u8005\u53d1\u751f\u4e3b\u8981\u9884\u540e (\u5dee\u5f02, 3.5%; [\u83b7\u76ca\u768490% \u5355\u5c3e\u533a\u95f4\u9650, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [\u6709\u5bb3\u768497.5% \u5355\u5c3e\u533a\u95f4\u9650, 10.2%];\u00a0P<\/em>\u2009=\u2009.84)\u3002\u6c28\u7532\u73af\u9178\u7ec4\u4e0e\u5b89\u6170\u5242\u7ec428\u5929\u75c5\u6b7b\u7387(14% vs 17%; \u5dee\u5f02, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26)\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206(6.8 vs 7.6; \u5dee\u5f02, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29)\uff0c\u6216\u9885\u5185\u51fa\u8840\u8fdb\u5c55 (16% vs 20%; \u5dee\u5f02, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16)\u5747\u65e0\u663e\u8457\u5dee\u5f02\u3002<\/p>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong> \u7ed3\u8bba\u4e0e\u610f\u4e49<\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
\u5bf9\u4e8e\u4e2d\u91cd\u5ea6TBI\u60a3\u8005\uff0c\u521b\u4f24\u540e\u9662\u5916\u4f7f\u7528\u6c28\u7532\u73af\u9178\u4e0d\u80fd\u663e\u8457\u6539\u5584\u6269\u5c55\u683c\u62c9\u65af\u54e5\u9884\u540e\u8bc4\u5206\u6d4b\u5b9a\u76846\u4e2a\u6708\u795e\u7ecf\u7cfb\u7edf\u9884\u540e\u3002<\/p>\n\n\n\n
Trial Registration<\/strong>\u00a0\u8bd5\u9a8c\u6ce8\u518c<\/h3>\n\n\n\n
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.<\/p>\n\n\n\n
\u9885\u8111\u521b\u4f24(TBI)\u662f\u521b\u4f24\u81f4\u6b7b\u6216\u81f4\u6b8b\u7684\u9996\u8981\u539f\u56e0\u3002\u65e9\u671f\u4f7f\u7528\u6c28\u7532\u73af\u9178\u5bf9TBI\u60a3\u8005\u53ef\u80fd\u6709\u76ca\u3002<\/p>\n\n\n\n
Objective<\/strong>\u00a0\u76ee\u7684<\/h3>\n\n\n\nTo 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.<\/p>\n\n\n\n
\u786e\u5b9a\u5728\u521b\u4f24\u540e2\u5c0f\u65f6\u5185\u9662\u5916\u5f00\u59cb\u6c28\u7532\u73af\u9178\u6cbb\u7597\u80fd\u5426\u6539\u5584\u4e2d\u91cd\u5ea6TBI\u60a3\u8005\u7684\u795e\u7ecf\u7cfb\u7edf\u9884\u540e\u3002<\/p>\n\n\n\n
Design, Setting, and Participants<\/strong>\u00a0\u8bbe\u8ba1\uff0c\u573a\u666f\u548c\u7814\u7a76\u5bf9\u8c61<\/h3>\n\n\n\nMulticenter, 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\u2009=\u20091280) 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.<\/p>\n\n\n\n
\u8fd9\u662f\u4e00\u9879\u591a\u4e2d\u5fc3\u3001\u53cc\u76f2\u3001\u968f\u673a\u4e34\u5e8a\u8bd5\u9a8c\uff0c2015\u5e745\u6708\u81f32017\u5e7411\u6708\u5728\u7f8e\u56fd\u548c\u52a0\u62ff\u5927\u768420\u4e2a\u521b\u4f24\u4e2d\u5fc3\u53ca39\u4e2a\u6025\u6551\u4e2d\u5fc3\u8fdb\u884c\u3002\u5165\u9009\u6807\u51c6(N\u2009=\u20091280)\u5305\u62ecTBI\u7684\u9662\u5916\u60a3\u8005\uff0c\u5e74\u9f8415\u5c81\u4ee5\u4e0a\uff0cGCS\u8bc4\u5206\u4e0d\u8db312\u5206\uff0c\u6536\u7f29\u538b\u4e0d\u4f4e\u4e8e90 mmHg\u3002<\/p>\n\n\n\n
Interventions<\/strong>\u00a0\u5e72\u9884\u63aa\u65bd<\/h3>\n\n\n\nThree 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\u2009=\u2009312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n\u2009=\u2009345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n\u2009=\u2009309).<\/p>\n\n\n\n
\u8bc4\u4ef7\u4e86\u5728TBI\u540e2\u5c0f\u65f6\u5185\u5f00\u59cb\u7684\u4e09\u9879\u5e72\u9884\u63aa\u65bd\uff1a\u9662\u5916\u6c28\u7532\u73af\u9178 (1 g) \u63a8\u6ce8\u53ca\u9662\u5185\u6c28\u7532\u73af\u9178 (1 g) 8\u5c0f\u65f6\u8f93\u6ce8 (\u63a8\u6ce8\u7ef4\u6301\u7ec4; n\u2009=\u2009312)\uff0c\u9662\u5916\u6c28\u7532\u73af\u9178 (2 g) \u63a8\u6ce8\u53ca\u9662\u5185\u5b89\u6170\u52428\u5c0f\u65f6\u8f93\u6ce8 (\u4ec5\u63a8\u6ce8\u7ec4; n\u2009=\u2009345)\uff0c\u9662\u5916\u5b89\u6170\u5242\u63a8\u6ce8\u53ca\u9662\u5185\u5b89\u6170\u52428\u5c0f\u65f6\u8f93\u6ce8 (\u5b89\u6170\u5242\u7ec4; n\u2009=\u2009309)\u3002<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong>\u00a0\u4e3b\u8981\u9884\u540e\u6307\u6807<\/h3>\n\n\n\nThe 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.<\/p>\n\n\n\n
\u4e3b\u8981\u9884\u540e\u6307\u6807\u4e3a\u6c28\u7532\u73af\u9178\u8054\u5408\u7ec46\u4e2a\u6708\u65f6\u795e\u7ecf\u7cfb\u7edf\u529f\u80fd\uff08\u6269\u5c55\u683c\u62c9\u65af\u54e5\u7ed3\u5c40\u8bc4\u5206> 4\u5206[\u4e2d\u5ea6\u6b8b\u75be\u6216\u6062\u590d\u826f\u597d]\uff09\u4f18\u4e8e\u5b89\u6170\u5242\u7ec4\u3002\u975e\u5bf9\u79f0\u6027\u663e\u8457\u5dee\u5f02\u9608\u503c\u8bbe\u4e3a0.1\uff08\u83b7\u76ca\uff09\u53ca0.025\uff08\u6709\u5bb3\uff09\u3002\u5171\u670918\u9879\u6b21\u8981\u9884\u540e\u6307\u6807\uff0c\u672c\u6587\u62a5\u544a\u4e86\u5176\u4e2d\u76845\u9879\uff1a28\u5929\u75c5\u6b7b\u7387\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206\uff08\u8303\u56f40 [\u65e0\u4f24\u6b8b]\u81f330 [\u6b7b\u4ea1]\uff0c\u9885\u5185\u51fa\u8840\u8fdb\u5c55\uff0c\u766b\u75eb\u53d1\u751f\u7387\uff0c\u4ee5\u53ca\u8840\u6813\u6813\u585e\u4e8b\u4ef6\u53d1\u751f\u7387\uff09\u3002<\/p>\n\n\n\n
Results<\/strong>\u00a0\u7ed3\u679c<\/h3>\n\n\n\nAmong 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, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [97.5% 1-sided confidence limit for harm, 10.2%];\u00a0P<\/em>\u2009=\u2009.84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29), or progression of intracranial hemorrhage (16% vs 20%; difference, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16).<\/p>\n\n\n\n\u7814\u7a76\u5165\u90091063\u540d\u60a3\u8005\uff0c\u5176\u4e2d96\u540d\u968f\u673a\u5206\u7ec4\u60a3\u8005\u672a\u4f7f\u7528\u7814\u7a76\u836f\u7269\uff0c1\u540d\u60a3\u8005\u88ab\u6392\u9664\uff0c\u6700\u7ec8966\u540d\u60a3\u8005\u7eb3\u5165\u5206\u6790(\u5e73\u5747\u5e74\u9f84, 42\u5c81; 255\u540d [74%] \u7537\u6027; \u5e73\u5747GCS\u8bc4\u5206, 8)\u3002\u6240\u6709\u60a3\u8005\u4e2d\uff0c819\u540d (84.8%) \u60a3\u80056\u4e2a\u6708\u968f\u8bbf\u7684\u4e3b\u8981\u9884\u540e\u5206\u6790\u6570\u636e\u9f50\u5168\u3002\u6c28\u7532\u73af\u9178\u7ec465%\u7684\u60a3\u8005\u548c\u5b89\u6170\u5242\u7ec462%\u7684\u60a3\u8005\u53d1\u751f\u4e3b\u8981\u9884\u540e (\u5dee\u5f02, 3.5%; [\u83b7\u76ca\u768490% \u5355\u5c3e\u533a\u95f4\u9650, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [\u6709\u5bb3\u768497.5% \u5355\u5c3e\u533a\u95f4\u9650, 10.2%];\u00a0P<\/em>\u2009=\u2009.84)\u3002\u6c28\u7532\u73af\u9178\u7ec4\u4e0e\u5b89\u6170\u5242\u7ec428\u5929\u75c5\u6b7b\u7387(14% vs 17%; \u5dee\u5f02, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26)\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206(6.8 vs 7.6; \u5dee\u5f02, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29)\uff0c\u6216\u9885\u5185\u51fa\u8840\u8fdb\u5c55 (16% vs 20%; \u5dee\u5f02, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16)\u5747\u65e0\u663e\u8457\u5dee\u5f02\u3002<\/p>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong> \u7ed3\u8bba\u4e0e\u610f\u4e49<\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
\u5bf9\u4e8e\u4e2d\u91cd\u5ea6TBI\u60a3\u8005\uff0c\u521b\u4f24\u540e\u9662\u5916\u4f7f\u7528\u6c28\u7532\u73af\u9178\u4e0d\u80fd\u663e\u8457\u6539\u5584\u6269\u5c55\u683c\u62c9\u65af\u54e5\u9884\u540e\u8bc4\u5206\u6d4b\u5b9a\u76846\u4e2a\u6708\u795e\u7ecf\u7cfb\u7edf\u9884\u540e\u3002<\/p>\n\n\n\n
Trial Registration<\/strong>\u00a0\u8bd5\u9a8c\u6ce8\u518c<\/h3>\n\n\n\n
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\u2009=\u20091280) 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.<\/p>\n\n\n\n
\u8fd9\u662f\u4e00\u9879\u591a\u4e2d\u5fc3\u3001\u53cc\u76f2\u3001\u968f\u673a\u4e34\u5e8a\u8bd5\u9a8c\uff0c2015\u5e745\u6708\u81f32017\u5e7411\u6708\u5728\u7f8e\u56fd\u548c\u52a0\u62ff\u5927\u768420\u4e2a\u521b\u4f24\u4e2d\u5fc3\u53ca39\u4e2a\u6025\u6551\u4e2d\u5fc3\u8fdb\u884c\u3002\u5165\u9009\u6807\u51c6(N\u2009=\u20091280)\u5305\u62ecTBI\u7684\u9662\u5916\u60a3\u8005\uff0c\u5e74\u9f8415\u5c81\u4ee5\u4e0a\uff0cGCS\u8bc4\u5206\u4e0d\u8db312\u5206\uff0c\u6536\u7f29\u538b\u4e0d\u4f4e\u4e8e90 mmHg\u3002<\/p>\n\n\n\n
Interventions<\/strong>\u00a0\u5e72\u9884\u63aa\u65bd<\/h3>\n\n\n\nThree 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\u2009=\u2009312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n\u2009=\u2009345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n\u2009=\u2009309).<\/p>\n\n\n\n
\u8bc4\u4ef7\u4e86\u5728TBI\u540e2\u5c0f\u65f6\u5185\u5f00\u59cb\u7684\u4e09\u9879\u5e72\u9884\u63aa\u65bd\uff1a\u9662\u5916\u6c28\u7532\u73af\u9178 (1 g) \u63a8\u6ce8\u53ca\u9662\u5185\u6c28\u7532\u73af\u9178 (1 g) 8\u5c0f\u65f6\u8f93\u6ce8 (\u63a8\u6ce8\u7ef4\u6301\u7ec4; n\u2009=\u2009312)\uff0c\u9662\u5916\u6c28\u7532\u73af\u9178 (2 g) \u63a8\u6ce8\u53ca\u9662\u5185\u5b89\u6170\u52428\u5c0f\u65f6\u8f93\u6ce8 (\u4ec5\u63a8\u6ce8\u7ec4; n\u2009=\u2009345)\uff0c\u9662\u5916\u5b89\u6170\u5242\u63a8\u6ce8\u53ca\u9662\u5185\u5b89\u6170\u52428\u5c0f\u65f6\u8f93\u6ce8 (\u5b89\u6170\u5242\u7ec4; n\u2009=\u2009309)\u3002<\/p>\n\n\n\n
Main Outcomes and Measures<\/strong>\u00a0\u4e3b\u8981\u9884\u540e\u6307\u6807<\/h3>\n\n\n\nThe 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.<\/p>\n\n\n\n
\u4e3b\u8981\u9884\u540e\u6307\u6807\u4e3a\u6c28\u7532\u73af\u9178\u8054\u5408\u7ec46\u4e2a\u6708\u65f6\u795e\u7ecf\u7cfb\u7edf\u529f\u80fd\uff08\u6269\u5c55\u683c\u62c9\u65af\u54e5\u7ed3\u5c40\u8bc4\u5206> 4\u5206[\u4e2d\u5ea6\u6b8b\u75be\u6216\u6062\u590d\u826f\u597d]\uff09\u4f18\u4e8e\u5b89\u6170\u5242\u7ec4\u3002\u975e\u5bf9\u79f0\u6027\u663e\u8457\u5dee\u5f02\u9608\u503c\u8bbe\u4e3a0.1\uff08\u83b7\u76ca\uff09\u53ca0.025\uff08\u6709\u5bb3\uff09\u3002\u5171\u670918\u9879\u6b21\u8981\u9884\u540e\u6307\u6807\uff0c\u672c\u6587\u62a5\u544a\u4e86\u5176\u4e2d\u76845\u9879\uff1a28\u5929\u75c5\u6b7b\u7387\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206\uff08\u8303\u56f40 [\u65e0\u4f24\u6b8b]\u81f330 [\u6b7b\u4ea1]\uff0c\u9885\u5185\u51fa\u8840\u8fdb\u5c55\uff0c\u766b\u75eb\u53d1\u751f\u7387\uff0c\u4ee5\u53ca\u8840\u6813\u6813\u585e\u4e8b\u4ef6\u53d1\u751f\u7387\uff09\u3002<\/p>\n\n\n\n
Results<\/strong>\u00a0\u7ed3\u679c<\/h3>\n\n\n\nAmong 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, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [97.5% 1-sided confidence limit for harm, 10.2%];\u00a0P<\/em>\u2009=\u2009.84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29), or progression of intracranial hemorrhage (16% vs 20%; difference, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16).<\/p>\n\n\n\n\u7814\u7a76\u5165\u90091063\u540d\u60a3\u8005\uff0c\u5176\u4e2d96\u540d\u968f\u673a\u5206\u7ec4\u60a3\u8005\u672a\u4f7f\u7528\u7814\u7a76\u836f\u7269\uff0c1\u540d\u60a3\u8005\u88ab\u6392\u9664\uff0c\u6700\u7ec8966\u540d\u60a3\u8005\u7eb3\u5165\u5206\u6790(\u5e73\u5747\u5e74\u9f84, 42\u5c81; 255\u540d [74%] \u7537\u6027; \u5e73\u5747GCS\u8bc4\u5206, 8)\u3002\u6240\u6709\u60a3\u8005\u4e2d\uff0c819\u540d (84.8%) \u60a3\u80056\u4e2a\u6708\u968f\u8bbf\u7684\u4e3b\u8981\u9884\u540e\u5206\u6790\u6570\u636e\u9f50\u5168\u3002\u6c28\u7532\u73af\u9178\u7ec465%\u7684\u60a3\u8005\u548c\u5b89\u6170\u5242\u7ec462%\u7684\u60a3\u8005\u53d1\u751f\u4e3b\u8981\u9884\u540e (\u5dee\u5f02, 3.5%; [\u83b7\u76ca\u768490% \u5355\u5c3e\u533a\u95f4\u9650, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [\u6709\u5bb3\u768497.5% \u5355\u5c3e\u533a\u95f4\u9650, 10.2%];\u00a0P<\/em>\u2009=\u2009.84)\u3002\u6c28\u7532\u73af\u9178\u7ec4\u4e0e\u5b89\u6170\u5242\u7ec428\u5929\u75c5\u6b7b\u7387(14% vs 17%; \u5dee\u5f02, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26)\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206(6.8 vs 7.6; \u5dee\u5f02, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29)\uff0c\u6216\u9885\u5185\u51fa\u8840\u8fdb\u5c55 (16% vs 20%; \u5dee\u5f02, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16)\u5747\u65e0\u663e\u8457\u5dee\u5f02\u3002<\/p>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong> \u7ed3\u8bba\u4e0e\u610f\u4e49<\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
\u5bf9\u4e8e\u4e2d\u91cd\u5ea6TBI\u60a3\u8005\uff0c\u521b\u4f24\u540e\u9662\u5916\u4f7f\u7528\u6c28\u7532\u73af\u9178\u4e0d\u80fd\u663e\u8457\u6539\u5584\u6269\u5c55\u683c\u62c9\u65af\u54e5\u9884\u540e\u8bc4\u5206\u6d4b\u5b9a\u76846\u4e2a\u6708\u795e\u7ecf\u7cfb\u7edf\u9884\u540e\u3002<\/p>\n\n\n\n
Trial Registration<\/strong>\u00a0\u8bd5\u9a8c\u6ce8\u518c<\/h3>\n\n\n\n
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.<\/p>\n\n\n\n
\u4e3b\u8981\u9884\u540e\u6307\u6807\u4e3a\u6c28\u7532\u73af\u9178\u8054\u5408\u7ec46\u4e2a\u6708\u65f6\u795e\u7ecf\u7cfb\u7edf\u529f\u80fd\uff08\u6269\u5c55\u683c\u62c9\u65af\u54e5\u7ed3\u5c40\u8bc4\u5206> 4\u5206[\u4e2d\u5ea6\u6b8b\u75be\u6216\u6062\u590d\u826f\u597d]\uff09\u4f18\u4e8e\u5b89\u6170\u5242\u7ec4\u3002\u975e\u5bf9\u79f0\u6027\u663e\u8457\u5dee\u5f02\u9608\u503c\u8bbe\u4e3a0.1\uff08\u83b7\u76ca\uff09\u53ca0.025\uff08\u6709\u5bb3\uff09\u3002\u5171\u670918\u9879\u6b21\u8981\u9884\u540e\u6307\u6807\uff0c\u672c\u6587\u62a5\u544a\u4e86\u5176\u4e2d\u76845\u9879\uff1a28\u5929\u75c5\u6b7b\u7387\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206\uff08\u8303\u56f40 [\u65e0\u4f24\u6b8b]\u81f330 [\u6b7b\u4ea1]\uff0c\u9885\u5185\u51fa\u8840\u8fdb\u5c55\uff0c\u766b\u75eb\u53d1\u751f\u7387\uff0c\u4ee5\u53ca\u8840\u6813\u6813\u585e\u4e8b\u4ef6\u53d1\u751f\u7387\uff09\u3002<\/p>\n\n\n\n
Results<\/strong>\u00a0\u7ed3\u679c<\/h3>\n\n\n\nAmong 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, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [97.5% 1-sided confidence limit for harm, 10.2%];\u00a0P<\/em>\u2009=\u2009.84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29), or progression of intracranial hemorrhage (16% vs 20%; difference, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16).<\/p>\n\n\n\n\u7814\u7a76\u5165\u90091063\u540d\u60a3\u8005\uff0c\u5176\u4e2d96\u540d\u968f\u673a\u5206\u7ec4\u60a3\u8005\u672a\u4f7f\u7528\u7814\u7a76\u836f\u7269\uff0c1\u540d\u60a3\u8005\u88ab\u6392\u9664\uff0c\u6700\u7ec8966\u540d\u60a3\u8005\u7eb3\u5165\u5206\u6790(\u5e73\u5747\u5e74\u9f84, 42\u5c81; 255\u540d [74%] \u7537\u6027; \u5e73\u5747GCS\u8bc4\u5206, 8)\u3002\u6240\u6709\u60a3\u8005\u4e2d\uff0c819\u540d (84.8%) \u60a3\u80056\u4e2a\u6708\u968f\u8bbf\u7684\u4e3b\u8981\u9884\u540e\u5206\u6790\u6570\u636e\u9f50\u5168\u3002\u6c28\u7532\u73af\u9178\u7ec465%\u7684\u60a3\u8005\u548c\u5b89\u6170\u5242\u7ec462%\u7684\u60a3\u8005\u53d1\u751f\u4e3b\u8981\u9884\u540e (\u5dee\u5f02, 3.5%; [\u83b7\u76ca\u768490% \u5355\u5c3e\u533a\u95f4\u9650, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [\u6709\u5bb3\u768497.5% \u5355\u5c3e\u533a\u95f4\u9650, 10.2%];\u00a0P<\/em>\u2009=\u2009.84)\u3002\u6c28\u7532\u73af\u9178\u7ec4\u4e0e\u5b89\u6170\u5242\u7ec428\u5929\u75c5\u6b7b\u7387(14% vs 17%; \u5dee\u5f02, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26)\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206(6.8 vs 7.6; \u5dee\u5f02, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29)\uff0c\u6216\u9885\u5185\u51fa\u8840\u8fdb\u5c55 (16% vs 20%; \u5dee\u5f02, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16)\u5747\u65e0\u663e\u8457\u5dee\u5f02\u3002<\/p>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong> \u7ed3\u8bba\u4e0e\u610f\u4e49<\/h3>\n\n\n\nAmong 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.<\/p>\n\n\n\n
\u5bf9\u4e8e\u4e2d\u91cd\u5ea6TBI\u60a3\u8005\uff0c\u521b\u4f24\u540e\u9662\u5916\u4f7f\u7528\u6c28\u7532\u73af\u9178\u4e0d\u80fd\u663e\u8457\u6539\u5584\u6269\u5c55\u683c\u62c9\u65af\u54e5\u9884\u540e\u8bc4\u5206\u6d4b\u5b9a\u76846\u4e2a\u6708\u795e\u7ecf\u7cfb\u7edf\u9884\u540e\u3002<\/p>\n\n\n\n
Trial Registration<\/strong>\u00a0\u8bd5\u9a8c\u6ce8\u518c<\/h3>\n\n\n\n
\u7814\u7a76\u5165\u90091063\u540d\u60a3\u8005\uff0c\u5176\u4e2d96\u540d\u968f\u673a\u5206\u7ec4\u60a3\u8005\u672a\u4f7f\u7528\u7814\u7a76\u836f\u7269\uff0c1\u540d\u60a3\u8005\u88ab\u6392\u9664\uff0c\u6700\u7ec8966\u540d\u60a3\u8005\u7eb3\u5165\u5206\u6790(\u5e73\u5747\u5e74\u9f84, 42\u5c81; 255\u540d [74%] \u7537\u6027; \u5e73\u5747GCS\u8bc4\u5206, 8)\u3002\u6240\u6709\u60a3\u8005\u4e2d\uff0c819\u540d (84.8%) \u60a3\u80056\u4e2a\u6708\u968f\u8bbf\u7684\u4e3b\u8981\u9884\u540e\u5206\u6790\u6570\u636e\u9f50\u5168\u3002\u6c28\u7532\u73af\u9178\u7ec465%\u7684\u60a3\u8005\u548c\u5b89\u6170\u5242\u7ec462%\u7684\u60a3\u8005\u53d1\u751f\u4e3b\u8981\u9884\u540e (\u5dee\u5f02, 3.5%; [\u83b7\u76ca\u768490% \u5355\u5c3e\u533a\u95f4\u9650, \u22120.9%];\u00a0P<\/em>\u2009=\u2009.16; [\u6709\u5bb3\u768497.5% \u5355\u5c3e\u533a\u95f4\u9650, 10.2%];\u00a0P<\/em>\u2009=\u2009.84)\u3002\u6c28\u7532\u73af\u9178\u7ec4\u4e0e\u5b89\u6170\u5242\u7ec428\u5929\u75c5\u6b7b\u7387(14% vs 17%; \u5dee\u5f02, \u22122.9% [95% CI, \u22127.9% to 2.1%];\u00a0P<\/em>\u2009=\u2009.26)\uff0c6\u4e2a\u6708\u4f24\u6b8b\u8bc4\u5b9a\u91cf\u8868\u8bc4\u5206(6.8 vs 7.6; \u5dee\u5f02, \u22120.9 [95% CI, \u22122.5 to 0.7];\u00a0P<\/em>\u2009=\u2009.29)\uff0c\u6216\u9885\u5185\u51fa\u8840\u8fdb\u5c55 (16% vs 20%; \u5dee\u5f02, \u22125.4% [95% CI, \u221212.8% to 2.1%];\u00a0P<\/em>\u2009=\u2009.16)\u5747\u65e0\u663e\u8457\u5dee\u5f02\u3002<\/p>\n\n\n\n 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.<\/p>\n\n\n\n \u5bf9\u4e8e\u4e2d\u91cd\u5ea6TBI\u60a3\u8005\uff0c\u521b\u4f24\u540e\u9662\u5916\u4f7f\u7528\u6c28\u7532\u73af\u9178\u4e0d\u80fd\u663e\u8457\u6539\u5584\u6269\u5c55\u683c\u62c9\u65af\u54e5\u9884\u540e\u8bc4\u5206\u6d4b\u5b9a\u76846\u4e2a\u6708\u795e\u7ecf\u7cfb\u7edf\u9884\u540e\u3002<\/p>\n\n\n\n<\/figure>\n\n\n\nConclusions and Relevance<\/strong> \u7ed3\u8bba\u4e0e\u610f\u4e49<\/h3>\n\n\n\n
Trial Registration<\/strong>\u00a0\u8bd5\u9a8c\u6ce8\u518c<\/h3>\n\n\n\n