ProTECT: A randomized clinical trial of progesterone for acute traumatic brain injury
ProTECT: A randomized clinical trial of progesterone for acute traumatic brain injury
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DOI：
10.1016/j.annemergmed.2006.07.932
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发表时间：
2007-04-01
影响因子：
6.2
通讯作者：
Stein, Donald G.
中科院分区：
文献类型：
--
作者：
Wright, David W.;Kellermann, Arthur L.;Stein, Donald G.
研究目的：实验室证据表明孕酮具有有效的神经保护作用。我们进行了一项试点临床试验，以评估管理孕激素的安全性和潜在的好处，急性创伤性脑injury.Methods：这第二阶段，随机，双盲，安慰剂对照试验进行了一个城市I级创伤中心。100名成年创伤患者在受伤后11小时内到达，复苏后格拉斯哥昏迷量表评分为4至12分，并获得代理同意。受试者以4：1的比例随机接受静脉注射黄体酮或安慰剂。设盲观察员每天评估患者的不良事件发生率和恢复迹象。伤后30天评估神经功能结局。主要安全性指标是不良事件发生率和30天死亡率的差异。受益的主要措施是二分的格拉斯哥结局量表扩展30 days postinjuries.Results：77例患者接受黄体酮; 23例接受安慰剂。两组具有相似的人口统计学和临床特征。实验室和生理特征在入组时和整个治疗期间相似。没有严重的不良事件归因于孕酮。两组的不良和严重不良事件发生率相似，但随机分配至孕酮组的患者30天死亡率低于对照组（率比0.43; 95%置信区间0.18至0.99）。伤后30天，两组中大多数严重创伤性脑损伤幸存者的格拉斯哥结局量表扩展和残疾评定量表评分相对较差。然而，中度创伤性脑损伤的幸存者谁收到黄体酮更有可能有一个中度至良好的结果比那些随机安慰剂。结论：在这个小的研究，黄体酮没有造成明显的伤害，并显示出可能的迹象，受益。
Study objective: Laboratory evidence indicates that progesterone has potent neuroprotective effects. We conducted a pilot clinical trial to assess the safety and potential benefit of administering progesterone to patients with acute traumatic brain injury.Methods: This phase II, randomized, double-blind, placebo-controlled trial was conducted at an urban Level I trauma center. One hundred adult trauma patients who arrived within 11 hours of injury with a postresuscitation Glasgow Coma Scale score of 4 to 12 were enrolled with proxy consent. Subjects were randomized on a 4:1 basis to receive either intravenous progesterone or placebo. Blinded observers assessed patients daily for the occurrence of adverse events and signs of recovery. Neurologic outcome was assessed 30 days postinjury. The primary safety measures were differences in adverse event rates and 30-day mortality. The primary measure of benefit was the dichotomized Glasgow Outcome Scale-Extended 30 days postinjury.Results: Seventy-seven patients received progesterone; 23 received placebo. The groups had similar demographic and clinical characteristics. Laboratory and physiologic characteristics were similar at enrollment and throughout treatment. No serious adverse events were attributed to progesterone. Adverse and serious adverse event rates were similar in both groups, except that patients randomized to progesterone had a lower 30-day mortality rate than controls (rate ratio 0.43; 95% confidence interval 0.18 to 0.99). Thirty days postinjury, the majority of severe traumatic brain injury survivors in both groups had relatively poor Glasgow Outcome Scale-Extended and Disability Rating Scale scores. However, moderate traumatic brain injury survivors who received progesterone were more likely to have a moderate to good outcome than those randomized to placebo.Conclusion: In this small study, progesterone caused no discernible harm and showed possible signs of benefit.