创伤性脑损伤中的孕酮：是时候进入III期试验了。
Progesterone in traumatic brain injury: time to move on to phase III trials.
作者信息
Vandromme Marianne, Melton Sherry M, Kerby Jeffrey D
机构信息
Section of Trauma, Burns, and Surgical Critical Care, Department of Surgery, University of Alabama at Birmingham, 19th Street South, Birmingham, Alabama 35294, USA.
出版信息
Crit Care. 2008;12(3):153. doi: 10.1186/cc6899. Epub 2008 May 29.
There are several candidate neuroprotective agents that have been shown in preclinical testing to improve outcomes following traumatic brain injury (TBI). Xiao and colleagues have performed an in hospital, double blind, randomized, controlled clinical trial utilizing progesterone in the treatment of patients sustaining TBI evaluating safety and long term clinical outcomes. These data, combined with the results of the previously published ProTECT trial, show progesterone to be safe and potentially efficacious in the treatment of TBI. Larger phase III trials will be necessary to verify results prior to clinical implementation. Clinical trials networks devoted to the study of TBI are vital to the timely clinical testing of these candidate agents and need to be supported.
有几种候选神经保护剂在临床前试验中已显示可改善创伤性脑损伤（TBI）后的预后。肖及其同事进行了一项住院双盲随机对照临床试验，使用孕酮治疗TBI患者，评估安全性和长期临床预后。这些数据与先前发表的ProTECT试验结果相结合，表明孕酮在治疗TBI方面是安全且可能有效的。在临床应用之前，需要进行更大规模的III期试验来验证结果。致力于TBI研究的临床试验网络对于这些候选药物的及时临床测试至关重要，需要得到支持。
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