Clinical trials in head injury
Clinical trials in head injury
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DOI：
10.1089/089771502753754037
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发表时间：
2002-05-01
影响因子：
4.2
通讯作者：
Michel, ME
中科院分区：
文献类型：
--
作者：
Narayan, RK;Michel, ME
创伤性脑损伤(TBI)仍然是全球主要的公共卫生问题。在美国，闭合性头部损伤入院的发生率保守估计为每10万人中有200人，穿透性头部损伤的发生率估计为每10万人中有12人，是世界上任何发达国家中最高的。这就产生了每年大约500,000个新病例，其中相当大的比例显示出明显的长期残疾。不幸的是，针对这种疾病的有效治疗方法很少。由于各种原因，针对这种情况的临床试验很难设计和实施。尽管临床前数据前景看好，但近年来进行的大多数试验都未能证明结果有任何显著改善。这些失败的原因并不总是显而易见的，所获得的任何见解也并不总是被分享。因此，人们担心我们正在冒着重蹈覆辙的风险。认识到脑外伤的重要性，美国国家神经疾病和中风研究所(NINDS)主办了一次研讨会，来自临床、研究和制药背景的专家聚集在一起。这次研讨会被证明是非常有益的，并对以前和未来的TBI试验产生了许多见解。本文试图对研讨会提出的要点进行总结。希望这些经验教训将加强对这一重要研究领域未来工作的规划和设计。
Traumatic brain injury (TBI) remains a major public health problem globally. In the United States the incidence of closed head injuries admitted to hospitals is conservatively estimated to be 200 per 100,000 population, and the incidence of penetrating head injury is estimated to be 12 per 100,000, the highest of any developed country in the world. This yields an approximate number of 500,000 new cases each year, a sizeable proportion of which demonstrate signficant long-term disabilities. Unfortunately, there is a paucity of proven therapies for this disease. For a variety of reasons, clinical trials for this condition have been difficult to design and perform. Despite promising pre-clinical data, most of the trials that have been performed in recent years have failed to demonstrate any significant improvement in outcomes. The reasons for these failures have not always been apparent and any insights gained were not always shared. It was therefore feared that we were running the risk of repeating our mistakes. Recognizing the importance of TBI, the National Institute of Neurological Disorders and Stroke (NINDS) sponsored a workshop that brought together experts from clinical,, research, and pharmaceutical backgrounds. This workshop proved to be very informative and yielded many insights into previous and future TBI trials. This paper is an attempt to summarize the key points made at the workshop. It is hoped that these lessons will enhance the planning and design of future efforts in this important field of research.