Gaab M R, Dietz H
Neurochirurgische Klinik, Medizinische Hochschule Hannover.
Neurochirurgia (Stuttg). 1989 Jul;32(4):93-100. doi: 10.1055/s-2008-1054013.
In spite of 20 years of discussion the value of corticosteroids in the therapy of head injury still remains controversial. Most animal experiments show an improvement of edema parameters with dexamethasone given immediately after trauma; pharmacological data suggest a further increased "ultrahigh" dosage compared to so-called "high" doses up to now. Simultaneously, the treatment duration might be reduced to 48-72 h after injury. The clinical studies available are not satisfying due to low numbers of patients, insufficient trauma classification and restriction to most severe brain injuries, and do not allow a definite answer. Little side effects and risks, however, were found with clinical steroid trials so far. We therefore perform a new multicenter trial with dexamethasone after head injury, whose design is presented: A sufficient number of patients (n greater than = 240) is recruited according to a priori defined criteria for statistical evaluation. Treatment starts with ultrahigh dosage of 500 mg dexamethasone (Fortecortin) initially not later than 3 h after injury, the treatment duration is limited to 51 h. The selection of patients is based on restrictive criteria of inclusion and exclusion, the age of patients ranges from 15 to 55 years. For maximal statistical separation and for reduction of disturbing factors the representativity of trauma patients is intentionally neglected.
尽管经过了20年的讨论，但皮质类固醇在治疗头部损伤中的价值仍然存在争议。大多数动物实验表明，创伤后立即给予地塞米松可改善水肿参数；药理学数据表明，与目前所谓的“高剂量”相比，“超高”剂量可进一步增加。同时，损伤后的治疗时间可缩短至48 - 72小时。现有的临床研究由于患者数量少、创伤分类不足以及仅限于最严重的脑损伤而不尽人意，无法给出明确答案。然而，到目前为止的临床类固醇试验发现副作用和风险很小。因此，我们进行了一项新的头部损伤后地塞米松多中心试验，其设计如下：根据事先定义的统计评估标准招募足够数量的患者（n≥240）。治疗从损伤后不迟于3小时开始给予500毫克地塞米松（氟替可的松）的超高剂量，治疗时间限制为51小时。患者的选择基于严格的纳入和排除标准，患者年龄在15至55岁之间。为了实现最大程度的统计区分并减少干扰因素，创伤患者的代表性被有意忽略。
