Saver Jeffrey L., Starkman Sidney
UCLA Stroke Center and Department of Neurology, University of California, Los Angeles, CA 90095, USA.
Stroke is the second leading cause of death and a leading cause of disability worldwide. Unfortunately, current therapies for acute ischemic stroke are of extremely limited effectiveness. The ideal neuro- protective agent for stroke would be inexpensive, readily available, easy to administer and have no significant adverse side effects. Intravenous magnesium sulphate offers promise as just such an agent. In clinical trials to date, administration of magnesium sulphate has shown favourable trends toward neuroprotection in resuscitated cardiac arrest patients, in cardiac bypass surgery and carotid endarterectomy. In acute stroke, eight pilot clinical trials of magnesium sulphate have shown good safety, and the subset of pilot trials with randomized controls have shown favourable effects on clinical outcome point estimates. The first phase 3 trial of magnesium sulphate for focal stroke was the Intravenous Magnesium Efficacy in Stroke (IMAGES) Trial. Hampered by late administration of the study agent, IMAGES overall produced a neutral result, but exploratory analyses identified early (under 3 hour), lacunar stroke, haemorrhagic stroke, and severely hypertensive patients as having a potential differential beneficial response to magnesium that deserved further investigation. The Field Administration of Stroke Therapy – Magnesium (FAST-MAG) trial has been specifically designed to test magnesium in the hyperacute time window by initiating therapy in the prehospital setting.
中风是全球第二大致死原因和主要致残原因。不幸的是,目前用于急性缺血性中风的治疗方法效果极为有限。理想的中风神经保护剂应价格低廉、易于获得、易于给药且无明显不良副作用。静脉注射硫酸镁有望成为这样一种药物。在迄今为止的临床试验中,硫酸镁给药在心肺复苏患者、心脏搭桥手术和颈动脉内膜切除术中已显示出对神经保护的有利趋势。在急性中风方面,八项硫酸镁的试点临床试验显示出良好的安全性,而带有随机对照的试点试验子集已显示出对临床结局点估计有有利影响。硫酸镁用于局灶性中风的第一项3期试验是中风静脉注射镁疗效(IMAGES)试验。由于研究药物给药较晚,IMAGES总体产生了中性结果,但探索性分析确定早期(3小时以内)、腔隙性中风、出血性中风和严重高血压患者对镁可能有不同的有益反应,值得进一步研究。中风治疗镁现场给药(FAST-MAG)试验专门设计用于在超急性期通过在院前环境中启动治疗来测试镁。