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急性脑卒中院前使用神经保护剂硫酸镁
Prehospital Use of Magnesium Sulfate as Neuroprotection in Acute Stroke


Jeffrey L. Saver ... 心脑血管疾病 • 2015.02.05

摘要


背景

硫酸镁在脑卒中的临床前模型中具有神经保护作用,对早期脑卒中患者给予硫酸镁已显示出潜在的有效性以及可接受的安全性。然而神经保护剂的延迟使用阻碍了早期的神经保护剂三期试验。

 

方法

我们将疑似脑卒中的患者进行随机分配,在症状发生后2小时内分别接受硫酸镁或安慰剂的静脉内输入。在患者到达医院之前医助人员即启动治疗——给予输入负荷剂量,在患者到达医院后继续24小时维持输液。主要终点是发病90天时的残疾程度,通过改良的Rankin量表评分,范围0~6分,分数越高提示残疾越重)评定。

 

结果

本研究共入组1,700例患者(硫酸镁组857例,安慰剂组843例),平均年龄(±标准差)为69±13岁,42.6%为女性,治疗前基于洛杉矶运动量表的脑卒中严重程度评分(得分范围0~10分,分数越高运动障碍越严重)为3.7±1.3分。符合要求的病例中73.3%最终诊断为脑缺血,22.8%为颅内出血,3.9%为类似脑卒中症状疾病。患者明确无卒中症状和研究药物开始输注间的中位间隔时间为45分钟(四分位范围为35~62),74.3%的患者在出现症状1小时内即进行研究药物的输注。以总体改良的Rankin量表评定的90天残疾结局分布在硫酸镁组和安慰剂组中并无明显偏差(P=0.28,经Cochran-Mantel-Haenszel检测);两组间平均得分(平均为2.7分,P=1.00)无显著差异;两组在死亡率(试验组15.4%,安慰剂组15.5%,P=0.95)及所有严重不良事件方面同样无显著差异。

 

结论

硫酸镁的院前给药是安全的,脑卒中症状发作2小时内便可接受硫酸镁治疗,但该药并未改善脑卒中的90天伤残结局(该实验由美国国立神经病和卒中研究所资助;FAST-MAG在ClinicalTrials.gov注册号为NCT00059332)。





作者信息

Jeffrey L. Saver, M.D., Sidney Starkman, M.D., Marc Eckstein, M.D., Samuel J. Stratton, M.D., Franklin D. Pratt, M.D., M.P.H.T.M., Scott Hamilton, Ph.D., Robin Conwit, M.D., David S. Liebeskind, M.D., Gene Sung, M.D., Ian Kramer, M.D., Gary Moreau, M.D., Robert Goldweber, M.D., and Nerses Sanossian, M.D., for the FAST-MAG Investigators and Coordinators*
From the Comprehensive Stroke Center (J.L.S., S.S., D.S.L.) and the Departments of Neurology (J.L.S., S.S., D.S.L.) and Emergency Medicine (S.S., F.P.), David Geffen School of Medicine at the University of California, Los Angeles (UCLA), the Departments of Emergency Medicine (M.E.) and Neurology (G.S., N.S.), Keck School of Medicine of the University of Southern California, the Los Angeles Fire Department (M.E.), the Los Angeles County Fire Department (F.P.), the Department of Emergency Medicine, Presbyterian Intercommunity Hospital (I.K.), the Department of Emergency Medicine, Long Beach Memorial Medical Center (G.M.), and the Department of Emergency Medicine, Huntington Memorial Hospital (R.G.), Los Angeles, the Los Angeles County Emergency Medical Services (EMS) Agency, the Orange County EMS Agency, and the Department of Emergency Medicine, Harbor–UCLA Medical Center, Torrance (S.J.S.), and Stanford University, Palo Alto (S.H.) — all in California; and the National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.). Address reprint requests to Dr. Saver at the UCLA Comprehensive Stroke Center, 710 Westwood Plaza, Los Angeles, CA 90095, or at jsaver@mednet.ucla.edu. *A complete list of investigators in the Field Administration of Stroke Therapy–Magnesium (FAST-MAG) phase 3 trial is provided in the Supplementary Appendix, available at NEJM.org.

 

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