Magnesium sulfate for neuroprotection after traumatic brain injury: a randomised controlled trial
Magnesium sulfate for neuroprotection after traumatic brain injury: a randomised controlled trial
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DOI：
10.1016/s1474-4422(06)70630-5
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发表时间：
2007-01-01
期刊：
影响因子：
48
通讯作者：
Dikmen, Sureyya S.
中科院分区：
文献类型：
--
作者：
Temkin, Nancy R.;D Anderson, Gail;Dikmen, Sureyya S.
背景创伤性脑损伤是一个重要的和昂贵的健康问题。补充镁积极影响创伤性脑损伤后继发性损伤的许多过程，并持续改善动物模型的结果。我们的目的是测试是否与镁治疗有利的影响结果在头部受伤patients.Methods在一项双盲试验，499名患者年龄在14岁或以上承认的一级区域创伤中心之间，1998年8月和2004年10月，中度或重度创伤性脑损伤患者在受伤后8小时内随机分配两种剂量的镁或安慰剂，并持续5天镁剂量的目标是达到1.0-1.85 mmol/L或1.25-2.5 mmol/L的血清镁范围。主要结局是死亡率、癫痫发作、功能测量和损伤后6个月内评估的神经心理学测试的复合终点。根据意向治疗原则进行分析。该试验在ClinicalTrials.gov注册，编号NCT 00004730。结果镁在较高剂量下对复合主要结局指标无显著积极影响（镁组平均百分位数为55，安慰剂组为52，95%CI差异为-7至14; p=0.70）。那些随机分配的镁剂量较低的患者比那些分配安慰剂的患者明显更差（48 vs 54，95% CI -10.5 to -2; p=0.007）。此外，较高镁剂量的死亡率高于安慰剂。除低镁目标组中肺水肿和呼吸衰竭轻微过量外，两组之间的其他主要医学并发症相似。没有亚组中确定镁有显着的积极作用。解释连续输注镁5天内给予患者8小时内的中度或重度创伤性脑损伤不具有神经保护作用，甚至可能有负面影响，在治疗显着的头部损伤。
Background Traumatic brain injuries represent an important and costly health problem. Supplemental magnesium positively affects many of the processes involved in secondary injury after traumatic brain injury and consistently improves outcome in animal models. We aimed to test whether treatment with magnesium favourably affects outcome in head-injured patients.Methods In a double-blind trial, 499 patients aged 14 years or older admitted to a level 1 regional trauma Centre between August, 1998, and October, 2004, with moderate or severe traumatic brain injury were randomly assigned one of two doses of magnesium or placebo within 8 h of injury and continuing for 5 days. Magnesium doses were targeted to achieve serum magnesium ranges of 1.0-1.85 mmol/L or 1.25-2.5 mmol/L. The primary outcome was a composite of mortality, seizures, functional measures, and neuropsychological tests assessed up to 6 months after injury. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT00004730.Findings Magnesium showed no significant positive effect on the composite primary outcome measure at the higher dose (mean=55 average percentile ranking on magnesium vs 52 on placebo, 95% CI for difference -7 to 14; p=0.70). Those randomly assigned magnesium at the lower dose did significantly worse than those assigned placebo (48 vs 54, 95% CI -10.5 to -2; p=0.007). Furthermore, there was higher mortality with the higher magnesium dose than with placebo. Other major medical complications were similar between groups, except for a slight excess of pulmonary oedema and respiratory failure in the lower magnesium target group. No subgroups were identified in which magnesium had a significantly positive effect.Interpretation Continuous infusions of magnesium for 5 days given to patients within 8 h of moderate or severe traumatic brain injury were not neuroprotective and might even have a negative effect in the treatment of significant head injury.