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【medical-news】一项随机对照试验显示：硫酸镁对
Summary
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.
http://www.thelancet.com/journals/laneur/article/PIIS1474442206706305/abstract 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Magnesium sulfate for neuroprotection after traumatic brain injury: a randomised controlled trial
一项探讨硫酸镁对脑外伤是否具有神经保护作用的随机对照研究
Summary
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.
概要：
背景：
脑外伤是严重且治疗费用高昂的病症。补充镁对脑外伤后的二次打击的诸多阶段有积极作用且疗效已在动物模型中得到证实。我们的研究目的在于探讨镁对脑外伤病人是否有积极作用。
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.
方法：
采用双盲试验，将1998年8月至2004年10月间收住入level 1 regional trauma centre 的499位年龄大于等于14岁的中重度脑外伤病人，随机分配到处理组和对照组，在伤后8小时内分别给予一剂镁（分高剂量和低剂量两种）和安慰剂，并连续使用5天。低剂量处理组血镁浓度控制在1.0–1.85 mmol/L的范围内，高剂量则为1.25–2.5 mmol/L。主要疗效指标综合考虑死亡率、癫痫发作情况、功能检测以及伤后为期6个月的神经心理测试。该分析按照意向性分析（Intention-to-treat，ITT）原则。该试验在Clinicaltrials.gov数据库系统的注册号为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.
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作者:admin@医学,生命科学 2011-04-02 05:11
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