Effect of magnesium sulfate given for neuroprotection before preterm birth - A randomized controlled trial
Effect of magnesium sulfate given for neuroprotection before preterm birth - A randomized controlled trial
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DOI：
10.1001/jama.290.20.2669
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发表时间：
2003-11-26
影响因子：
120.7
通讯作者：
Haslam, RR
中科院分区：
文献类型：
--
作者：
Crowther, CA;Hiller, JE;Haslam, RR
背景 产前硫酸镁可能会降低极早产儿脑瘫或死亡的风险。目的 确定对妊娠 30 周前有早产风险的妇女给予硫酸镁进行神经保护，预防儿科死亡和脑瘫的有效性。设计、设置和患者 在澳大利亚和新西兰 16 家三级医院进行的随机对照试验，按中心和多胎妊娠分层。 1996 年 2 月至 2000 年 9 月期间，共有 1062 名胎龄小于 30 周、计划或预计在 24 小时内分娩的妇女入组，并对校正年龄为 2 岁的存活儿童进行随访。 干预措施 妇女被随机分配接受 8 mL 负荷输注（4 g [16 mmol] 0.5 g/mL 硫酸镁溶液或等渗氯化钠溶液） [0.9%]) 20 分钟，然后以 2 mL/h 的维持输注长达 24 小时。 主要结果指标 儿童总死亡率、脑瘫发生率以及校正年龄 2 岁时死亡或脑瘫的综合结果。 结果 对 1047 名 (99%) 2 年幸存者进行了数据分析。儿科总死亡率（13.8% vs 17.1%；相对风险 [RR]，0.83；95% 置信区间 [CI]，0.64-1.09）、幸存者脑瘫（6.8% vs 8.2%；RR，0.83；95% CI，0.54-1.27）以及合并死亡或脑瘫（19.8% vs 24.0%；RR，0.83；95% CI，0.66-1.03）接触硫酸镁的婴儿发生率较低，但差异无统计学意义。镁组中显着的粗大运动功能障碍（3.4% vs 6.6%；RR，0.51；95% CI，0.29-0.91）以及合并死亡或显着的粗大运动功能障碍（17.0% vs 22.7%；RR，0.75；95% CI，0.59-0.96）显着降低。 结论 早产前妇女服用硫酸镁可能会改善重要的儿科结局。没有发现严重的有害影响。
Context Prenatal magnesium sulfate may reduce the risk of cerebral palsy or death in very preterm infants.Objective To determine the effectiveness of magnesium sulfate given for neuroprotection to women at risk of preterm birth before 30 weeks' gestation in preventing pediatric mortality and cerebral palsy.Design, Setting, and Patients Randomized controlled trial at 16 tertiary hospitals in Australia and New Zealand with stratification by center and multiple pregnancy. A total of 1062 women with fetuses younger than 30 weeks' gestation for whom birth was planned or expected within 24 hours were enrolled from February 1996 to September 2000 with follow-up of surviving children at a corrected age of 2 years.Interventions Women were randomly assigned to receive a loading infusion of 8 mL (4 g [16 mmol] of 0.5 g/mL of magnesium sulfate solution or isotonic sodium chloride solution [0.9%]) for 20 minutes followed by a maintenance infusion of 2 mL/h for up to 24 hours.Main Outcome Measures Rates of total-pediatric mortality, cerebral palsy, and the combined outcome of death or cerebral palsy at a corrected age of 2 years.Results Data were analyzed for 1047 (99%) 2-year survivors. Total pediatric mortality (13.8% Vs 17.1%; relative risk [RR], 0.83; 95% confidence interval [CI], 0.64-1.09), cerebral palsy in survivors (6.8% vs 8.2%; RR, 0.83; 95% CI, 0.54-1.27), and combined death or cerebral palsy (19.8% Vs 24.0%; RR, 0.83; 95% CI, 0.66-1.03) were less frequent for infants exposed to magnesium sulfate, but none of the differences were statistically significant. Substantial gross motor dysfunction (3.4% vs 6.6%; RR, 0.51; 95% CI, 0.29-0.91) and combined death or substantial gross motor dysfunction (17.0% Vs 22.7%; RR, 0.75; 95% CI, 0.59-0.96) were significantly reduced in the magnesium group.Conclusions Magnesium sulfate given to women immediately before very preterm birth may improve important pediatric outcomes. No serious harmful effects were seen.