A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy.
A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy.
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DOI：
10.1056/nejmoa0801187
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发表时间：
2008-08-28
期刊：
影响因子：
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通讯作者：
Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network
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文献类型：
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作者：
Rouse DJ;Hirtz DG;Thom E;Varner MW;Spong CY;Mercer BM;Iams JD;Wapner RJ;Sorokin Y;Alexander JM;Harper M;Thorp JM Jr;Ramin SM;Malone FD;Carpenter M;Miodovnik M;Moawad A;O'Sullivan MJ;Peaceman AM;Hankins GD;Langer O;Caritis SN;Roberts JM;Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network
研究表明，早产前胎儿接触硫酸镁可能会降低脑瘫的风险。在这项多中心、安慰剂对照、双盲试验中，我们将妊娠24至31周之间有分娩危险的妇女随机分配接受硫酸镁，静脉推注6 g，随后每小时恒定输注2 g，或匹配安慰剂。主要结局是死胎或矫正年龄1岁时婴儿死亡或矫正年龄2岁或2岁以上中度或重度脑瘫的复合终点。共有2241名女性接受了随机分组。两组的基线特征相似。对95.6%的儿童进行了随访。硫酸镁组和安慰剂组的主要结局发生率无显著差异（分别为11.3%和11.7%;相对风险为0.97; 95%置信区间[CI]为0.77 - 1.23）。然而，在预先规定的次要分析中，硫酸镁组中中度或重度脑瘫的发生率显著较低（1.9% vs. 3.5%;相对风险，0.55; 95%CI，0.32 - 0.95）。两组之间的死亡风险无显著差异（9.5% vs. 8.5%;相对风险，1.12; 95% CI，0.85 - 1.47）。没有女性发生危及生命的事件。在预期的早期早产前，胎儿暴露于硫酸镁并不能降低中度或重度脑瘫或死亡的综合风险，尽管幸存者中脑瘫的发生率降低了。（ClinicalTrials.gov编号，NCT 00014989。）
Research suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy. In this multicenter, placebo-controlled, double-blind trial, we randomly assigned women at imminent risk for delivery between 24 and 31 weeks of gestation to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour, or matching placebo. The primary outcome was the composite of stillbirth or infant death by 1 year of corrected age or moderate or severe cerebral palsy at or beyond 2 years of corrected age. A total of 2241 women underwent randomization. The baseline characteristics were similar in the two groups. Follow-up was achieved for 95.6% of the children. The rate of the primary outcome was not significantly different in the magnesium sulfate group and the placebo group (11.3% and 11.7%, respectively; relative risk, 0.97; 95% confidence interval [CI], 0.77 to 1.23). However, in a prespecified secondary analysis, moderate or severe cerebral palsy occurred significantly less frequently in the magnesium sulfate group (1.9% vs. 3.5%; relative risk, 0.55; 95% CI, 0.32 to 0.95). The risk of death did not differ significantly between the groups (9.5% vs. 8.5%; relative risk, 1.12; 95% CI, 0.85 to 1.47). No woman had a life-threatening event. Fetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate or severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. (ClinicalTrials.gov number, NCT00014989.)