产前使用硫酸镁预防早产儿脑瘫：一项双盲、随机、安慰剂对照、多中心试验
【目的】
评价产前硫酸镁预防早产儿脑瘫的疗效，在一定程度上同时为关联试验序列分析（linked trial sequential analysis）提供适当效能。
【设计】
双盲、随机、安慰剂对照、多中心试验。
【处所】
丹麦14家产科。
【人群】
自2011年12月至2018年1月，共有560名孕32周前有早产风险的孕妇纳入随机试验。这些孕妇共娩出680名新生儿。
【方法】
孕妇随机接受5g首剂联合1g/小时维持剂量硫酸镁和同等容量的安慰剂。，通过回顾医学病例和填写年龄和阶段问卷（Ages and Stages Questionnaire）随访出生儿童至≥校正18月龄。
【主要测量结局】
主要结局为中-重度脑瘫。次要结局包括死亡率，新生儿发病率，失明和轻度脑瘫。
【结果】
中-重度脑瘫在硫酸镁组和安慰剂组的粗率分别为2.0%和3.3%。硫酸镁组中-重度脑瘫校正比值比低于安慰剂组（OR 0.61；95%CI 0.23-1.65）。
【结论】
孕32周前硫酸镁使用能够降低早产儿中-重度脑瘫可能性，这一结果完全与其他利用关联试验序列分析总结的随机试验证据一致。
Antenatal magnesium sulphate for the prevention of cerebral palsy ininfants born preterm: a double‐blind, randomised, placebo‐controlled,multi‐centre trial
HanneTrap Wolf ，JesperBrok ，TineBrink Henriksen ，GormGreisen ，JannieDalby Salvig
OlePryds ，MortenHedegaard ，TomWeber ，HanneKristine Hegaard… Seeall authors
First published:01 April 2020
https://doi.org/10.1111/1471-0528.16239
【Objective】
To study the effect of antenatal magnesiumsulphate (MgSO4) on cerebral palsy (CP) in a manner that also provides adequatepower for a linked trial sequential analysis.
【Design】
Double‐blind, randomised,placebo‐controlled, multicentre trial.
【Setting】
Fourteen Danish obstetric departments.
【Population】
In total, 560 pregnant women at risk forpreterm delivery before 32 weeks of gestation were randomised from December2011 to January 2018. Those women gave birth to 680 children.
【Methods】
Women were randomised to receiveeither a loading dose of 5 grams MgSO4followed by 1 gram/hour or a placebo inidentical volumes. The children were followed up at a corrected age of 18months or older with a review of their medical charts and with the Ages andStages Questionnaire.
【Main Outcome Measure】
The primary outcome measure was moderate tosevere CP. Secondary outcomes included mortality, neonatal morbidity, blindness,and mild CP.
【Results】
The crude rates of moderate to severe CP inthe MgSO4 group and the placebo group were 2.0% and 3.3%, respectively.The adjusted odds of moderate to severe CP were lower in the MgSO4 groupthan in the placebo group (odds ratio 0.61; 95% confidence interval 0.23‐1.65).
【Conclusions】
Antenatal MgSO4 before 32 weeks ofgestation decreases the likelihood of moderate to severe CP, and these resultsare entirely consistent with other randomised evidence summarised in the linkedtrial sequential analysis.
（编译 王伟琳）
