Abstract：
OBJECTIVE: To review the evidence of the effects of neonatal magnesium sulphate for neuroprotection in perinatal asphyxia and hypoxic-ischaemic encephalopathy (HIE).
METHODS: This was a systematic review of randomized controlled trials (RCTs) (with meta-analysis) and non-RCTs assessing magnesium sulphate for treating perinatal asphyxia and HIE at 35 weeks or more gestation (primary outcomes: neonatal death and death or long-term major neurodevelopmental disability).
RESULTS: Twenty-five RCTs (2099 infants) and four non-RCTs (871 infants) were included, 23 in low- and middle-income countries (LMICs). In RCTs, reductions in neonatal death with magnesium sulphate versus placebo or no treatment (risk ratio [RR] = 0.68; 95% confidence interval [CI] = 0.53-0.86; 13 RCTs), and magnesium sulphate with melatonin versus melatonin alone (RR = 0.74; 95% CI = 0.58-0.95; one RCT) were observed. No difference in neonatal death was seen for magnesium sulphate with therapeutic hypothermia versus therapeutic hypothermia alone (RR = 0.66, 95% CI = 0.34-1.26; three RCTs), or magnesium sulphate versus phenobarbital (RR = 3.00; 95% CI = 0.86-10.46; one RCT). No reduction in death or long-term neurodevelopmental disability (RR = 0.52; 95% CI = 0.14-1.89; one RCT) but reductions in several short-term adverse outcomes were observed with magnesium sulphate. Evidence was low- to very-low certainty because of risk of bias and imprecision.
CONCLUSIONS: Given the uncertainty of the current evidence, further robust neonatal magnesium sulphate research is justified. This may include high-quality studies to determine stand-alone effects in LMICs and effects with and after therapeutic hypothermia in high-income countries.
METHODS: This was a systematic review of randomized controlled trials (RCTs) (with meta-analysis) and non-RCTs assessing magnesium sulphate for treating perinatal asphyxia and HIE at 35 weeks or more gestation (primary outcomes: neonatal death and death or long-term major neurodevelopmental disability).
RESULTS: Twenty-five RCTs (2099 infants) and four non-RCTs (871 infants) were included, 23 in low- and middle-income countries (LMICs). In RCTs, reductions in neonatal death with magnesium sulphate versus placebo or no treatment (risk ratio [RR] = 0.68; 95% confidence interval [CI] = 0.53-0.86; 13 RCTs), and magnesium sulphate with melatonin versus melatonin alone (RR = 0.74; 95% CI = 0.58-0.95; one RCT) were observed. No difference in neonatal death was seen for magnesium sulphate with therapeutic hypothermia versus therapeutic hypothermia alone (RR = 0.66, 95% CI = 0.34-1.26; three RCTs), or magnesium sulphate versus phenobarbital (RR = 3.00; 95% CI = 0.86-10.46; one RCT). No reduction in death or long-term neurodevelopmental disability (RR = 0.52; 95% CI = 0.14-1.89; one RCT) but reductions in several short-term adverse outcomes were observed with magnesium sulphate. Evidence was low- to very-low certainty because of risk of bias and imprecision.
CONCLUSIONS: Given the uncertainty of the current evidence, further robust neonatal magnesium sulphate research is justified. This may include high-quality studies to determine stand-alone effects in LMICs and effects with and after therapeutic hypothermia in high-income countries.
摘要：
目的：综述新生儿硫酸镁对围产期窒息和缺氧缺血性脑病(HIE)的神经保护作用。
方法：这是对评估硫酸镁治疗35周或以上妊娠围产期窒息和HIE的随机对照试验（RCT）（具有荟萃分析）和非RCT的系统评价（主要结局：新生儿死亡和死亡或长期严重神经发育障碍）。
结果：纳入了25个随机对照试验（2099名婴儿）和4个非随机对照试验（871名婴儿），23在低收入和中等收入国家(LMICs)。在RCT中,与安慰剂或不治疗相比，硫酸镁可减少新生儿死亡（风险比[RR]=0.68;95％置信区间[CI]=0.53-0.86;13项随机对照试验），观察到硫酸镁和褪黑素与单独的褪黑素（RR=0.74；95％CI=0.58-0.95；一次RCT）。硫酸镁治疗性低温与单纯治疗性低温相比，新生儿死亡无差异（RR=0.66，95％CI=0.34-1.26；三项随机对照试验），或硫酸镁与苯巴比妥（RR=3.00；95％CI=0.86-10.46；一次RCT）。硫酸镁没有减少死亡或长期神经发育障碍（RR=0.52；95％CI=0.14-1.89；一次RCT），但观察到几种短期不良结局的减少。由于存在偏见和不精确的风险，证据的确定性很低到很低。
结论：鉴于当前证据的不确定性，进一步强有力的新生儿硫酸镁研究是合理的。这可能包括高质量的研究，以确定LMICs中的独立效应以及高收入国家治疗性低温后的效应。
方法：这是对评估硫酸镁治疗35周或以上妊娠围产期窒息和HIE的随机对照试验（RCT）（具有荟萃分析）和非RCT的系统评价（主要结局：新生儿死亡和死亡或长期严重神经发育障碍）。
结果：纳入了25个随机对照试验（2099名婴儿）和4个非随机对照试验（871名婴儿），23在低收入和中等收入国家(LMICs)。在RCT中,与安慰剂或不治疗相比，硫酸镁可减少新生儿死亡（风险比[RR]=0.68;95％置信区间[CI]=0.53-0.86;13项随机对照试验），观察到硫酸镁和褪黑素与单独的褪黑素（RR=0.74；95％CI=0.58-0.95；一次RCT）。硫酸镁治疗性低温与单纯治疗性低温相比，新生儿死亡无差异（RR=0.66，95％CI=0.34-1.26；三项随机对照试验），或硫酸镁与苯巴比妥（RR=3.00；95％CI=0.86-10.46；一次RCT）。硫酸镁没有减少死亡或长期神经发育障碍（RR=0.52；95％CI=0.14-1.89；一次RCT），但观察到几种短期不良结局的减少。由于存在偏见和不精确的风险，证据的确定性很低到很低。
结论：鉴于当前证据的不确定性，进一步强有力的新生儿硫酸镁研究是合理的。这可能包括高质量的研究，以确定LMICs中的独立效应以及高收入国家治疗性低温后的效应。
