PDF(Pubmed)
Abstract：
OBJECTIVE: To systematically review the evidence for the effectiveness and safety of magnesium sulfate as a fetal neuroprotective agent when given to individuals at risk of preterm birth.
METHODS: We searched Cochrane Pregnancy and Childbirth\'s Trials Register, ClinicalTrials.gov , the World Health Organization International Clinical Trials Registry Platform (through March 17, 2023), and reference lists of relevant studies.
METHODS: Randomized controlled trials (RCTs) assessing magnesium sulfate for fetal neuroprotection in pregnant participants at risk of imminent preterm birth were eligible. Two authors assessed RCTs for inclusion, extracted data, and evaluated risk of bias, trustworthiness, and evidence certainty (GRADE [Grading of Recommendations Assessment, Development and Evaluation]).
RESULTS: We included six RCTs (5,917 pregnant participants and 6,759 fetuses at less than 34 weeks of gestation at randomization). They were conducted in high-income countries (two in the United States, two across Australia and New Zealand, and one each in Denmark and France) and commenced between 1995 and 2018. Primary outcomes: up to 2 years of corrected age, magnesium sulfate compared with placebo reduced the risk of cerebral palsy (risk ratio [RR] 0.71, 95% CI, 0.57-0.89; six RCTs, 6,107 children) and death or cerebral palsy (RR 0.87, 95% CI, 0.77-0.98; six RCTs, 6,481 children) (high-certainty evidence). Magnesium sulfate had little or no effect on death up to 2 years of corrected age (moderate-certainty evidence) or these outcomes at school age (low-certainty evidence). Although there was little or no effect on death or cardiac or respiratory arrest for pregnant individuals (low-certainty evidence), magnesium sulfate increased adverse effects severe enough to stop treatment (RR 3.21, 95% CI, 1.88-5.48; three RCTs, 4,736 participants; moderate-certainty evidence). Secondary outcome: magnesium sulfate reduced the risk of severe neonatal intraventricular hemorrhage (moderate-certainty evidence).
CONCLUSIONS: Magnesium sulfate for preterm fetal neuroprotection reduces cerebral palsy and death or cerebral palsy for children. Further research is required on longer-term benefits and harms for children, effect variation by participant and treatment characteristics, and the generalizability of findings to low- and middle-income countries.
BACKGROUND: The review protocol was based on a standard Cochrane Pregnancy and Childbirth template and our previous Cochrane Systematic Review (doi: 10.1002/14651858.CD004661.pub3 ; published before the introduction of PROSPERO).
METHODS: We searched Cochrane Pregnancy and Childbirth\'s Trials Register, ClinicalTrials.gov , the World Health Organization International Clinical Trials Registry Platform (through March 17, 2023), and reference lists of relevant studies.
METHODS: Randomized controlled trials (RCTs) assessing magnesium sulfate for fetal neuroprotection in pregnant participants at risk of imminent preterm birth were eligible. Two authors assessed RCTs for inclusion, extracted data, and evaluated risk of bias, trustworthiness, and evidence certainty (GRADE [Grading of Recommendations Assessment, Development and Evaluation]).
RESULTS: We included six RCTs (5,917 pregnant participants and 6,759 fetuses at less than 34 weeks of gestation at randomization). They were conducted in high-income countries (two in the United States, two across Australia and New Zealand, and one each in Denmark and France) and commenced between 1995 and 2018. Primary outcomes: up to 2 years of corrected age, magnesium sulfate compared with placebo reduced the risk of cerebral palsy (risk ratio [RR] 0.71, 95% CI, 0.57-0.89; six RCTs, 6,107 children) and death or cerebral palsy (RR 0.87, 95% CI, 0.77-0.98; six RCTs, 6,481 children) (high-certainty evidence). Magnesium sulfate had little or no effect on death up to 2 years of corrected age (moderate-certainty evidence) or these outcomes at school age (low-certainty evidence). Although there was little or no effect on death or cardiac or respiratory arrest for pregnant individuals (low-certainty evidence), magnesium sulfate increased adverse effects severe enough to stop treatment (RR 3.21, 95% CI, 1.88-5.48; three RCTs, 4,736 participants; moderate-certainty evidence). Secondary outcome: magnesium sulfate reduced the risk of severe neonatal intraventricular hemorrhage (moderate-certainty evidence).
CONCLUSIONS: Magnesium sulfate for preterm fetal neuroprotection reduces cerebral palsy and death or cerebral palsy for children. Further research is required on longer-term benefits and harms for children, effect variation by participant and treatment characteristics, and the generalizability of findings to low- and middle-income countries.
BACKGROUND: The review protocol was based on a standard Cochrane Pregnancy and Childbirth template and our previous Cochrane Systematic Review (doi: 10.1002/14651858.CD004661.pub3 ; published before the introduction of PROSPERO).
摘要：
目的：系统评价硫酸镁作为胎儿神经保护剂对有早产风险的个体的有效性和安全性的证据。
方法：我们搜索了Cochrane妊娠和分娩试验登记册，ClinicalTrials.gov,世界卫生组织国际临床试验注册平台（至2023年3月17日），以及相关研究的参考清单。
方法：随机对照试验（RCTs）评估硫酸镁对有即将早产风险的孕妇的胎儿神经保护作用。两位作者评估了纳入RCT的情况，提取的数据，并评估了偏见的风险，可信度,和证据确定性(等级[建议评估等级，开发和评估])。
结果：我们纳入了6项随机对照试验（随机分组时，妊娠少于34周的5,917名孕妇和6,759名胎儿）。它们是在高收入国家进行的(两个在美国，两个横跨澳大利亚和新西兰，丹麦和法国各一个)，始于1995年至2018年。主要结果：矫正年龄可达2岁，与安慰剂相比，硫酸镁降低了脑瘫的风险（风险比[RR]0.71，95％CI，0.57-0.89；六个随机对照试验，6,107名儿童）和死亡或脑瘫（RR0.87，95%CI，0.77-0.98；六个随机对照试验，6,481名儿童)(高确定性证据)。硫酸镁对矫正年龄2岁以下的死亡（中度确定性证据）或学龄期的这些结果（低度确定性证据）几乎没有影响。尽管对孕妇的死亡或心脏或呼吸停止几乎没有影响（低确定性证据），硫酸镁增加了严重到足以停止治疗的不良反应(RR3.21，95%CI，1.88-5.48；三个随机对照试验，4736名参与者；中等确定性证据)。次要结果：硫酸镁降低严重新生儿脑室内出血的风险（中度确定性证据）。
结论：硫酸镁对早产胎儿的神经保护作用可减少儿童脑瘫和死亡或脑瘫。需要进一步研究儿童的长期利益和危害，效应因参与者和治疗特征而异，以及调查结果对低收入和中等收入国家的普遍性。
背景：审查方案基于标准的Cochrane妊娠和分娩模板以及我们以前的Cochrane系统审查（doi：10.1002/14651858。CD004661。pub3；在引入PROSPERO之前出版)。
方法：我们搜索了Cochrane妊娠和分娩试验登记册，ClinicalTrials.gov,世界卫生组织国际临床试验注册平台（至2023年3月17日），以及相关研究的参考清单。
方法：随机对照试验（RCTs）评估硫酸镁对有即将早产风险的孕妇的胎儿神经保护作用。两位作者评估了纳入RCT的情况，提取的数据，并评估了偏见的风险，可信度,和证据确定性(等级[建议评估等级，开发和评估])。
结果：我们纳入了6项随机对照试验（随机分组时，妊娠少于34周的5,917名孕妇和6,759名胎儿）。它们是在高收入国家进行的(两个在美国，两个横跨澳大利亚和新西兰，丹麦和法国各一个)，始于1995年至2018年。主要结果：矫正年龄可达2岁，与安慰剂相比，硫酸镁降低了脑瘫的风险（风险比[RR]0.71，95％CI，0.57-0.89；六个随机对照试验，6,107名儿童）和死亡或脑瘫（RR0.87，95%CI，0.77-0.98；六个随机对照试验，6,481名儿童)(高确定性证据)。硫酸镁对矫正年龄2岁以下的死亡（中度确定性证据）或学龄期的这些结果（低度确定性证据）几乎没有影响。尽管对孕妇的死亡或心脏或呼吸停止几乎没有影响（低确定性证据），硫酸镁增加了严重到足以停止治疗的不良反应(RR3.21，95%CI，1.88-5.48；三个随机对照试验，4736名参与者；中等确定性证据)。次要结果：硫酸镁降低严重新生儿脑室内出血的风险（中度确定性证据）。
结论：硫酸镁对早产胎儿的神经保护作用可减少儿童脑瘫和死亡或脑瘫。需要进一步研究儿童的长期利益和危害，效应因参与者和治疗特征而异，以及调查结果对低收入和中等收入国家的普遍性。
背景：审查方案基于标准的Cochrane妊娠和分娩模板以及我们以前的Cochrane系统审查（doi：10.1002/14651858。CD004661。pub3；在引入PROSPERO之前出版)。
