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硫酸镁治疗缺氧缺血性脑病新生儿的结局:系统评价与荟萃分析。

Outcomes of Neonates with Hypoxic-Ischemic Encephalopathy Treated with Magnesium Sulfate: A Systematic Review with Meta-analysis.

机构信息

Neurology, Perth Children's Hospital, Nedlands, Western Australia, Australia.

Neonatology, Joondalup Health Campus, Joondalup, Western Australia, Australia; Pediatrics, Rockingham General Hospital, Coolongup, Western Australia, Australia.

出版信息

J Pediatr. 2023 Nov;262:113610. doi: 10.1016/j.jpeds.2023.113610. Epub 2023 Jul 17.

DOI:10.1016/j.jpeds.2023.113610
PMID:37468038
Abstract

OBJECTIVE

To assess magnesium sulfate (MgSO) as a neuroprotective agent in hypoxic-ischemic encephalopathy.

STUDY DESIGN

For this systematic review, PubMed, EMBASE, the Cochrane Library, EMCARE, and MedNar were searched in November 2022 for randomized controlled trials (RCTs). Meta-analysis was conducted using Stata 16.0 and RevMan 5.3.

RESULTS

Twenty RCTs with a total sample size of 1485 were included, of which 16 were from settings where therapeutic hypothermia (TH) was not offered. Regarding MgSO in settings where TH was not offered, only 1 study evaluated composite outcome of death or disability at ≥18 months and reported such poor outcome in 8 of 14 control infants and 4 of 8 in the MgSO group. MgSO was not associated with mortality (RR, 0.86; 95% CI, 0.72-1.03; 13 RCTs) or hypotension (RR, 1.02; 95% CI, 0.88-1.18; 5 RCTs). Thirteen studies reported that MgSO improved in-hospital outcomes, such as reduced seizure burden and improved neurological status at discharge. MgSO reduced the risk of poor suck feeds (RR, 0.52; 95% CI, 0.40-0.68; 6RCTs) and abnormal electroencephalogram (RR, 0.64; 95% CI, 0.45-0.93; 5 RCTs). Certainty of evidence was moderate for mortality and low or very low for other outcomes. For studies with MgSO as an adjunct to TH, none reported on death or neurodevelopmental disability at ≥18 months. MgSO was not associated with mortality (RR, 0.65; 95% CI, 0.34-1.27; 3 RCTs) or hypotension (RR, 1.0; 95% CI, 0.71-1.40; 3 RCTs).

CONCLUSIONS

Evidence around long-term outcomes of MgSO when used with or without TH was scant. MgSO therapy may improve in-hospital neurological outcomes without affecting mortality in settings where TH is not offered. Well-designed RCTs for neuroprotection are needed, especially in low-resource settings.

TRIAL REGISTRATION

"Open Science Forum" (https://doi.org/10.17605/OSF.IO/FRM4D).

摘要

目的

评估硫酸镁(MgSO)在缺氧缺血性脑病中的神经保护作用。

研究设计

本系统评价检索了 2022 年 11 月的 PubMed、EMBASE、Cochrane 图书馆、EMCARE 和 MedNar,以寻找随机对照试验(RCT)。使用 Stata 16.0 和 RevMan 5.3 进行荟萃分析。

结果

共纳入 20 项 RCT,总样本量为 1485 例,其中 16 项研究的治疗性低体温(TH)未被纳入。对于未采用 TH 的 MgSO 研究,仅有 1 项研究评估了 18 个月及以上的死亡或残疾复合结局,并报告 14 例对照组婴儿中有 8 例和 8 例 MgSO 组中有 4 例预后不良。MgSO 与死亡率(RR,0.86;95%CI,0.72-1.03;13 项 RCT)或低血压(RR,1.02;95%CI,0.88-1.18;5 项 RCT)无关。13 项研究报告称,MgSO 可改善住院结局,如减少癫痫发作负担和出院时的神经状态改善。MgSO 降低了喂养不良(RR,0.52;95%CI,0.40-0.68;6 项 RCT)和脑电图异常(RR,0.64;95%CI,0.45-0.93;5 项 RCT)的风险。对于死亡率,证据确定性为中等,对于其他结局为低或极低。对于有 MgSO 作为 TH 辅助治疗的研究,没有报告 18 个月及以上的死亡或神经发育残疾。MgSO 与死亡率(RR,0.65;95%CI,0.34-1.27;3 项 RCT)或低血压(RR,1.0;95%CI,0.71-1.40;3 项 RCT)无关。

结论

关于 MgSO 在有或没有 TH 时的长期结局的证据很少。在未提供 TH 的情况下,MgSO 治疗可能改善住院期间的神经结局,而不影响死亡率。需要进行精心设计的神经保护 RCT,尤其是在资源匮乏的环境中。

试验注册

“开放科学论坛”(https://doi.org/10.17605/OSF.IO/FRM4D)。

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