Risk of seizures in neonates with hypoxic-ischemic encephalopathy receiving hypothermia plus erythropoietin or placebo.

Risk of seizures in neonates with hypoxic-ischemic encephalopathy receiving hypothermia plus erythropoietin or placebo.
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DOI:
10.1038/s41390-022-02398-w
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发表时间:
2023-07
期刊:
影响因子:
3.6
通讯作者:
Wu, Yvonne W.
Wu, Yvonne W.
中科院分区:
医学3区
文献类型:
--
作者:
Glass, Hannah C.;Wusthoff, Courtney J.;Comstock, Bryan A.;Numis, Adam L.;Gonzalez, Fernando F.;Maitre, Nathalie;Massey, Shavonne L.;Mayock, Dennis E.;Mietzsch, Ulrike;Natarajan, Niranjana;Sokol, Gregory M.;Bonifacio, Sonia L.;Van Meurs, Krisa P.;Thomas, Cameron;Ahmad, Kaashif A.;Heagerty, Patrick J.;Juul, Sandra E.;Wu, Yvonne W.

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大剂量促红细胞生成素治疗窒息和脑病(Heal)试验的一项辅助研究证实了一项假设,即随机接受促红细胞生成素(EPO)治疗的新生儿与接受安慰剂治疗的新生儿相比,癫痫风险和负担更低。本文回顾了7/17个HELL试验中心的脑电。使用Logistic回归模型比较了不同治疗组的癫痫发作情况,调整了治疗、HIE严重程度、中心和第一次服药前的癫痫负担。在有癫痫发作的新生儿中,使用调整后的分位数回归模型评估不同治疗组之间最大每小时癫痫发作负荷的中位数差异。150名新生儿中有46名(31%)出现脑电发作(EPO组31%,安慰剂组30%,p=0.96)。两组研究药物后每小时最大癫痫发作负荷无显著差异(EPO组中位数11.4,IQR:5.6,18.1对中位数9.7,IQR:4.9,安慰剂组21.0分钟/小时)。在接受低温治疗的HIE新生儿中,我们随机接受EPO或安慰剂治疗,我们发现两组之间在癫痫风险或负担方面没有显著差异。这些发现与总体试验结果一致,这些试验结果不支持对正在接受治疗性低温的HIE新生儿使用EPO。
An ancillary study to the High-Dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial of for neonates with hypoxic-ischemic encephalopathy (HIE) and treated with therapeutic hypothermia examined the hypothesis that neonates randomized to receive erythropoietin (Epo) would have a lower seizure risk and burden compared with neonates who received placebo. Electroencephalograms (EEGs) from 7/17 HEAL trial centers were reviewed. Seizure presence was compared across treatment groups using a logistic regression model adjusting for treatment, HIE severity, center, and seizure burden prior to first dose. Among neonates with seizures, differences across treatment groups in median maximal hourly seizure burden were assessed using adjusted quantile regression models. Forty-six of 150 (31%) of neonates had EEG seizures (31% in Epo vs 30% in placebo, p=0.96). Maximal hourly seizure burden after study drug was not significantly different between groups (median 11.4 for Epo, IQR: 5.6, 18.1 vs median 9.7, IQR: 4.9, 21.0 minutes/hour for placebo). In neonates with HIE treated with hypothermia who were randomized to Epo or placebo, we found no meaningful between-group difference in seizure risk or burden. These findings are consistent with overall trial results, which do not support Epo use for neonates with HIE undergoing therapeutic hypothermia.
达贝泊汀对因脑病而接受降温的新生儿进行给药:一项安全性和药代动力学试验。
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