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普里查德方案:12小时与24小时硫酸镁维持方案对重度子痫前期女性癫痫发作发生率及母儿结局的影响:一项三盲随机对照试验

Pritchard's Regimen: The Effect of 12-Hour Versus 24-Hour Magnesium Sulphate Maintenance Regimen on the Occurrence of Seizures and Maternal Outcome in Women with Severe Features of Preeclampsia: A Triple-Blind Randomized Controlled Trial.

作者信息

Ilikannu Samuel Okwuchukwu, Ebeigbe Peter Ndidi, Ochei Angela Uduak

机构信息

Department ofObstetrics and Gynaecology, Federal Medical CentreAsaba, Asaba, Delta State, Nigeria.

Department of Obstetrics and GynaecologyDelta State University Teaching Hospital, Oghara, Delta State, Nigeria.

出版信息

Niger Med J. 2024 Jun 20;65(3):320-331. doi: 10.60787/nmj-v65i3-434. eCollection 2024 May-Jun.

Abstract

BACKGROUND

Magnesium sulphate (MgSO) administered for twenty-four hours is the drug of choice for seizure prophylaxis in patients with preeclampsia with severe features. Due to its narrow therapeutic index, a reduction in the duration of MgSO administered in the postpartum period may not only prevent the occurrence of seizures but also reduce the adverse effects associated with this drug. This study aimed to compare the efficacy of the 12-hour and 24-hour Pritchard's MgSO4 maintenance regimen on the occurrence of seizures and maternal outcomes in patients with preeclampsia with severe features.

METHODOLOGY

A triple-blind randomized controlled trial was conducted among women with preeclampsia with severe features between 1st June 2022 and January 31st, 2023. The primary outcome measure was the occurrence of seizure in either arm of the study. One hundred and forty-six women were randomized into two groups, those who received a 12-hour MgSO regimen and placebo for the remaining twelve hours (Group I) and those who received a 24-hour MgSO regimen in the postpartum period (Group II). The collected data was coded and analyzed using Statistical Product and Service Solutions (SPSS) version 26 and p<0.05 was considered significant.

RESULTS

There was no statistically significant difference between the two groups concerning the occurrence of seizures, the need to recommence MgSO, clinical evidence of toxicity and adverse effects of MgSO4. There was also no statistically significant difference between the two groups in the total dose of MgSO4 administered, duration of urethral catheterization and duration of hospital admission. No maternal mortality was recorded in this study.

CONCLUSION

The results of this study suggest that the 12-hour MgSO maintenance regimen is as efficacious as the traditional 24-hour regimen in preventing seizures without worsening maternal outcomes.

摘要

背景

硫酸镁(MgSO)给药24小时是重度子痫前期患者预防癫痫发作的首选药物。由于其治疗指数狭窄,产后硫酸镁给药时间的缩短不仅可以预防癫痫发作的发生,还可以减少与该药物相关的不良反应。本研究旨在比较12小时和24小时普里查德硫酸镁维持方案对重度子痫前期患者癫痫发作发生率和孕产妇结局的疗效。

方法

2022年6月1日至2023年1月31日期间,对患有重度子痫前期的女性进行了一项三盲随机对照试验。主要结局指标是研究任一臂中癫痫发作的发生情况。146名女性被随机分为两组,一组接受12小时硫酸镁方案,其余12小时接受安慰剂(第一组),另一组在产后接受24小时硫酸镁方案(第二组)。使用统计产品与服务解决方案(SPSS)26版对收集的数据进行编码和分析,p<0.05被认为具有统计学意义。

结果

两组在癫痫发作发生率、重新开始使用硫酸镁的必要性、毒性临床证据以及硫酸镁的不良反应方面没有统计学显著差异。两组在硫酸镁给药总量、导尿持续时间和住院时间方面也没有统计学显著差异。本研究未记录孕产妇死亡情况。

结论

本研究结果表明,12小时硫酸镁维持方案在预防癫痫发作方面与传统的24小时方案同样有效,且不会使孕产妇结局恶化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0a1/11249484/7cc37e19d38c/nmj-65-320-f1.jpg

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