普里查德方案:12小时硫酸镁维持疗法与24小时硫酸镁维持疗法对重度子痫前期妇女癫痫发作和产妇结局的影响:三重盲随机对照试验》(The Effect of 12-Hour Vers 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)。

Samuel Okwuchukwu Ilikannu, Peter Ndidi Ebeigbe, Angela Uduak Ochei
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引用次数: 0

摘要

背景:硫酸镁(MgSO4)用药 24 小时是重度子痫前期患者预防癫痫发作的首选药物。由于硫酸镁的治疗指数较窄,缩短产后硫酸镁的用药时间不仅能预防癫痫发作,还能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疗法对重度子痫前期患者癫痫发作和产妇预后的疗效:在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妇女进行了三盲随机对照试验。研究的主要结果是两组研究中的任何一组出现癫痫发作。146 名妇女被随机分为两组,一组接受 12 小时的硫酸镁治疗,其余 12 小时接受安慰剂治疗(I 组),另一组在产后接受 24 小时的硫酸镁治疗(II 组)。收集到的数据使用统计产品和服务解决方案(SPSS)第 26 版和 pResults 进行编码和分析:两组在癫痫发作、是否需要重新开始使用硫酸镁、硫酸镁的临床毒性证据和不良反应方面没有统计学差异。此外,两组在硫酸镁总用量、尿道导管插入时间和住院时间方面也无明显统计学差异。本研究中没有产妇死亡记录:本研究结果表明,在预防癫痫发作方面,12 小时硫酸镁维持疗法与传统的 24 小时疗法同样有效,且不会恶化产妇预后。
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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.

Background: Magnesium sulphate (MgSO4) 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 MgSO4 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 MgSO4 regimen and placebo for the remaining twelve hours (Group I) and those who received a 24-hour MgSO4 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 MgSO4, 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 MgSO4 maintenance regimen is as efficacious as the traditional 24-hour regimen in preventing seizures without worsening maternal outcomes.

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