加纳子痫和子痫前期管理中新型12小时与24小时硫酸镁治疗方案（MOPEP研究）：一项随机对照试验。

A novel 12-hour versus 24-hour magnesium sulfate regimen in the management of eclampsia and preeclampsia in Ghana (MOPEP Study): A randomized controlled trial.

作者信息

Beyuo Titus K, Lawrence Emma R, Kobernik Emily K, Oppong Samuel A

机构信息

Department of Obstetrics and Gynaecology, University of Ghana Medical School, Accra, Ghana.

Department of Obstetrics and Gynaecology, Korle-Bu Teaching Hospital, Accra, Ghana.

出版信息

Int J Gynaecol Obstet. 2022 Nov;159(2):495-504. doi: 10.1002/ijgo.14181. Epub 2022 Apr 6.

DOI:10.1002/ijgo.14181

PMID:35304745

Abstract

OBJECTIVE

We compared the efficacy of a 12-h versus 24-h regimen of intramuscular magnesium sulfate in the management of eclampsia and preeclampsia.

METHODS

This is an open-labeled parallel randomized controlled trial conducted in Accra, Ghana from November 2018 to November 2020. Participants were adult pregnant women admitted to the Korle Bu Teaching Hospital (KBTH) with a diagnosis of antepartum, intrapartum, or postpartum eclampsia or preeclampsia with severe features, having received no more than a loading dose of magnesium sulfate prior to admission at KBTH. Participants in the standard 24-h group received a loading dose of magnesium sulfate 4 g intravenous and 10 g intramuscular (5 g in each buttock) followed by six, 5 g intramuscular maintenance doses over 24 h. Participants in the 12-h intervention group received the same loading dose followed by three, 5 g intramuscular maintenance doses over 12 h. The primary outcome was occurrence of seizure after completion of the assigned magnesium sulfate regimen. Secondary outcomes were magnesium sulfate toxicity, magnesium sulfate side effects, maternal outcomes (mode of delivery, duration of inpatient admission, duration of urethral catheterization), maternal complications (pulmonary edema, acute kidney injury, intensive care unit admission, death), and neonatal outcomes.

RESULTS

Among 1176 total participants, we found no difference in occurrence of seizure after completion of the assigned regimen in the 24-h group (n = 5, 0.9%) versus the 12-h group (n = 2, 0.3%), P = 0.29; RR 0.40, 95% CI 0.08, 2.04), or in occurrence of seizure any time after enrollment (n = 9, 1.5% vs. n = 5, 0.9%, P = 0.28, RR 0.55, 95% CI 0.19-1.64). Participants in the 12-h group had a shorter duration of inpatient admission (9.4 ± 8.8 vs. 7.7 ± 6.5 days, P = 0.0009) and urethral catheterization (2.1 ± 1.0 vs. 1.9 ± 1.3 days, P < 0.0001). Rates of side effects from magnesium sulfate were lower in the 12-h group: pain at the injection site (94.8% (n = 548) vs. 91.5% (n = 540), P = 0.03), inflammation (62.2% (n = 358) vs. 40.0% (n = 237), P < 0.0001), and bleeding or bruising at the injection site (25.1% (n = 144) vs. 14.4% (n = 85), P < 0.0001).

CONCLUSIONS

Compared with 24 h, 12 h of intramuscular magnesium sulfate showed similar rates of seizures, with fewer side effects and shorter inpatient admission.

TRIAL REGISTRATION

Prospective registration was with Pan African Clinical Trial Registry (PACTR201811515303983): https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=4690.

摘要

目的

我们比较了肌内注射硫酸镁12小时方案与24小时方案在子痫和先兆子痫管理中的疗效。

方法

这是一项开放标签的平行随机对照试验，于2018年11月至2020年11月在加纳阿克拉进行。参与者为成年孕妇，她们因产前、产时或产后子痫或伴有严重特征的先兆子痫而入住科勒布教学医院（KBTH），且在入住KBTH之前接受的硫酸镁负荷剂量不超过规定剂量。标准24小时组的参与者先静脉注射4克硫酸镁负荷剂量，然后肌内注射10克（每侧臀部5克），随后在24小时内分六次肌内注射5克维持剂量。12小时干预组的参与者接受相同的负荷剂量，然后在12小时内分三次肌内注射5克维持剂量。主要结局是在完成指定的硫酸镁治疗方案后癫痫发作的发生情况。次要结局包括硫酸镁毒性、硫酸镁副作用、母体结局（分娩方式、住院时间、导尿时间）、母体并发症（肺水肿、急性肾损伤、入住重症监护病房、死亡）和新生儿结局。

结果

在1176名总参与者中，我们发现24小时组（n = 5，0.9%）与12小时组（n = 2，0.3%）在完成指定治疗方案后癫痫发作的发生率上没有差异（P = 0.29；RR 0.40，95% CI 0.08，2.04），在入组后任何时间癫痫发作的发生率上也没有差异（n = 9，1.5% 对 n = 5，0.9%，P = 0.28，RR 0.55，95% CI 0.19 - 1.64）。12小时组的参与者住院时间较短（9.4 ± 8.8天对比7.7 ± 并6.5天，P = 0.0009），导尿时间也较短（2.1 ± 1.0天对比1.9 ± 1.3天，P < 0.0001）。硫酸镁副作用的发生率在12小时组较低：注射部位疼痛（94.8%（n = 548）对比91.5%（n = 540），P = 0.03）、炎症（62.2%（n = 358）对比40.0%（n = 237），P < 0.0001）以及注射部位出血或瘀伤（25.1%（n = 144）对比14.4%（n = 85），P < 0.0001）。