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肥胖子痫前期妇女硫酸镁间断给药方案:一项随机对照试验。

Alternate Dosing Protocol for Magnesium Sulfate in Obese Women With Preeclampsia: A Randomized Controlled Trial.

机构信息

Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, Oregon; and the Department of Anesthesia, Stanford University School of Medicine, Stanford, California.

出版信息

Obstet Gynecol. 2020 Dec;136(6):1190-1194. doi: 10.1097/AOG.0000000000004137.

Abstract

OBJECTIVE

To evaluate whether obese women need greater doses of magnesium sulfate to obtain therapeutic serum concentrations for eclamptic seizure prevention.

METHODS

Women with preeclampsia and a body mass index (BMI) of 35 or higher were randomly allocated to either the Zuspan regimen of magnesium sulfate (4-g intravenous [IV] loading dose, then a 1-g/h infusion) or to alternate dosing (6-g IV loading dose, then a 2-g/h infusion). Women had serum magnesium concentrations obtained at baseline, as well as after administration of magnesium sulfate at 1 hour, 4 hours, and delivery. The primary outcome was the proportion of women who had subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration. A sample size of 18 women per group was planned to compare the proportion of women with subtherapeutic serum magnesium concentrations in each group.

RESULTS

From July 12, 2016, to March 14, 2019, 89 women with preeclampsia were screened and 37 were enrolled: 18 to the Zuspan regimen and 19 to the alternate regimen. A significantly greater proportion of women administered the Zuspan regimen had subtherapeutic serum magnesium concentrations at 4 hours (100% [95% CI 59-100] vs 63% [95% CI 41-81]; P=.01) compared with women administered the alternate higher dose regimen. At 4 hours, mean concentrations were significantly higher in the alternate regimen group (3.53 mg/dL±0.3 [Zuspan regimen] vs 4.41±0.5 [alternate regimen]; P<.01).

CONCLUSION

The alternate dosing regimen of a 6-g IV loading dose followed by a 2-g/h IV maintenance dose more reliably achieves therapeutic serum magnesium concentrations (as defined by a concentration of at least 4.8 mg/dL) in obese women with preeclampsia.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT02835339.

摘要

目的

评估肥胖女性是否需要更大剂量的硫酸镁才能达到治疗性血清浓度以预防子痫发作。

方法

将患有子痫前期且体重指数(BMI)≥35 的女性随机分配至 Zuspan 硫酸镁方案(4g 静脉推注负荷剂量,然后 1g/h 输注)或交替剂量方案(6g 静脉推注负荷剂量,然后 2g/h 输注)。女性在基线时以及给予硫酸镁后 1 小时、4 小时和分娩时获得血清镁浓度。主要结局是 4 小时后血清镁浓度低于 4.8mg/dL 的女性比例。计划每组 18 名女性的样本量旨在比较每组血清镁浓度低于治疗范围的女性比例。

结果

从 2016 年 7 月 12 日至 2019 年 3 月 14 日,共筛选了 89 例患有子痫前期的女性,其中 37 例入选:18 例接受 Zuspan 方案,19 例接受交替方案。接受 Zuspan 方案治疗的女性中,4 小时时血清镁浓度低于治疗范围的比例明显更高(100%[95%CI 59-100] vs. 63%[95%CI 41-81];P=.01),与接受交替高剂量方案治疗的女性相比。在 4 小时时,交替方案组的平均浓度明显更高(3.53mg/dL±0.3[Zuspan 方案] vs. 4.41±0.5[交替方案];P<.01)。

结论

在患有子痫前期的肥胖女性中,6g 静脉推注负荷剂量后给予 2g/h 静脉维持剂量的交替剂量方案更可靠地达到治疗性血清镁浓度(定义为浓度至少 4.8mg/dL)。

临床试验注册

ClinicalTrials.gov,NCT02835339。

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