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硫酸镁与硝苯地平用于早产急性保胎治疗的比较:一项随机对照试验

Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a randomized controlled trial.

作者信息

Lyell Deirdre J, Pullen Kristin, Campbell Laura, Ching Suzanne, Druzin Maurice L, Chitkara Usha, Burrs Demetra, Caughey Aaron B, El-Sayed Yasser Y

机构信息

Department of Obstetrics and Gynecology, Stanford University Medical Center, Lucile S. Packard Children's Hospital, Stanford, California, USA.

出版信息

Obstet Gynecol. 2007 Jul;110(1):61-7. doi: 10.1097/01.AOG.0000269048.06634.35.

Abstract

OBJECTIVE

To compare the efficacy and side effects of intravenous magnesium to oral nifedipine for acute tocolysis of preterm labor.

METHODS

A multicenter randomized trial was performed. Patients in active preterm labor who were at 24 to 33 weeks and 6 days of gestation were randomly assigned to receive magnesium sulfate or nifedipine. The primary outcome was arrest of preterm labor, defined as prevention of delivery for 48 hours with uterine quiescence.

RESULTS

One hundred ninety-two patients were enrolled. More patients assigned to magnesium sulfate achieved the primary outcome (87% compared with 72%, P=.01). There were no differences in delivery within 48 hours (7.6% magnesium sulfate compared with 8.0% nifedipine, P=.92), gestational age at delivery (35.8 compared with 36.0 weeks, P=.61), birth before 37 and 32 weeks (57% compared with 57%, P=.97, and 11% compared with 8%, P=.39), and episodes of recurrent preterm labor. Mild and severe maternal adverse effects were significantly more frequent with magnesium sulfate. Birth weight, birth weight less than 2,500 g, and neonatal morbidities were similar between groups, but newborns in the magnesium sulfate group spent longer in the neonatal intensive care unit (8.8+/-17.7 compared with 4.2+/-8.2 days, P=.007).

CONCLUSION

Patients who received magnesium sulfate achieved the primary outcome more frequently. However, delay of delivery, gestational age at delivery, and neonatal outcomes were similar between groups. Nifedipine was associated with fewer maternal adverse effects.

摘要

目的

比较静脉注射镁剂与口服硝苯地平用于早产急性宫缩抑制的疗效及副作用。

方法

进行了一项多中心随机试验。将妊娠24至33周6天处于早产活跃期的患者随机分配接受硫酸镁或硝苯地平治疗。主要结局为早产抑制,定义为子宫静止且预防分娩48小时。

结果

共纳入192例患者。分配接受硫酸镁治疗的患者更多达到主要结局(87% 对比72%,P = 0.01)。48小时内分娩情况无差异(硫酸镁组7.6% 对比硝苯地平组8.0%,P = 0.92),分娩时孕周无差异(35.8周对比36.0周,P = 0.61),37周前及32周前出生情况无差异(57% 对比57%,P = 0.97;11% 对比8%,P = 0.39),复发性早产发作情况也无差异。硫酸镁组轻度和重度母体不良反应明显更常见。两组间出生体重、出生体重低于2500g及新生儿发病率相似,但硫酸镁组新生儿在新生儿重症监护病房的住院时间更长(8.8±17.7天对比)。

结论

接受硫酸镁治疗的患者更频繁地达到主要结局。然而,两组间分娩延迟、分娩时孕周及新生儿结局相似。硝苯地平相关的母体不良反应较少。 4.2±8.2天,P = 0.007)

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