Belfort Michael A, Anthony John, Saade George R, Allen John C
Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, USA.
N Engl J Med. 2003 Jan 23;348(4):304-11. doi: 10.1056/NEJMoa021180.
Magnesium sulfate may prevent eclampsia by reducing cerebral vasoconstriction and ischemia. Nimodipine is a calcium-channel blocker with specific cerebral vasodilator activity. Our objective was to determine whether nimodipine is more effective than magnesium sulfate for seizure prophylaxis in women with severe preeclampsia.
We conducted an unblinded, multicenter trial in which 1650 women with severe preeclampsia were randomly assigned to receive either nimodipine (60 mg orally every 4 hours) or intravenous magnesium sulfate (given according to the institutional protocol) from enrollment until 24 hours post partum. High blood pressure was controlled with intravenous hydralazine as needed. The primary outcome measure was the development of eclampsia, as defined by a witnessed tonic-clonic seizure.
Demographic and clinical characteristics were similar in the two groups. The women who received nimodipine were more likely to have a seizure than those who received magnesium sulfate (21 of 819 [2.6 percent] vs. 7 of 831 [0.8 percent], P=0.01). The adjusted risk ratio for eclampsia associated with nimodipine, as compared with magnesium sulfate, was 3.2 (95 percent confidence interval, 1.1 to 9.1). The antepartum seizure rates did not differ significantly between groups, but the nimodipine group had a higher rate of postpartum seizures (9 of 819 [1.1 percent] vs. 0 of 831, P=0.01). There were no significant differences in neonatal outcome between the two groups. More women in the magnesium sulfate group than in the nimodipine group needed hydralazine to control blood pressure (54.3 percent vs. 45.7 percent, P<0.001).
Magnesium sulfate is more effective than nimodipine for prophylaxis against seizures in women with severe preeclampsia.
硫酸镁可通过减轻脑血管收缩和缺血来预防子痫。尼莫地平是一种具有特定脑血管舒张活性的钙通道阻滞剂。我们的目的是确定在重度子痫前期妇女中,尼莫地平预防癫痫发作是否比硫酸镁更有效。
我们进行了一项非盲、多中心试验,1650例重度子痫前期妇女从入组至产后24小时被随机分配接受尼莫地平(每4小时口服60毫克)或静脉注射硫酸镁(根据机构方案给药)。必要时用静脉注射肼屈嗪控制高血压。主要结局指标是子痫的发生,定义为目睹的强直阵挛发作。
两组的人口统计学和临床特征相似。接受尼莫地平治疗的妇女比接受硫酸镁治疗的妇女更易发生癫痫发作(819例中的21例[2.6%] vs. 831例中的7例[0.8%],P = 0.01)。与硫酸镁相比,尼莫地平相关子痫的校正风险比为3.2(95%置信区间,1.1至9.1)。两组产前癫痫发作率无显著差异,但尼莫地平组产后癫痫发作率更高(819例中的9例[1.1%] vs. 831例中的0例,P = 0.01)。两组新生儿结局无显著差异。硫酸镁组比尼莫地平组更多妇女需要用肼屈嗪控制血压(54.3% vs. 45.7%,P<0.001)。
在重度子痫前期妇女中,硫酸镁预防癫痫发作比尼莫地平更有效。