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子痫女性应使用哪种抗惊厥药物?来自子痫协作试验的证据。

Which anticonvulsant for women with eclampsia? Evidence from the Collaborative Eclampsia Trial.

出版信息

Lancet. 1995 Jun 10;345(8963):1455-63.

PMID:7769899
Abstract

Eclampsia, the occurrence of a seizure in association with pre-eclampsia, remains an important cause of maternal mortality. Although it is standard practice to use an anticonvulsant for management of eclampsia, the choice of agent is controversial and there has been little properly controlled evidence to support any of the options. 1687 women with eclampsia were recruited into an international multicentre randomised trial comparing standard anticonvulsant regimens. Primary measures of outcome were recurrence of convulsions and maternal death. Data are available for 1680 (99.6%) women: 453 allocated magnesium sulphate versus 452 allocated diazepam, and 388 allocated magnesium sulphate versus 387 allocated phenytoin. Most women (99%) received the anticonvulsant that they had been allocated. Women allocated magnesium sulphate had a 52% lower risk of recurrent convulsions (95% CI 64% to 37% reduction) than those allocated diazepam (60 [13.2%] vs 126 [27.9%]; ie, 14.7 [SD 2.6] fewer women with recurrent convulsions per 100 women; 2p < 0.00001). Maternal mortality was non-significantly lower among women allocated magnesium sulphate. There were no significant differences in other measures of serious maternal morbidity, or in perinatal morbidity or mortality. Women allocated magnesium sulphate had a 67% lower risk of recurrent convulsions (95% CI 79% to 47% reduction) than those allocated phenytoin (22 [5.7%] vs 66 [17.1%] ie, 11.4 [SD 2.2] fewer women with recurrent convulsions per 100 women; 2p < 0.00001). Maternal mortality was nonsignificantly lower among women allocated magnesium sulphate. Women allocated magnesium sulphate were also less likely to be ventilated, to develop pneumonia, and to be admitted to intensive care facilities than those allocated phenytoin. The babies of women who had been allocated magnesium sulphate before delivery were significantly less likely to be intubated at the place of delivery, and to be admitted to a special care nursery, than the babies of mothers who had been allocated phenytoin. There is now compelling evidence in favour of magnesium sulphate, rather than diazepam or phenytoin, for the treatment of eclampsia.

摘要

子痫,即与先兆子痫相关的惊厥发作,仍是孕产妇死亡的重要原因。尽管使用抗惊厥药物治疗子痫是标准做法,但药物的选择存在争议,几乎没有充分对照的证据支持任何一种选择。1687名子痫患者被纳入一项国际多中心随机试验,比较标准抗惊厥治疗方案。主要结局指标为惊厥复发和孕产妇死亡。1680名(99.6%)女性的数据可用:453名分配至硫酸镁组,452名分配至地西泮组,388名分配至硫酸镁组,387名分配至苯妥英组。大多数女性(99%)接受了分配给她们的抗惊厥药物。分配至硫酸镁组的女性惊厥复发风险比分配至地西泮组的女性低52%(95%CI降低64%至37%)(60例[13.2%]对126例[27.9%];即每100名女性中惊厥复发的女性少14.7例[标准差2.6];P<0.00001)。分配至硫酸镁组的女性孕产妇死亡率略低,但无统计学意义。在其他严重孕产妇发病指标、围产期发病率或死亡率方面无显著差异。分配至硫酸镁组的女性惊厥复发风险比分配至苯妥英组的女性低67%(95%CI降低79%至47%)(22例[5.7%]对66例[17.1%];即每100名女性中惊厥复发的女性少11.4例[标准差2.2];P<0.00001)。分配至硫酸镁组的女性孕产妇死亡率略低,但无统计学意义。与分配至苯妥英组的女性相比,分配至硫酸镁组的女性接受通气、发生肺炎和入住重症监护病房的可能性也较小。分娩前分配至硫酸镁组的女性所生婴儿在分娩时插管和入住特殊护理病房的可能性明显低于分配至苯妥英组的母亲所生婴儿。现在有令人信服的证据支持使用硫酸镁而非地西泮或苯妥英治疗子痫。

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