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首页> 外文期刊>Journal of clinical neuroscience: official journal of the Neurosurgical Society of Australasia >Critical relationship between sodium valproate dose and human teratogenicity: results of the Australian register of anti-epileptic drugs in pregnancy.
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Critical relationship between sodium valproate dose and human teratogenicity: results of the Australian register of anti-epileptic drugs in pregnancy.

机译：丙戊酸钠剂量与人致畸性之间的关键关系：妊娠期抗癫痫药物的澳大利亚注册结果。

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摘要

To compare the incidence of foetal malformations (FMs) in pregnant women with epilepsy treated with different anti-epileptic drugs (AED) and doses, and the influence of seizures, family and personal history, and environmental factors. A prospective, observational, community-based cohort study. Methods. A voluntary, Australia-wide, telephone-interview-based register prospectively enrolling three groups of pregnant women: taking AEDs for epilepsy; with epilepsy not taking AEDs; taking AEDs for a non-epileptic indication. Four hundred and fifty eligible women were enrolled over 40 months. Three hundred and ninety six pregnancies had been completed, with 7 sets of twins, for a total of 403 pregnancy outcomes. Results. 354 (87.8%) pregnancy outcomes resulted in a healthy live birth, 26 (6.5%) had a FM, 4 (1%) a death in utero, 1 (0.2%) a premature labour with stillbirth, 14 (3.5%) a spontaneous abortion and 4 lost to follow-up. The FM rate was greater in pregnancies exposed to sodium valproate (VPA) in the first trimester (16.0%) compared with those exposed to all other AEDs (16.0% vs. 2.4%, [Formula: see text] ) or no AEDs (16.0% vs. 3.1%, [Formula: see text] ). The mean daily dose of VPA taken in pregnancy with FMs was significantly greater than in those without (1975 vs. 1128 mg, [Formula: see text] ). The incidence of FM with VPA doses 1100 mg was 30.2% vs. 3.2% with doses [Formula: see text] 1100 mg ( [Formula: see text] ). Conclusions. There is a dose-effect relationship for FM and exposure to VPA during the first trimester of pregnancy, with higher doses of VPA associated with a significantly greater risk than with lower doses or with other AEDs. These results highlight the need to limit, where possible, the dose of VPA in pregnancy.
机译：比较使用不同抗癫痫药（AED）和剂量治疗的癫痫孕妇的胎儿畸形（FMs）发生率，以及癫痫发作，家庭和个人病史以及环境因素的影响。前瞻性，观察性，基于社区的队列研究。方法。一项自愿的，基于澳大利亚电话采访的登记簿，预期招募三组孕妇：服用AED进行癫痫治疗;癫痫不服用抗癫痫药;服用AED作为非癫痫适应症。在40个月内，有450名合格的女性入组。已完成396例怀孕，其中有7对双胞胎，总共有403例妊娠结果。结果。 354（87.8％）个妊娠结局可带来健康的活产，26个（6.5％）患有FM，子宫内死亡4（1％），1个（0.2％）有死产的早产，14（3.5％）a自发流产和4失去随访。与所有其他AED（16.0％vs. 2.4％，[公式：见正文]）或无AED（16.0％）相比，在孕早期暴露于丙戊酸钠（VPA）的孕妇中的FM率更高（16.0％）。 ％与3.1％，[公式：请参见文字]）。 FMs孕妇在怀孕期间服用的VPA的平均日剂量明显高于未服用FMs的孕妇（1975 vs. 1128 mg，[公式：见正文]）。 VPA剂量为1100 mg时，FM的发生率为30.2％，而剂量为1100 mg时，FM的发生率为3.2％（公式：参见文本）。结论。在怀孕的头三个月期间，FM和暴露于VPA之间存在剂量效应关系，与较低剂量或其他AED相比，较高剂量的VPA与明显更高的风险相关。这些结果表明，有必要限制怀孕中VPA的剂量。

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