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澳大利亚孕期抗癫痫药物登记册:前1002例妊娠情况

The Australian Register of Antiepileptic Drugs in Pregnancy: the first 1002 pregnancies.

作者信息

Vajda Frank J E, Hitchcock Alison, Graham Janet, O'Brien Terence, Lander Cecilie, Eadie Mervyn

机构信息

Department of Medicine, Monash University and Medical Centre, Clayton, Victoria, Australia.

出版信息

Aust N Z J Obstet Gynaecol. 2007 Dec;47(6):468-74. doi: 10.1111/j.1479-828X.2007.00781.x.

DOI:10.1111/j.1479-828X.2007.00781.x
PMID:17991111
Abstract

BACKGROUND

Prospective studies are needed to assess the maternal and fetal hazards of antiepileptic drug (AED) therapy in pregnancy.

AIMS

To make the Australian Register of AEDs in Pregnancy better known to the Australian obstetric community by presenting results derived from it.

METHODS

Analysis of data collected by the Register between 1999 and December 2006.

RESULTS

The Register contained data on 1002 epileptic or AED-treated pregnancies, 992 with known outcomes, 83 not exposed to AEDs in at least their first trimester, and 30 prescribed AEDs for indications other than epilepsy. Statistically significant findings included more frequent folate supplementation and decreased alcohol intake during pregnancy in women with epilepsy; a dose-related increased risk of fetal malformation associated with valproate therapy; a tendency towards lower birthweights in live-born malformed offspring; and a substantially reduced decreased risk of seizures in pregnancy with one year seizure freedom before pregnancy. The small numbers of patients may have prevented other differences from reaching a P<0.05 value.

CONCLUSIONS

The Register has already produced important information for the management of pregnant women with epilepsy in Australia, but greater rates of recruitment into the Register are desirable to allow it to achieve its full potential.

摘要

背景

需要进行前瞻性研究来评估孕期抗癫痫药物(AED)治疗对母婴的危害。

目的

通过展示澳大利亚孕期AED登记册得出的结果,让澳大利亚产科界更好地了解该登记册。

方法

分析登记册在1999年至2006年12月期间收集的数据。

结果

登记册包含1002例癫痫或接受AED治疗的妊娠数据,992例有已知结局,83例在孕早期至少未接触过AED,30例因癫痫以外的适应症开具AED。具有统计学意义的发现包括癫痫女性孕期补充叶酸更频繁且饮酒减少;丙戊酸治疗与胎儿畸形风险增加存在剂量相关性;存活的畸形后代出生体重有降低趋势;孕前无癫痫发作一年的孕妇孕期癫痫发作风险大幅降低。患者数量较少可能使其他差异未达到P<0.05的水平。

结论

该登记册已为澳大利亚癫痫孕妇的管理提供了重要信息,但希望有更高的登记率,以使该登记册充分发挥其潜力。

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