Montouris Georgia
Boston Medical Center, Boston, MA 02118, USA.
Curr Med Res Opin. 2005 May;21(5):693-701. doi: 10.1185/030079905x43640.
Seizure control in pregnant women with epilepsy is vital, as maternal seizures may have deleterious consequences. The treatment of pregnant women with epilepsy is, however, complicated by the teratogenicity of older antiepileptic drugs (AEDs). In this review, the safety of the newer AED oxcarbazepine during pregnancy is assessed based on published pregnancy outcome data. Other relevant safety issues, such as oxcarbazepine pharmacokinetics during pregnancy and the compatibility of oxcarbazepine treatment with breastfeeding, are also discussed.
Literature searches of the following databases were performed: MEDLINE, EMBASE, eNova, NOWIMA (an internal Novartis Germany database), Derwent Drug File, SciSearch and BIOSIS. Identified publications were examined for original data reporting rates of foetal malformation following maternal exposure to oxcarbazepine as monotherapy or adjunctive therapy.
Relevant publications reporting data from the worldwide Novartis safety database and pregnancy registries or study centres in six countries were identified. A total of 248 pregnancies involving maternal exposure to oxcarbazepine monotherapy and 61 involving adjunctive therapy were reported. There were six malformations among the monotherapy group, equating to a malformation rate of 2.4% (6/248). The malformation rate reported in the general population is 2-4%. There were four malformations associated with oxcarbazepine adjunctive therapy, equating to a malformation rate of 6.6% (4/61).
This literature review suggests that, compared with newborns in the general population, the newborns of women receiving oxcarbazepine monotherapy during pregnancy do not appear to show an increased risk for malformations. However, the number of pregnancies involving maternal exposure to oxcarbazepine identified by this review is not sufficient to draw definitive conclusions. Additional information from large-scale pregnancy registries is required to confirm the safety profile of oxcarbazepine as monotherapy or adjunctive therapy during pregnancy.
癫痫孕妇的癫痫发作控制至关重要，因为母亲癫痫发作可能会产生有害后果。然而， older抗癫痫药物（AEDs）的致畸性使癫痫孕妇的治疗变得复杂。在本综述中，基于已发表的妊娠结局数据评估了新型AED奥卡西平在孕期的安全性。还讨论了其他相关安全问题，如孕期奥卡西平的药代动力学以及奥卡西平治疗与母乳喂养的兼容性。
对以下数据库进行文献检索：MEDLINE、EMBASE、eNova、NOWIMA（德国诺华内部数据库）、德温特药物档案、SciSearch和BIOSIS。检查已识别的出版物，以获取母亲暴露于奥卡西平单药治疗或辅助治疗后胎儿畸形的原始数据报告率。
确定了来自全球诺华安全数据库以及六个国家的妊娠登记处或研究中心的相关出版物。共报告了248例母亲暴露于奥卡西平单药治疗的妊娠和61例辅助治疗的妊娠。单药治疗组中有6例畸形，畸形率为2.4%（6/248）。一般人群中报告的畸形率为2-4%。与奥卡西平辅助治疗相关的有4例畸形，畸形率为6.6%（4/61）。
本综述表明，与一般人群中的新生儿相比，孕期接受奥卡西平单药治疗的女性所生新生儿的畸形风险似乎并未增加。然而，本综述确定的母亲暴露于奥卡西平的妊娠数量不足以得出明确结论。需要来自大规模妊娠登记处的更多信息来确认奥卡西平作为孕期单药治疗或辅助治疗的安全性。
