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妊娠和哺乳期使用拉科酰胺的情况。

Lacosamide during pregnancy and breastfeeding.

作者信息

Lattanzi Simona, Cagnetti Claudia, Foschi Nicoletta, Provinciali Leandro, Silvestrini Mauro

机构信息

Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, Italy.

Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona, Italy.

出版信息

Neurol Neurochir Pol. 2017 May-Jun;51(3):266-269. doi: 10.1016/j.pjnns.2017.03.003. Epub 2017 Mar 30.

DOI:10.1016/j.pjnns.2017.03.003
PMID:28385340
Abstract

BACKGROUND

The epilepsy treatment during pregnancy represents a balance between teratogenic hazard and seizure control. The aim of the study was to evaluate the safety and efficacy of lacosamide (LCS) during pregnancy and breastfeeding.

METHODS

Patients referred to our Epilepsy Center for pregnancy planning who became pregnant while taking LCS were prospectively followed-up. Data on seizure frequency, side effects, pregnancy course, delivery and breastfeeding, birth outcome, congenital malformation and development of newborns were collected.

RESULTS

Three cases of maternal exposure to LCS were reported. Treatment with LCS was continued throughout pregnancy and breastfeeding at a median daily dose of 400mg. Lacosamide was used as monotherapy in two patients and as add-on treatment in one woman. Seizure frequency did not change throughout pregnancy and two subjects remained seizure free. The median gestational age at delivery was 39 weeks. The median Apgar scores at 1 and 5min were 9 and 10, respectively; no major or minor congenital malformations were observed in the offspring. Normal developmental milestone were reached by all new-borns.

CONCLUSIONS

Worldwide pregnancy registries have provided consistent and increasing information about the efficacy and safety of the older antiepileptic drugs during gestation, while data are lacking for many of the newer generations. These cases could suggest a good level of efficacy and safety for LCS throughout pregnancy and breastfeeding and argue against teratogenic or toxic potentialities.

摘要

背景

孕期癫痫治疗需要在致畸风险和癫痫控制之间取得平衡。本研究的目的是评估拉考沙胺(LCS)在孕期和哺乳期的安全性和有效性。

方法

前瞻性随访那些因计划怀孕而转诊至我们癫痫中心且在服用LCS期间怀孕的患者。收集癫痫发作频率、副作用、妊娠过程、分娩及哺乳情况、出生结局、先天性畸形以及新生儿发育等方面的数据。

结果

报告了3例母亲暴露于LCS的病例。整个孕期及哺乳期均持续使用LCS治疗,中位日剂量为400mg。2例患者将LCS作为单一疗法使用,1例女性将其作为附加治疗。整个孕期癫痫发作频率未改变,2例患者无癫痫发作。分娩时的中位孕周为39周。出生后1分钟和5分钟时的中位阿氏评分分别为9分和10分;后代未观察到重大或轻微先天性畸形。所有新生儿均达到正常发育里程碑。

结论

全球范围内的妊娠登记处已提供了关于 older抗癫痫药物在妊娠期有效性和安全性的一致且不断增加的信息,而许多新一代药物的数据则较为缺乏。这些病例提示LCS在整个孕期和哺乳期具有较好的有效性和安全性,且不存在致畸或毒性潜力。

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