Crettenand M, Rossetti A O, Buclin T, Winterfeld U
Faculté de biologie et de médecine, Ecole de médecine, Université de Lausanne, Lausanne, Schweiz.
Département des Neurosciences Cliniques, Centre Hospitalier Universitaire Vaudois (CHUV), Université de Lausanne, Lausanne, Schweiz.
Nervenarzt. 2018 Aug;89(8):913-921. doi: 10.1007/s00115-018-0496-2.
Knowledge about the passage of various antiepileptic drugs into breast milk and its consequences for the infant is limited. Faced with this uncertainty, breastfeeding is often discouraged for these patients. The aim of this study was to comprehensively review the available data regarding antiepileptic drugs during breastfeeding, to compare these data with information provided by the summary of product characteristics (SmPCs), and to provide recommendations for the use of these drugs in breastfeeding women.
We performed a systematic literature review on breastfeeding data for 23 antiepileptic drugs. A breastfeeding compatibility score was developed and validated. The estimated score based on the literature review was compared with the estimated score based on recommendations provided by the SmPCs.
We identified 75 articles containing exposure and safety data for 15 antiepileptic agents during breastfeeding. The comparison between the score values based on the literature review and on the SmPCs revealed a very low degree of concordance (weighted kappa: 0.08).
Phenobarbital, primidone, carbamazepine, valproate and levetiracetam are probably compatible with breastfeeding. Treatment with phenytoin, ethosuximide, clonazepam, oxcarbazepine, vigabatrin, topiramate, gabapentin, pregabalin, lamotrigine and zonisamide can be authorized during breastfeeding, provided breastfed infants are carefully monitored for side effects. Since data on the use of mesuximide, clobazam, rufinamide, felbamate, lacosamide, sultiame, perampanel and retigabine are insufficient to adequately assess the risk for breastfed infants, use in breastfeeding women is in principle not recommended and should be carefully evaluated on a case by case basis. In practice, a risk-benefit analysis should be performed for each mother under antiepileptic treatment wishing to breastfeed her child, so that individual risk factors can adequately be taken into account when counseling the patient.
关于各种抗癫痫药物进入母乳的情况及其对婴儿的影响，相关知识有限。面对这种不确定性，这些患者通常不鼓励母乳喂养。本研究的目的是全面回顾母乳喂养期间抗癫痫药物的现有数据，将这些数据与产品特性摘要（SmPCs）提供的信息进行比较，并为哺乳期妇女使用这些药物提供建议。
我们对23种抗癫痫药物的母乳喂养数据进行了系统的文献综述。制定并验证了母乳喂养兼容性评分。将基于文献综述的估计评分与基于SmPCs提供的建议的估计评分进行比较。
我们确定了75篇包含15种抗癫痫药物在母乳喂养期间暴露和安全性数据的文章。基于文献综述和SmPCs的评分值比较显示一致性程度非常低（加权kappa值：0.08）。
苯巴比妥、扑米酮、卡马西平、丙戊酸盐和左乙拉西坦可能与母乳喂养兼容。在母乳喂养期间，若对母乳喂养的婴儿仔细监测副作用，苯妥英、乙琥胺、氯硝西泮、奥卡西平、vigabatrin、托吡酯、加巴喷丁、普瑞巴林、拉莫三嗪和唑尼沙胺的治疗可获批准。由于关于甲琥胺、氯巴占、卢非酰胺、非氨酯、拉科酰胺、舒噻美、吡仑帕奈和瑞替加滨使用的数据不足以充分评估对母乳喂养婴儿的风险，原则上不建议哺乳期妇女使用，应根据具体情况仔细评估。在实践中，应对每位接受抗癫痫治疗且希望母乳喂养孩子的母亲进行风险效益分析，以便在为患者提供咨询时充分考虑个体风险因素。
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