Schmitz B, Bergmann L
Neurologische Klinik und Poliklinik, Charité, Campus Virchow-Klinikum, Humboldt-Universität Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Nervenarzt. 2007 Aug;78(8):912-22. doi: 10.1007/s00115-006-2060-8.
Gender aspects are important when assessing the tolerability of antiepileptic drugs (AED). Due to its broad spectrum of action and to the lack of evidence for teratogenicity in monotherapy, lamotrigine (LTG) is an AED of first choice for women with epilepsy with child-bearing potential.
In an observational study over 6 months including 832 women with epilepsy, we evaluated the efficacy and tolerability of LTG in monotherapy and add-on therapy, with a special focus on parameters of particular importance for women including changes in weight, skin, hair, and patterns of menstruation.
Of the treated patients, 94% had seizure reduction of at least 50%. Adverse events occurred in 7.3%; 1% experienced serious adverse events, all of which were reversible. Ninety-six percent continued treatment throughout the observation period, and 83% reported improvement in quality of life by the end of the study. Cognition, functioning at work, and mood improved in 43-54% of patients. In most of them, weight remained stable. Those who were switched from valporate (VPA) or carbamazepine (CPZ) to LTG lost 3.2 kg and 3.1 kg (means), respectively. Many of the women described problems related to menstruation at the beginning of the study: variability in cycle length (31.2%), hypermenorrhea (17.3%), and pains (10%). Skin and hair problems were reported by 18.4% and 17.3%, respectively. There was improvement in all of these aspects at the end of the study, particularly for those women switched from VPA or CBZ to LTG.
In summary, this observational study confirms the good tolerability of LTG with respect to issues particularly relevant to women. More complete elucidation of the correct LTG dosage, which varies widely according to the accompanying medication, will further improve treatment safety.
在评估抗癫痫药物（AED）的耐受性时，性别因素很重要。由于拉莫三嗪（LTG）作用谱广且单药治疗时致畸性缺乏证据，它是有生育潜力的癫痫女性的首选AED。
在一项为期6个月的观察性研究中，纳入832例癫痫女性，我们评估了LTG单药治疗和联合治疗的疗效及耐受性，特别关注对女性尤为重要的参数，包括体重、皮肤、毛发和月经模式的变化。
在接受治疗的患者中，94%的患者癫痫发作减少至少50%。不良事件发生率为7.3%；1%经历了严重不良事件，所有这些事件均可逆转。96%的患者在整个观察期内持续治疗，83%的患者在研究结束时报告生活质量有所改善。43% - 54%的患者认知、工作能力和情绪有所改善。大多数患者体重保持稳定。从丙戊酸盐（VPA）或卡马西平（CPZ）换用LTG的患者分别减重3.2千克和3.1千克（均值）。许多女性在研究开始时描述了与月经相关的问题：月经周期长度变化（31.2%）、月经过多（17.3%）和疼痛（10%）。分别有18.4%和17.3%的患者报告有皮肤和毛发问题。在研究结束时，所有这些方面均有改善，尤其是那些从VPA或CBZ换用LTG的女性。
总之，这项观察性研究证实了LTG在与女性特别相关的问题上具有良好的耐受性。更全面地阐明根据伴随用药情况差异很大的正确LTG剂量，将进一步提高治疗安全性。
