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- 2017-12-06 发布于广东
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女性癫痫患者的长程管理 CH/KP/1606/0163 女性癫痫概述我国癫痫患病率高达7‰?,约有900万癫痫患者1其中近一半为女性患者23%的癫痫病人为育龄期女性(12-50岁)2中华神经科杂志. 2013; 46(7): 496-499Joint Epilepsy Council of the UK and Ireland (2011)女性癫痫患者需要更多关注中华神经科杂志. 2013; 46(7): 496-499女性癫痫患者的管理EMA有关VPA的黑框警告CEA-ILAE 2015指南更新女性癫痫患者的药物治疗EMA有关丙戊酸(VPA)在具生育潜力女性(包括女童,女性青少年,育龄期及怀孕女性)中使用的黑框警告“ VPA*不应用于女性儿童、女性青少年、具生育潜力的女性以及怀孕的女性,除非其他治疗均无效或不耐受。”欧洲药品管理局(EMA) 2015年更新的 VPA* SmPC: 4.4.1 Special warningsFemale children/Female adolescents/Women of childbearing potential/Pregnancy: Epilim should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated because of its high teratogenic potential and risk of developmental disorders in infants exposed in utero to valproate. The benefit and risk should be carefully reconsidered at regular treatment reviews, at puberty and urgently when a woman of childbearing potential treated with Epilim plans a pregnancy or if she becomes pregnant. Women of childbearing potential must use effective contraception during treatment and be informed of the risks associated with the use of Epilim during pregnancy (see section 4.6). The prescriber must ensure that the patient is provided with comprehensive information on the risks alongside relevant materials, such as a patient information booklet, to support her understanding of the risks. In particular the prescriber must ensure the patient understands: ? The nature and the magnitude of the risks of exposure during pregnancy, in particular the teratogenic risks and the risks of developmental disorders. ? The need to use effective contraception. ? The need for regular review of treatment. ? The need to rapidly consult her physician if she is thinking of becoming pregnant or there is a possibility of pregnancy. In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible (see section 4.6).
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