Antiseizure medications

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What is the risk of hemorrhagic disease in neonates born to WWE taking AS5Co3HiyK6mRk9dYmmxY2D5NpfxTnLdho 结论：没有足够的证据明确服用AEDs的WWE的新生儿发生新生儿出血性疾病的风险增加（一项Ⅱ类研究） 建议：应告知妊娠期或有怀孕计划的WWE，目前没有足够的证据显示服用AEDs与新生儿出血性疾病的风险增加有关（Level U）。 Conclusion: There is insufficient evidence to determine if the risk of neonatal hemorrhagic complications in the newborns of WWE taking AEDs issubstantially increased (one inadequately sensitive Class II study). Recommendation: Counseling of WWE who are pregnant or are contemplating pregnancy should reflect that there is insufficient evidence to support or refute an increased risk of hemorrhagic complications in the newborns of WWE taking AEDs (Level U). Harden CL, Pennell PB, Koppel BS, Hovinga CA, Gidal B, Meador KJ, Hopp J, Ting TY, Hauser WA, Thurman D, Kaplan PW, Robinson JN, French JA, Wiebe S, Wilner AN, Vazquez B, Holmes L, Krumholz A, Finnell R, Shafer PO, Le Guen C; American Academy of Neurology; American Epilepsy Society. Practice parameter update: management issues for women with epilepsy--focus on pregnancy (an evidence-based review): vitamin K, folic acid, blood levels, and breastfeeding: report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society. Neurology. 2009 Jul 14;73(2):142-9. doi: 10.1212/WNL.0b013e3181a6b325. Epub 2009 Apr 27. PMID: 19398680; PMCID: PMC3475193. What is the risk of hemorrhagic disease in neonates born to WWE taking AS5Co3HiyK6mRk9dYmmxY2D5NpfxTnLdho 结论：没有足够的证据明确服用AEDs的WWE的新生儿发生新生儿出血性疾病的风险增加（一项Ⅱ类研究） 建议：应告知妊娠期或有怀孕计划的WWE，目前没有足够的证据显示服用AEDs与新生儿出血性疾病的风险增加有关（Level U）。 Conclusion: There is insufficient evidence to determine if the risk of neonatal hemorrhagic complications in the newborns of WWE taking AEDs issubstantially increased (one inadequately sensitive Class II study). Recommendation: Counseling of WWE who are pregnant or are contemplating pregnancy should reflect that there is insufficient evidence to support or refute an increased risk of hemorrhagic complications in the newborns of WWE taking AEDs (Level U). Harden CL, Pennell PB, Koppel BS, Hovinga CA, Gidal B, Meador KJ, Hopp J, Ting TY, Hauser WA, Thurman D, Kaplan PW, Robinson JN, French JA, Wiebe S, Wilner AN, Vazquez B, Holmes L, Krumholz A, Finnell R, Shafer PO, Le Guen C; American Academy of Neurology; American Epilepsy Society. Practice parameter update: management issues for women with epilepsy--focus on pregnancy (an evidence-based review): vitamin K, folic acid, blood levels, and breastfeeding: report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and American Epilepsy Society. Neurology. 2009 Jul 14;73(2):142-9. doi: 10.1212/WNL.0b013e3181a6b325. Epub 2009 Apr 27. PMID: 19398680; PMCID: PMC3475193.

应在妊娠期监测AEDs血药水平，其中以拉莫三嗪、左乙拉西坦和奥卡西平血药浓度下降最为明显，在妊娠期和产后可能需要剂量调整。 Mauri Llerda JA, Suller Marti A, de la Peña Mayor P, Martínez Ferri M, Poza Aldea JJ, Gomez Alonso J, Mercadé Cerdá JM. The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients. Neurologia. 2015 Oct;30(8):510-7. English, Spanish. doi: 10.1016/j.nrl.2014.08.002. Epub 2015 Jan 21. PMID: 25618222.

女性癫痫患者在产后仍应继续服用AEDs。 8soCfP12Ph19mi914zQaZz2KsGGtcANVhVVfKAnmVRqM 通常建议在产后数周内，逐渐减量至妊娠前水平。 中国医师协会神经内科分会癫(癎)专委会. "妊娠期女性抗癫(癎)药物应用中国专家共识." 中国医师杂志 17.7(2015):969-971. 绝经期女性癫痫患者的骨质疏松问题也不容忽视，老龄、绝经和部分AEDs的不良反应都是骨质疏松发生的原因。因此，对更年期癫痫女性推荐应用无肝酶诱导作用的AEDs。并且对长期服用AEDs的绝经期及绝经后癫痫女性常规监测骨密度，鼓励其改变生活习惯来预防和阻止骨质疏松的发展，如适度增加体育锻炼；补充钙剂及维生素D；此外二膦酸盐、降钙素、雷洛昔芬都是可能的有效选择。 "关于成人癫痫患者长程管理的专家共识." 中华神经科杂志 .07(2013):496-499. 几乎所有AEDs都可通过血液进入母乳，使接受母乳喂养的婴儿间接获得AEDs。但目前普遍认为母乳喂养利大于弊，故提倡母乳喂养。母乳中AEDs浓度既受母亲血药浓度的影响，也受AEDs母乳通过率的影响，故母亲在哺乳期应服用可控制癫痫发作的AEDs最小剂量，同时应选择母乳通过率较低的药物以降低对婴儿的影响，如拉莫三嗪、氯巴占、奥卡西平等。 "关于成人癫痫患者长程管理的专家共识." 中华神经科杂志 .07(2013):496-499.

生育期女性癫痫患者应向癫痫专科医生和产科医生进行孕前咨询，了解与癫痫相关的妊娠并发症和AEDs可能存在的致畸作用，以便依据个体情况对是否怀孕做出选择。 中国医师协会神经内科分会癫(癎)专委会. "妊娠期女性抗癫(癎)药物应用中国专家共识." 中国医师杂志 17.7(2015):969-971. 如果患者最近两至三年均无发作，且脑电图正常，在告知癫痫复发对患者及胎儿的影响后，可以考虑逐步停药。否则，应当对病情进行综合评估，并依据患者的癫痫发作类型，选取最小剂量AEDs控制发作，并尽可能采取单药治疗方案。 中国医师协会神经内科分会癫(癎)专委会. "妊娠期女性抗癫(癎)药物应用中国专家共识." 中国医师杂志 17.7(2015):969-971. 建议：(1)所有AEDs调整最好在受孕前完成；(2)尽量在癫痫发作控制稳定后开始备孕，尤其是对于全身强直阵-挛性发作患者；(3)尽可能避免使用丙戊酸、扑痢酮、苯巴比妥等；(4)尽量将AEDs调整至单药治疗的最低有效剂量。 中国医师协会神经内科分会癫(癎)专委会. "妊娠期女性抗癫(癎)药物应用中国专家共识." 中国医师杂志 17.7(2015):969-971. 目前临床所使用的AEDs几乎都能透过胎盘屏障。一些AEDs如苯巴比妥、扑痫酮可在胎儿体内蓄积，可能会增加胎儿发生各类先天畸形的风险。 中国医师协会神经内科分会癫(癎)专委会. "妊娠期女性抗癫(癎)药物应用中国专家共识." 中国医师杂志 17.7(2015):969-971. 妊娠早期服用AEDs对胎儿影响最大。 中国医师协会神经内科分会癫(癎)专委会. "妊娠期女性抗癫(癎)药物应用中国专家共识." 中国医师杂志 17.7(2015):969-971. 女性癫痫患者在产后仍应继续服用AEDs。 8soCfP12Ph19mi914zQaZz2KsGGtcANVhVVfKAnmVRqM 通常建议在产后数周内，逐渐减量至妊娠前水平。 中国医师协会神经内科分会癫(癎)专委会. "妊娠期女性抗癫(癎)药物应用中国专家共识." 中国医师杂志 17.7(2015):969-971.

孕前咨询：告知患者癫痫发作及AEDs对妊娠及胎儿风险。妊娠期使用AEDs可能对癫痫女性后代智力发育造成影响，尤其是苯巴比妥和丙戊酸。目前尚无足够的证据来评估新型AEDs（加巴喷丁、左乙拉西坦、噻加宾、托吡酯、氨己烯酸）的致畸性。大剂量丙戊酸（超过800mg/天）以及联合丙戊酸的多药治疗的致畸风险明显增加；告知患者补充叶酸和维生素K的必要性。如果孕妇或者配偶有癫痫疾病，尤其是有特发性癫痫及癫痫及相关遗传病家族史者，应当进行遗传咨询。 Li, S. and Hong, Z., 2015. Lin chuang zhen liao zhi nan. Beijing: Ren min wei sheng chu ban she. 妊娠：孕妇除定期进行产科检查外，还应定期就诊于癫痫专科医生；根据临床发作情况及时调整AEDs的剂量，尽量减少和避免发作，尤其是全面性强直-阵挛发作。孕妇也需要了解，没有证据表明局灶性、失神以及肌阵挛性发作会影响妊娠期与发育阶段的胎儿，除非患者跌倒或者受到了伤害；如果妊娠期间发作控制不佳，要充分考虑到妊娠相关因素的影响，如剧烈呕吐、依从性差等；妊娠16-20周时应该对胎儿进行详细的超声波检查，及时发现可能存在的畸形。 Li, S. and Hong, Z., 2015. Lin chuang zhen liao zhi nan. Beijing: Ren min wei sheng chu ban she. 分娩：应当由产科医师与癫痫专科医师共同诊疗妊娠的癫痫患者。大部分癫痫产妇都能正常分娩，但是疼痛、压力、睡眠不足、过度换气等因素都增加了分娩期发作的危险；建议应当在配备有孕妇及新生儿复苏条件，以及紧急处理母亲癫痫发作的相应专业人士、设备的产科监护室内进行；分娩过程中及分娩后应该按时、按量服用AEDs，如果不能及时口服AEDs，应该通过其他途径给予足量AEDs；在分娩过程中，一旦出现癫痫发作，应该尽快采取措施终止发作，可选用地西泮或劳拉西泮静脉注射；如果发作持续，应该按照癫痫持续状态处理；同时采取措施尽快结束分娩，并作好新生儿抢救准备。 哺乳：绝大多数AEDs可以通过乳汁分泌，但是乳汁中AEDs的浓度相对比较低；对于绝大多数服用AEDs的妇女来说，哺乳相对是安全的，应当鼓励母乳喂养；注意婴儿的不良反应，如易激惹、睡眠不良、体重减轻或镇静、肌张力降低、吸吮无力、进食困难等现象。 Li, S. and Hong, Z., 2015. Lin chuang zhen liao zhi nan. Beijing: Ren min wei sheng chu ban she.

抗癫痫药物

Antiseizure medications

Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.

Be aware of the latest data on the risks to the unborn child associated with AED therapy when prescribing for women and girls of present and future childbearing potential.[2012] 在为当前和未来有生育能力的妇女和女孩开处方时，请注意有关与 AED 治疗对胎儿风险的最新数据。[2012] Refer to the SPC and BNF for individual drug advice on the interactions between AEDs and hormonal replacement and contraception.[new 2012] 有关 AED 与激素替代或避孕之间相互作用的个别药物建议，请参阅 SPC 和 BNF。[2012 年新] nice.org.uk/guidance/cg137

Antiseizure medications

与GBP、LTGT和PM等新型AEDs相比，传统AEDs（PTH、PB、CBZ、VPA）并不会大量转移到母乳中（Level Ⅱ-Ⅲ）。 First-generation AEDs (PTH, PB, CBZ, and VPA) are not transferred into breast milk in clinically significant amounts, in contrast with GBP, LTG, and TPM16 (LE II-III). Experience with novel AEDs is limited. Mauri Llerda JA, Suller Marti A, de la Peña Mayor P, Martínez Ferri M, Poza Aldea JJ, Gomez Alonso J, Mercadé Cerdá JM. The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients. Neurologia. 2015 Oct;30(8):510-7. English, Spanish. doi: 10.1016/j.nrl.2014.08.002. Epub 2015 Jan 21. PMID: 25618222.

如果患者生殖内分泌功能障碍与所服用的AEDs有关，应考虑更换另一种AEDs。 If the cause of the problem is associated with one AED, an alternative treatment with another AED should be designed. 妊娠期AEDs水平可能会发生波动，已观察到PHT、CBZ和LTG清除率增加，且存在较大的个体差异，因此专家建议至少每季度监测一次这些AEDs血药浓度（experts recommend monitoring those levels at least quarterly）。条件允许的话，也可以对LEV和OXC的血药浓度（剂量）进行控制。 Plasma levels of AEDs can change during pregnancy. Increased clearance of PHT, CBZ, and LTG with considerable inter-individual variability is observed, so experts recommend monitoring those levels at least quarterly. Controlling plasma levels or adjusting doses of LEV and OXC is also needed when possible. Mauri Llerda JA, Suller Marti A, de la Peña Mayor P, Martínez Ferri M, Poza Aldea JJ, Gomez Alonso J, Mercadé Cerdá JM. The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients. Neurologia. 2015 Oct;30(8):510-7. English, Spanish. doi: 10.1016/j.nrl.2014.08.002. Epub 2015 Jan 21. PMID: 25618222. 分娩后2-3周应检查血浆药物浓度。若妊娠期间调整了AEDs剂量，产后应再次调整剂量，尤其是需要哺乳的患者。妊娠期使用PRM、OXC和LTG的患者，应立即监测（In cases of treatment with PRM, OXC, and LTG, monitor immediately）。 Plasma levels should be checked 2 to 3 weeks after childbirth. If doses were changed during pregnancy, they should be adjusted again, especially if patient is breastfeeding. In cases of treatment with PRM, OXC, and LTC, monitor immediately. Mauri Llerda JA, Suller Marti A, de la Peña Mayor P, Martínez Ferri M, Poza Aldea JJ, Gomez Alonso J, Mercadé Cerdá JM. The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients. Neurologia. 2015 Oct;30(8):510-7. English, Spanish. doi: 10.1016/j.nrl.2014.08.002. Epub 2015 Jan 21. PMID: 25618222. 癫痫发作频率可能在以下3个阶段中增加：围产期（最常见）、排卵期以及黄体缺陷（无排卵）周期的后半段（in the second half of the cycle during a defective (anovulatory) luteal phase）。 Epileptic seizure frequency may be higher in any of 3 phases: perimenstrual (the most frequent), periovulatory, and in the second half of the cycle during a defective (anovulatory) luteal phase. Mauri Llerda JA, Suller Marti A, de la Peña Mayor P, Martínez Ferri M, Poza Aldea JJ, Gomez Alonso J, Mercadé Cerdá JM. The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients. Neurologia. 2015 Oct;30(8):510-7. English, Spanish. doi: 10.1016/j.nrl.2014.08.002. Epub 2015 Jan 21. PMID: 25618222. the recommendations for Catamenial epilepsy 增加经前期和排卵期的AEDs剂量（Increase the AED dose during perimenstrual and ovulatory phases）。 Increase the AED dose during perimenstrual and ovulatory phases. 经前期和排卵期（perimenstrual and ovulatory phases）使用乙酰唑胺（acetazolamide）250mg/d。 Use acetazolamide dosed at 250 mg/day during the perimenstrual and ovulatory phases. 开始使用激素类避孕药；对于无排卵周期的患者，应在妇科医生的建议和监督下使用激素替代疗法（黄体酮）。 Start hormone contraceptives, and for patients with anovulatory cycles, hormone replacement therapy (progesterone), always with the supervision of a gynaecologist. Mauri Llerda JA, Suller Marti A, de la Peña Mayor P, Martínez Ferri M, Poza Aldea JJ, Gomez Alonso J, Mercadé Cerdá JM. The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients. Neurologia. 2015 Oct;30(8):510-7. English, Spanish. doi: 10.1016/j.nrl.2014.08.002. Epub 2015 Jan 21. PMID: 25618222.

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