Neurobiology Lab, Department of Zoology, University of Allahabad, Allahabad, India.
Pharmacol Rep. 2019 Jun;71(3):491-502. doi: 10.1016/j.pharep.2019.01.011. Epub 2019 Jan 31.
The aim of this review was to scrutinize the current literature available on teratogenic safety of third-generation antiepileptic drugs (TGAEDs) considering their clinical implications and to highlight for further research need in the interest of the diseased population in general and women with epilepsy in particular. For evaluation of the teratogenic potential of TGAEDs, this review summarized the existing information on controlled clinical trials conducted by the pharmaceutical companies, case reports, scholarly articles (prospective and retrospective studies), and experimental tests carried out so far. Firstly, clinical reports have reviewed on each drug followed by non-clinical studies reported hitherto. The Pub-Med and Google search engine was used to explore the relevant articles with pertinent keywords like pregnancy, epilepsy, seizures, women with epilepsy, antiepileptic or anticonvulsant drugs, first-second/new and third/ newest generation antiepileptic drugs, teratogenicity, teratological potential, birth defects, congenital anomalies, epilepsy and pregnancy registries, malformation surveillance program. The search was also carried out by the individual name of 20 third-generation AEDs. This review declared that although much research has been carried out on clinical and non-clinical implications for the assessment of the teratogenic potential of FGAEDs and SGAEDs, reports on the teratogenic safety of TGAEDs are still limited. It is concluded that there is an urgent need to exaggerate a large number of clinical intervention trials/reports and experimental studies to draw a definite conclusion for the teratogenic safety of TGAEDs. This is a pioneer attempt by our laboratory to review the teratogenic potential of third-generation antiepileptic drugs.
本次综述的目的是仔细审查现有关于第三代抗癫痫药物（TGAED）的致畸安全性的文献，考虑其临床意义，并强调进一步研究的必要性，以造福一般患者群体，尤其是女性癫痫患者。为了评估 TGAED 的致畸潜力，本综述总结了制药公司进行的对照临床试验、病例报告、学术文章（前瞻性和回顾性研究）以及迄今为止进行的实验测试的现有信息。首先，对每种药物的临床报告进行了回顾，然后对迄今为止报告的非临床研究进行了回顾。使用 Pub-Med 和 Google 搜索引擎，使用相关关键词（如怀孕、癫痫、癫痫发作、女性癫痫患者、抗癫痫药或抗惊厥药、第一代/第二代/新型和第三代/最新一代抗癫痫药、致畸性、致畸潜力、出生缺陷、先天畸形、癫痫和妊娠登记处、畸形监测计划）搜索相关文章。还通过 20 种第三代 AED 的个人名称进行了搜索。本综述声明，尽管已经对 FGAED 和 SGAED 的致畸潜在性的临床和非临床影响进行了大量研究，但关于 TGAED 致畸安全性的报告仍然有限。结论是，迫切需要夸大大量的临床干预试验/报告和实验研究，以对 TGAED 的致畸安全性得出明确结论。这是我们实验室首次尝试评估第三代抗癫痫药物的致畸潜力。
