Alsaad Abdulaziz M S, Chaudhry Shahnaz Akthar, Koren Gideon
The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children and University of Toronto, 555 University Ave, Toronto, ON M5G 1X8, Canada; Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON M5S 3M2, Canada; Department of Pharmacology & Toxicology, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children and University of Toronto, 555 University Ave, Toronto, ON M5G 1X8, Canada.
Reprod Toxicol. 2015 Jun;53:45-50. doi: 10.1016/j.reprotox.2015.03.003. Epub 2015 Mar 20.
Topiramate (TPM) is an increasingly used drug during childbearing ages for treatment of epilepsy, migraine, and appetite suppression as well as for off-label indications such as sleep and psychiatric disorders. Presently, while some reports suggested an increased risk of oral cleft (OC), these reports are balanced by studies that could not confirm such association. We conducted a meta-analysis of all studies reporting on women exposed to TPM during pregnancy. Of the 2327 publications reviewed, 6 articles met the inclusion criteria including 3420 patients and 1,204,981 controls. The odd ratio (OR) of OC after the first trimester exposure to TPM exposure was 6.26 (95% confidence interval: 3.13-12.51; P = 0.00001). This study provides strong evidence that TPM is associated with an increased risk of OC in infants exposed to TPM during embryogenesis and should lead to a careful review of TPM use in women of reproductive ages.
托吡酯（TPM）在育龄期越来越多地用于治疗癫痫、偏头痛和抑制食欲，以及用于睡眠和精神疾病等未标明的适应症。目前，虽然一些报告表明口腔腭裂（OC）风险增加，但这些报告被无法证实这种关联的研究所平衡。我们对所有报告孕期接触TPM的女性的研究进行了荟萃分析。在审查的2327篇出版物中，6篇文章符合纳入标准，包括3420例患者和1204981例对照。孕早期接触TPM后发生OC的比值比（OR）为6.26（95%置信区间：3.13 - 12.51；P = 0.00001）。本研究提供了有力证据，表明TPM与胚胎发育期间接触TPM的婴儿患OC风险增加有关，应促使对育龄期女性使用TPM进行仔细审查。
