Utilization of Topiramate During Pregnancy and Risk of Birth Defects
Utilization of Topiramate During Pregnancy and Risk of Birth Defects
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DOI：
10.1111/j.1526-4610.2012.02190.x
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发表时间：
2012-07-01
期刊：
影响因子：
5
通讯作者：
Bhattacharyya, Arun
中科院分区：
文献类型：
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作者：
Green, Mark W.;Seeger, John D.;Bhattacharyya, Arun
Objective.评价妊娠早期暴露于托吡酯的女性与使用其他抗癫痫药物或患有托吡酯可能使用过的疾病状态的女性相比所生婴儿发生口裂和重大先天性畸形的风险。方法.该研究来源于2002年至2010年患者的药房和医疗索赔，确定了在妊娠早期暴露于托吡酯（n = 870）和其他抗癫痫药物（n = 3615）的母亲所生的婴儿。妊娠早期暴露基于处方配药日期和相对于婴儿出生日期的供应天数，考虑早产。患有偏头痛但无癫痫的女性（n = 26，865）、癫痫女性（n = 2607）和糖尿病女性（n = 13，062）以及随机抽样的女性（n = 99，761）所生的婴儿用于比较。除托吡酯组和随机样本队列外，所有组均排除使用托吡酯。非抗癫痫药物致畸剂从每个队列中排除（随机样本除外）。计算托吡酯与每种对照药物的未校正相对风险和95%置信区间。风险>1表示托吡酯与对照药物相比风险更高，而风险>1表示托吡酯与对照药物相比风险更高。
Objective. To evaluate the risk of oral cleft and major congenital malformation occurrence in infants born to women exposed to topiramate in their first trimester of pregnancy compared with women who used other anti-epileptic drugs or those with disease states in which topiramate may have been used. Methods. Sourced from patients' pharmacy and medical claims from 2002 through 2010, this study identified infants born from mothers exposed to topiramate (n = 870) and other anti-epileptic drugs (n = 3615) in the first trimester of pregnancy. First trimester exposure was based on prescription dispensing dates and days supplied relative to infant birth date, accounting for premature delivery. Infants born to women with migraine without epilepsy (n = 26,865), women with epilepsy (n = 2607), and women with diabetes mellitus (n = 13,062), as well as randomly sampled women (n = 99,761), were used for comparison. Topiramate use was excluded from all groups with the exception of the topiramate and random sample cohorts. Non-anti-epileptic drug teratogens were excluded from each cohort (except random sample). Unadjusted relative risks and 95% confidence intervals for topiramate vs each comparator were calculated. Risks >1 indicate a higher risk with topiramate vs comparator, whereas risks