Neurology：加巴喷丁不增加妊娠妇女的胎儿出生缺陷发生率

加巴喷丁是一种新型抗癫痫药，其为γ－氨基丁酸（GABA）的衍生物，但对妊娠妇女的影响尚不明确。来自多伦多大学的Hisaki Fujii等学者进行了此方面的研究发表在2013年4月23日的Neurology杂志上。该观察性研究的目的为：1、明确孕早期应用加巴喷丁是否与新生儿重大出生缺陷相关；2、评估自发性流产、治疗性流产、死胎、分娩时的新生儿的平均出生体重及胎龄；3、评估妊娠晚期暴露后新生儿适应不良综合征的发生率。

该研究为前瞻性研究。纳入在5到8周应用加巴喷丁药物的妊娠期妇女，并以相同方法纳入的对照组为没有接触致畸药物的妊娠期妇女。

研究共纳入223例服用加巴喷丁药物的妊娠期妇女并与223非接触妇女对比。两组的主要出生缺陷发生率相似(p = 0.845)。加巴喷丁组早产率 (p = 0.019)及新生儿低出生体重(p = 0.033)发生率较高。加巴喷丁组的婴儿在出生时，61例中有23例(38%)进入新生儿重症监护室或特殊护理观察及治疗，而对照组201例成活新生儿中只有6例(2.9%)需要特殊监护或治疗，两组有明显统计学差异(p < 0.001)。加巴喷丁组婴儿出生时有2例可疑有新生儿适应不良综合征，对照组未见发生，需要说明的是这些婴儿曾接触其他精神药品。服用加巴喷丁组的妇女主要适应症为疼痛 (n = 90; 43%)和癫痫 (n = 71; 34%)，剩余服用者包括其他适应症，主要为精神方面的应用。

研究结果显示，尽管由于样本量的限制，不足够得出任何明确的结论，而且缺乏和其他抗癫痫药物的对比，我们仍然可以推测加巴喷丁的使用并没有增加主要出生缺陷的发生率。至于出生时的低出生体重及早产发生率的增加仍需要进一步的研究。
与加巴喷丁相关的拓展阅读：

• 加巴喷丁新用途：美国批准用于带状疱疹后遗神经痛
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Pregnancy outcomes following gabapentin use: Results of a prospective comparative cohort study.
OBJECTIVES
Our objectives were to 1) determine whether first-trimester use of gabapentin is associated with an increased risk for major malformations; 2) examine rates of spontaneous abortions, therapeutic abortions, stillbirths, mean birth weight and gestational age at delivery; and 3) examine rates of poor neonatal adaptation syndrome following late pregnancy exposure.
METHODS
The study design was prospective. Women were included who initially contacted the services between 5 and 8 weeks with a comparison group of women exposed to nonteratogens, collected in a similar manner.
RESULTS
We have data on 223 pregnancy outcomes exposed to gabapentin and 223 unexposed pregnancies. The rates of major malformations were similar in both groups (p = 0.845). There was a higher rate of preterm births (p = 0.019) and low birth weight <2,500 g (p = 0.033) in the gabapentin group. Among infants who were exposed to gabapentin up until delivery, 23 of 61 (38%) were admitted to either the neonatal intensive care unit or special care nursery for observation and/or treatment, vs 6 of 201 (2.9%) live births in the comparison group (p < 0.001). There were 2 cases of possible poor neonatal adaptation syndrome in neonates exposed to gabapentin close to delivery, compared with none in the comparison group, although it must be noted that these infants were concomitantly exposed to other psychotropic drugs. Among the women who took gabapentin, the major indications were pain (n = 90; 43%) and epilepsy (n = 71; 34%); the remainder were for other indications, mostly psychiatric.
CONCLUSION
Our results suggest that although this sample size is not large enough to make any definitive conclusions, and there was no comparator group treated with other antiepileptic drugs, gabapentin use in pregnancy does not appear to increase the risk for major malformations. This finding and the increased risk for low birth weight and preterm birth require further investigation.