Motherisk Program, Department of Pediatrics, The Hospital for Sick Children, The University of Toronto, Canada.
Neurology. 2013 Apr 23;80(17):1565-70. doi: 10.1212/WNL.0b013e31828f18c1. Epub 2013 Apr 3.
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.
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.
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.
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.
我们的目的是：1）确定孕早期使用加巴喷丁是否会增加重大畸形的风险；2）检查自然流产、治疗性流产、死产、平均出生体重和分娩时的胎龄；3）检查晚期妊娠暴露后新生儿适应不良综合征的发生率。
研究设计为前瞻性。我们纳入了在妊娠 5-8 周期间首次联系服务的女性，并收集了类似方式暴露于非致畸物的对照组女性的数据。
我们有 223 例暴露于加巴喷丁的妊娠结局和 223 例未暴露的妊娠数据。两组的重大畸形发生率相似（p = 0.845）。加巴喷丁组的早产率较高（p = 0.019），出生体重较低（<2,500 g）（p = 0.033）。在直至分娩时暴露于加巴喷丁的婴儿中，61 例中有 23 例（38%）因观察和/或治疗而被收入新生儿重症监护室或特殊护理病房，而对照组的 201 例活产儿中仅有 6 例（2.9%）（p < 0.001）。在接近分娩时暴露于加巴喷丁的新生儿中有 2 例可能出现新生儿适应不良综合征，而对照组中则没有，但必须注意的是，这些婴儿同时还暴露于其他精神药物。在服用加巴喷丁的女性中，主要指征是疼痛（n = 90；43%）和癫痫（n = 71；34%）；其余为其他指征，主要是精神科。
我们的结果表明，尽管这个样本量还不足以得出任何明确的结论，并且没有与其他抗癫痫药物治疗的对照组进行比较，但妊娠期间使用加巴喷丁似乎不会增加重大畸形的风险。这一发现以及低出生体重和早产的风险增加需要进一步研究。
