Pregnancy outcome of women exposed to bupropion during pregnancy: A prospective comparative study
Pregnancy outcome of women exposed to bupropion during pregnancy: A prospective comparative study
复制标题
DOI：
10.1016/j.ajog.2004.09.027
复制
发表时间：
2005-03-01
影响因子：
9.8
通讯作者：
Einarson, A
中科院分区：
文献类型：
--
作者：
Chun-Fai-Chan, B;Koren, G;Einarson, A
目的：安非他酮被开发用于治疗抑郁症，但随后被发现对戒烟有效。到目前为止，还没有前瞻性的比较研究来检验它在怀孕期间的安全性。主要目标是确定安非他酮是否会增加超过基线的重大畸形的风险。第二个目标是检查活产、死产、自然流产和治疗性流产的比率、平均出生体重和出生时胎龄。研究设计：研究对象为怀孕或计划怀孕并服用安非他酮的妇女。妊娠结局随访时间为产后4个月至1年。进行了三项比较：1)服用安非他酮的妇女与非致畸药物组；2)服用抑郁症与其他抗抑郁药物的妇女，与非致畸药物组的妇女；3)自然流产的妇女与服用抑郁症的妇女比较。结果：我们完成了对136名怀孕前三个月服用安非他酮的妇女的随访。活产105例，无重大畸形，平均出生体重3450g，平均胎龄40周，自然流产20例，治疗性流产10例，死产1例，新生儿死亡1例。在暴露组和对照组之间，我们检查的任何终点之间没有统计学上的显著差异，除了安非他酮组明显更多的自然流产(P=0.009)。结论：这些结果表明安非他酮不会增加基线以上的主要畸形率。较高的自然流产率类似于其他研究怀孕期间抗抑郁药安全性的研究。(C)2005 Elsevier Inc.保留所有权利。
Objective: Bupropion was developed for the treatment of depression, but subsequently was found to be effective for smoking cessation. To date, there are no prospective comparative studies examining its safety in pregnancy. The primary objective was to determine whether bupropion increases the risks for major malformations above baseline. The secondary objective was to examine the rates of live births, stillbirths, spontaneous and therapeutic abortions, mean birth weight, and gestational age at birth.Study design: Women who were pregnant or planning a pregnancy and taking bupropion were enrolled in the Study. Follow-up of pregnancy outcome was carried out between 4 months and I year after delivery. Three comparisons were carried Out: 1) women exposed to bupropion vs a nonteratogen group; 2) those taking for depression vs other antidepressants, vs a nonteratogen group; 3) spontaneous abortions were compared between those taking for depression. vs another antidepressant group vs a nonteratogen group.Results: We completed follow-up on 136 women exposed to bupropion during the first trimester of pregnancy. There were (105) live births, no major malformations, the mean birth weight was (3450g), the mean gestational age at delivery was (40 weeks), the number of spontaneous abortions was 20, there were 10 therapeutic abortions, there was 1 stillbirth, and 1 neonatal death. There were no statistically significant differences between any of the end points we examined between the exposed and comparison groups, With the exception of significantly more spontaneous abortions in the bupropion group (P = .009).Conclusion: These results suggest that bupropion does not increase the rates of major malformation above baseline. The higher rates of spontaneous abortions are similar to other studies examining the safety of antidepressants during pregnancy. (C) 2005 Elsevier Inc. All rights reserved.