A multicentre prospective controlled study to determine the safety of trazodone and nefazodone use during pregnancy
A multicentre prospective controlled study to determine the safety of trazodone and nefazodone use during pregnancy
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DOI：
10.1177/070674370304800207
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发表时间：
2003-03-01
影响因子：
4
通讯作者：
Koren, Gideon
中科院分区：
文献类型：
--
作者：
Einarson, Adrienne;Bonari, Lori;Koren, Gideon
目的：曲唑酮和奈法唑酮均为苯基哌嗪类抗抑郁药。目前，还没有关于这些药物对胎儿安全性的充分、良好对照的研究。我们的主要目的是确定妊娠期间使用曲唑酮或奈法唑酮是否与重大畸形风险增加相关。次要结果的兴趣包括自发性和治疗性流产率，早产率，和birth weight.Methods：孕妇从5个中心谁曾接触到这些药物（n = 147）在他们的第一个三个月参加了这项研究。我们将这些妇女与服用其他抗抑郁药物（n = 147）或非致畸药物（n = 147）的两组妇女进行了比较。结果：共随访147例，随访时间为10个月。有121例（82.4%）活产，20例（13.6%）自然流产，6例（4%）治疗性流产。在活产婴儿中，有2例（1.6%）严重畸形。在所有情况下，药物暴露发生在妊娠早期，52（35%）的妇女在整个妊娠期间使用这些药物。出生时平均胎龄为38周（SD 4.2），平均出生体重为3306.34 g（SD 655）。我们发现3组之间在我们检查的任何感兴趣的终点方面均无统计学显著差异。样本中，58名妇女暴露于曲唑酮，89人暴露于nefazodone.Conclusion：我们的研究结果表明，这些药物不会增加以上的基线率1%至3%的主要畸形率。
Objectives: Trazodone and nefazodone are phenylpiperazine antidepressants. Currently, there are no adequate, well-controlled studies on the fetal safety of these drugs. Our primary objective was to determine whether the use of trazodone or nefazodone during pregnancy is associated with an increased risk for major malformations. Secondary outcomes of interest included rates of spontaneous and therapeutic abortions, rates of premature labour, and birth weight.Methods: Pregnant women from 5 centres who had been exposed to these drugs (n = 147) were enrolled in the study during their first trimester. We compared the women with 2 groups of women who took either other antidepressant drugs (n = 147) or nonteratogenic drugs (n = 147). All the women were followed up after delivery to ascertain pregnancy outcome and the health of the babyResults: We have completed 147 follow-ups. There were 121 (82.4%) live births, 20 (13.6%) spontaneous abortions, and 6 (4%) therapeutic abortions. Of the live births, there were 2 (1.6%) major malformations. In all cases, drug exposure occurred during the first trimester, with 52 (35%) of the women using these drugs throughout pregnancy. The mean gestational age at birth was 38 weeks (SD 4.2), and the mean birth weight was 3306.34 g (SD 655). We found no statistically significant differences among the 3 groups in any of the endpoints of interest that we examined. Of the sample, 58 women were exposed to trazodone, and 89 were exposed to nefazodone.Conclusion: Our results suggest that these drugs do not increase the rates of major malformations above the baseline rate of 1% to 3%.