Plomp T A, Vulsma T, de Vijlder J J
Netherlands Institute for Drugs and Doping Research, State University of Utrecht.
Eur J Obstet Gynecol Reprod Biol. 1992 Feb 28;43(3):201-7. doi: 10.1016/0028-2243(92)90174-w.
Five cases are studied in which amiodarone (AM) was given during pregnancy, in two of them also during the breast feeding period, to estimate the risks for adverse effects. We measured the concentrations of AM and its major metabolite desethylamiodarone (DEA) in maternal plasma, cord plasma, infant plasma, placental tissue and breast milk and the thyroid hormones were measured in maternal and neonatal serum. Also, the neonates were examined for AM-associated adverse effects over a period varying from 8 months up to 5 years. We observed a limited maternal-fetal transfer of AM and DEA, while the concentration of DEA in placental tissue is relatively high. Considerable amounts of AM and DEA were present in breast milk. One infant appeared to be hypothyroid, detected by the neonatal thyroid screening. He was treated with triiodothyronine for weeks, until it was clear that the thyroid dysfunction was resolved. The other infants had normal screening results. No effect of the AM medication was observed on growth, liver function or cornea and skin.
although pregnancy and lactation are no absolute contraindications for use of AM, special precautions are necessary. It is unavoidable that in some cases the pregnant mother, and especially her infant, becomes hypothyroid. AM has to be administered in the lowest possible dose, and the maternal and neonatal thyroid function must be controlled as long as the exposure to AM lasts.
研究了5例在孕期使用胺碘酮(AM)的病例,其中2例在哺乳期也使用了该药物,以评估不良反应的风险。我们测定了母体血浆、脐血血浆、婴儿血浆、胎盘组织和母乳中AM及其主要代谢产物去乙基胺碘酮(DEA)的浓度,并测定了母体和新生儿血清中的甲状腺激素。此外,对新生儿在8个月至5年的时间段内进行了与AM相关的不良反应检查。我们观察到AM和DEA的母婴转运有限,而胎盘组织中DEA的浓度相对较高。母乳中存在相当数量的AM和DEA。通过新生儿甲状腺筛查发现1例婴儿甲状腺功能减退。他接受了数周的三碘甲状腺原氨酸治疗,直到甲状腺功能障碍明显缓解。其他婴儿的筛查结果正常。未观察到AM用药对生长、肝功能、角膜和皮肤有影响。
虽然怀孕和哺乳并非使用AM的绝对禁忌证,但仍需采取特殊预防措施。在某些情况下,孕妇尤其是其婴儿不可避免地会出现甲状腺功能减退。必须以尽可能低的剂量给予AM,并且只要暴露于AM持续,就必须控制母体和新生儿的甲状腺功能。