Bánhidy Ferenc, Acs Nándor, Puhó Erzsébet H, Czeizel Andrew E
Second Department of Obstetrics and Gynecology, Semmelweis, University, School of Medicine, Budapest, Hungary.
Congenit Anom (Kyoto). 2010 Jun;50(2):122-8. doi: 10.1111/j.1741-4520.2010.00276.x. Epub 2010 Feb 22.
Pholedrine was a frequently used drug for the treatment of severe hypotension in some countries, including Hungary. The possible teratogenic effect of pholedrine was not checked; therefore; the birth outcomes, particularly congenital abnormalities (CAs), of infants born to women treated with pholedrine during pregnancy, and pregnancy complications were evaluated in the population-based large dataset of the Hungarian Case-Control Surveillance System of Congenital Abnormalities. Cases with CA and their matched controls without CA born to mothers with pholedrine use during pregnancy were compared. Of 22 843 cases and 38 151 controls, 768 (3.4%) and 1509 (4.0%) were born to mothers with pholedrine treatment, respectively (adjusted odds ratios [OR] with 95% CI: 0.9, 0.8-1.0). There was no higher risk for any CA group in the offspring of mothers who used pholedrine during the second and/or third month of pregnancy (i.e. the critical period of most major CA). The mean gestational week at delivery and birthweight was similar in newborns of women with or without pholedrine treatment during pregnancy. The pattern of pregnancy complications was characteristic (lower incidence of preeclampsia/eclampsia, while higher incidence of severe nausea/vomiting and anemia), explained mainly by the underlying maternal hypotension. In conclusion, pholedrine treatment in pregnant women was not associated with a higher risk for CA or other adverse birth outcomes, such as preterm birth or low birthweight. The knowledge of the teratogenic potential of pholedrine may contribute to the evaluation of other sympathomimetic drugs.
在包括匈牙利在内的一些国家，福来君是治疗严重低血压的常用药物。福来君的潜在致畸作用未得到检验；因此，在匈牙利先天性异常病例对照监测系统的基于人群的大型数据集中，对孕期接受福来君治疗的妇女所生婴儿的出生结局，尤其是先天性异常（CA）以及妊娠并发症进行了评估。比较了孕期使用福来君的母亲所生的患有CA的病例及其匹配的无CA的对照。在22843例病例和38151例对照中，分别有768例（3.4%）和1509例（4.0%）是由接受福来君治疗的母亲所生（校正比值比[OR]及95%可信区间：0.9，0.8 - 1.0）。在妊娠第二和/或第三个月（即大多数主要CA的关键期）使用福来君的母亲的后代中，任何CA组的风险均未升高。孕期接受或未接受福来君治疗的妇女所生新生儿的平均孕周和出生体重相似。妊娠并发症的模式具有特征性（先兆子痫/子痫的发生率较低，而严重恶心/呕吐和贫血的发生率较高），这主要由潜在的母亲低血压所解释。总之，孕妇使用福来君治疗与CA或其他不良出生结局（如早产或低出生体重）的较高风险无关。了解福来君的致畸潜力可能有助于评估其他拟交感神经药物。
