Department of Pediatrics, University of Chieti, Chieti, Italy.
Department of Pediatrics, University of L'Aquila, L'Aquila, Italy.
Drug Saf. 2017 Sep;40(9):761-769. doi: 10.1007/s40264-017-0546-x.
Clomiphene citrate (CC) is the oldest drug used to regulate the process of ovulation. Considering the great use of CC over the last 40 years, it is important to understand the possible risks associated with its use. The aim of this review was to evaluate the possible teratogenic effects of CC, analyzing results obtained from animal and human studies. The pharmacokinetics of CC and possible mechanisms involved in teratogenesis are examined. Fetal exposure to CC is possible due to the long half-life of CC and its metabolites. Alarming data have emerged from animal studies, although controversial results come from human studies. There is some evidence regarding a possible association of CC exposure and fetal malformations, mainly neural tube defects and hypospadias, which would require further investigation in order to allow safer use of this useful drug.
枸橼酸氯米酚(CC)是用于调节排卵过程的最古老的药物。考虑到 CC 在过去 40 年中的广泛应用,了解其使用相关的潜在风险非常重要。本综述的目的是评估 CC 的可能致畸作用,分析来自动物和人体研究的结果。本文研究了 CC 的药代动力学及其可能涉及的致畸机制。由于 CC 及其代谢物半衰期长,胎儿可能会接触到 CC。尽管来自人体研究的结果存在争议,但动物研究中出现了一些令人担忧的数据。有一些证据表明 CC 暴露与胎儿畸形之间存在可能的关联,主要是神经管缺陷和尿道下裂,这需要进一步研究,以便更安全地使用这种有用的药物。