Loder Elizabeth
Harvard Medical School, Boston, Massachusetts, USA.
CNS Drugs. 2003;17(1):1-7. doi: 10.2165/00023210-200317010-00001.
The high prevalence of migraine in women during their reproductive years means that new drug treatments for migraine, such as the serotonin 5-HT(1B/1D) receptor agonists (the 'triptans'), are likely to be widely used by women of childbearing potential. Scrutiny of these agents in an effort to detect any signal of teratogenicity is thus important. A systematic review of the medical literature was conducted to identify information regarding the safety of sumatriptan during pregnancy. This agent was chosen to be investigated because it has been available for the longest and is the most widely used of the triptan class. Information was obtained regarding the impact of migraine on pregnancy outcome, and data on sumatriptan use in pregnancy were obtained from animal studies, preclinical drug trials, postmarketing surveillance efforts, prospective pregnancy registries, national birth registries and teratogen information services. Synthesis of information from these sources is sufficient to rule out a large increase in birth defects from sumatriptan use during pregnancy and is reassuring for cases where inadvertent exposure to sumatriptan during pregnancy has occurred. However, current information is not sufficient to rule out small increases in the risk for birth defects. For this reason, caution should be exercised in making a positive recommendation for the use of sumatriptan during pregnancy.
偏头痛在育龄女性中高发，这意味着偏头痛的新型药物治疗方法，如5-羟色胺5-HT(1B/1D)受体激动剂（“曲坦类药物”），很可能会被有生育潜力的女性广泛使用。因此，仔细审查这些药物以检测任何致畸信号非常重要。我们对医学文献进行了系统综述，以确定有关舒马曲坦在孕期安全性的信息。选择该药物进行研究是因为它上市时间最长，也是曲坦类药物中使用最广泛的。我们获取了有关偏头痛对妊娠结局影响的信息，以及孕期使用舒马曲坦的数据，这些数据来自动物研究、临床前药物试验、上市后监测、前瞻性妊娠登记、国家出生登记和致畸信息服务。综合这些来源的信息足以排除孕期使用舒马曲坦导致出生缺陷大幅增加的可能性，对于孕期意外接触舒马曲坦的情况也令人安心。然而，目前的信息不足以排除出生缺陷风险的小幅增加。因此，在积极推荐孕期使用舒马曲坦时应谨慎。
