Seto A, Einarson T, Koren G
Department of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.
Am J Perinatol. 1997 Mar;14(3):119-24. doi: 10.1055/s-2007-994110.
To determine the relative risk for major malformations associated with antihistamine (H1 blockers) exposure in the first trimester of pregnancy, a literature search of all studies examining the association between antihistamines and major malformations for the period 1960 to 1991 was conducted, followed by meta-analysis. Odds ratio was calculated using the Mantel-Haenszel method. Twenty-four controlled studies met the inclusion criteria with more than 200,000 participating women. The summary odds ratio of major malformations associated with antihistamines taken during the first trimester was 0.76 (95% CI: 0.60-0.94). This analysis indicates that H1 blockers used mainly for morning sickness during the first trimester do not increase the teratogenic risk in humans and may, in fact, be associated with a protective effect. More study is needed to verify the possibility that by preventing vomiting, antihistamines may ensure better metabolic conditions to the fetus and thus may reduce some birth defects. Alternatively, it is possible that pregnancies characterized by vomiting are associated with better outcome due to other reasons, such as hormonal status or placental function. Women suffering from morning sickness which is not controlled by nonpharmacological methods can safely use antihistamines.
为了确定妊娠早期接触抗组胺药（H1受体阻滞剂）与严重畸形的相对风险，我们检索了1960年至1991年期间所有研究抗组胺药与严重畸形之间关联的文献，随后进行了荟萃分析。采用Mantel-Haenszel方法计算比值比。24项对照研究符合纳入标准，参与研究的女性超过20万。妊娠早期服用抗组胺药与严重畸形的汇总比值比为0.76（95%可信区间：0.60 - 0.94）。该分析表明，妊娠早期主要用于治疗孕吐的H1受体阻滞剂不会增加人类的致畸风险，实际上可能具有保护作用。需要更多研究来证实抗组胺药通过预防呕吐可能为胎儿确保更好的代谢条件从而减少某些出生缺陷的可能性。或者，以呕吐为特征的妊娠可能由于其他原因（如激素状态或胎盘功能）而有更好的结局。患有非药物方法无法控制的孕吐的女性可以安全使用抗组胺药。
