Mazzotta P, Loebstein R, Koren G
Motherisk Program, Division of Clinical Pharmacology and Toxicology, Hospital for Sick Children, University of Toronto, Ontario, Canada.
Drug Saf. 1999 Apr;20(4):361-75. doi: 10.2165/00002018-199920040-00005.
Allergic rhinitis affects approximately one-third of women of childbearing age. As a result, symptoms ranging from sneezing and itching to severe nasal obstruction may require pharmacotherapy. However, product labels state that medications for allergic rhinitis should be avoided during pregnancy due to lack of fetal safety data, even though the majority of the agents have human data which refute these notions. We present a systematic and critical review of the medical literature on the use of pharmacotherapy for the management of allergic rhinitis during pregnancy. Electronic databases and other literature sources were searched to identify observational controlled studies focusing on the rate of fetal malformations in pregnant women exposed to agents used to treat allergic rhinitis and related diseases compared with controls. Immunotherapy and intranasal sodium cromoglycate (cromolyn) and beclo-methasone would be considered as first-line therapy, both because of their lack of association with congenital abnormalities and their superior efficacy to other agents. First-generation (e.g. chlorpheniramine) and second-generation (e.g. cetirizine) antihistamines have not been incriminated as human teratogens. However, first-generation antihistamines are favoured over their second generation counterparts based on their longevity, leading to more conclusive evidence of safety. There are no controlled trials with loratadine and fexofenadine in human pregnancy. Oral, intranasal and ophthalmic decongestants (e.g. pseudoephedrine, phenylephrine and oxymetazoline, respectively) should be considered as second-line therapy, although further studies are needed to clarify their fetal safety. No human reproductive studies have been reported with the ophthalmic antihistamines ketorolac and levocabastine, although preliminary data reported suggest no association between pheniramine and congenital malformations. There are no documented epidemiological studies with intranasal corticosteroids (e.g. budesonide, fluticasone propionate, mometasone) during pregnancy; however, inhaled corticosteroids (e.g. beclomethasone) have not been incriminated as teratogens and are commonly used by pregnant women who have asthma. In summary, women with allergic rhinitis during pregnancy can be treated with a number of pharmacological agents without concern of untoward effects on their unborn child. Although the choice of agents in part should be based on evidence of fetal safety, issue of efficacy needs to be addressed in order to optimally manage this condition.
变应性鼻炎影响着约三分之一的育龄女性。因此，从打喷嚏、瘙痒到严重鼻塞等症状可能需要药物治疗。然而，产品标签表明，由于缺乏胎儿安全性数据，孕期应避免使用变应性鼻炎药物，尽管大多数药物已有反驳这些观点的人体数据。我们对关于孕期使用药物治疗变应性鼻炎的医学文献进行了系统且批判性的综述。检索了电子数据库和其他文献来源，以确定观察性对照研究，该研究聚焦于与对照组相比，暴露于用于治疗变应性鼻炎及相关疾病药物的孕妇中胎儿畸形的发生率。免疫疗法、鼻内色甘酸钠（色甘酸）和倍氯米松将被视为一线治疗方法，这既是因为它们与先天性异常无关，也是因为它们相较于其他药物具有更高的疗效。第一代（如氯苯那敏）和第二代（如西替利嗪）抗组胺药未被认定为人类致畸剂。然而，基于第一代抗组胺药的使用时长，它们比第二代抗组胺药更受青睐，可以得出更确凿的安全性证据。氯雷他定和非索非那定在人类孕期尚无对照试验。口服、鼻内和眼部减充血剂（分别如伪麻黄碱、去氧肾上腺素和羟甲唑啉）应被视为二线治疗方法，不过还需要进一步研究以阐明它们对胎儿的安全性。关于眼部抗组胺药酮咯酸和左卡巴斯汀尚无人体生殖研究报道，尽管已报道的初步数据表明苯海拉明与先天性畸形之间无关联。孕期使用鼻内糖皮质激素（如布地奈德、丙酸氟替卡松、莫米松）尚无记录在案的流行病学研究；然而，吸入性糖皮质激素（如倍氯米松）未被认定为致畸剂，且患有哮喘的孕妇也常用。总之，孕期患有变应性鼻炎的女性可以使用多种药物进行治疗，而无需担心对其未出生的孩子产生不良影响。尽管药物的选择部分应基于胎儿安全性证据，但为了最佳地控制这种情况，还需要考虑疗效问题。
