Madjunkova Svetlana, Maltepe Caroline, Koren Gideon
The Motherisk Program, Division of Clinical Pharmacology/Toxicology, Department of Pediatrics, The Hospital for Sick Children and University of Toronto, Toronto, Canada,
Paediatr Drugs. 2014 Jun;16(3):199-211. doi: 10.1007/s40272-014-0065-5.
Nausea and vomiting of pregnancy (NVP) affects up to 85 % of all pregnancies. Effective treatment can greatly improve a woman's quality of life, reduce the risk for maternal and fetal complications, and reduce healthcare costs. Unfortunately, many women receive either no pharmacological treatment or are recommended therapies for which fetal safety and efficacy have not been established. First-line treatment of NVP, as recommended by several leading healthcare and professional organizations, is the combination of doxylamine and pyridoxine. This combination, formulated as a 10 mg/10 mg delayed-release tablet, was approved by the US Food and Drug Administration (FDA) for the treatment of NVP in April 2013 under the brand name Diclegis(®), and has been on the Canadian market since 1979, currently under the brand name Diclectin(®). The efficacy of Diclegis(®)/Diclectin(®) has been demonstrated in several clinical trials, and, more importantly, studies on more than 200,000 women exposed to doxylamine and pyridoxine in the first trimester of pregnancy have demonstrated no increased fetal risk for congenital malformations and other adverse pregnancy outcomes. The present review aims to present the scientific evidence on the effectiveness and fetal safety of Diclegis(®)/Diclectin(®) for the treatment of NVP to justify its use as first-line treatment for NVP.
妊娠恶心和呕吐（NVP）影响着高达85%的妊娠女性。有效的治疗可极大提高女性的生活质量，降低母婴并发症风险，并降低医疗成本。遗憾的是，许多女性要么未接受药物治疗，要么被推荐使用胎儿安全性和有效性尚未确定的疗法。几个主要的医疗保健和专业组织推荐，NVP的一线治疗药物是多西拉敏和吡哆醇的组合。这种组合制成10毫克/10毫克缓释片，于2013年4月获美国食品药品监督管理局（FDA）批准，以Diclegis（®）为商品名用于治疗NVP，自1979年起在加拿大市场销售，目前商品名为Diclectin（®）。Diclegis（®）/Diclectin（®）的疗效已在多项临床试验中得到证实，更重要的是，对超过20万名在妊娠头三个月接触多西拉敏和吡哆醇的女性进行的研究表明，先天性畸形和其他不良妊娠结局的胎儿风险并未增加。本综述旨在介绍Diclegis（®）/Diclectin（®）治疗NVP有效性和胎儿安全性的科学证据，以证明其作为NVP一线治疗药物的合理性。
