The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study
The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study
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DOI：
10.1111/j.1471-0528.2004.00236.x
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发表时间：
2004-09-01
影响因子：
5.8
通讯作者：
Koren, G
中科院分区：
文献类型：
--
作者：
Einarson, A;Maltepe, C;Koren, G
目的昂丹司琼（枢复宁）是一种治疗癌症化疗所致恶心呕吐的药物。尽管它不是指征，但女性正在处方这种药物用于治疗妊娠恶心和呕吐（NVP）。关于该适应症的胎儿安全性的信息很少。本研究的目的是确定这种药物是否增加基线率的主要malformations.Design一个前瞻性的比较观察study.Setting致畸剂信息服务（TIS）.Population Pregnant women.Methods我们的三组包括妇女谁是暴露于昂丹司琼和妇女暴露于（1）其他止吐药和（2）非致畸剂暴露。所有的妇女都打电话给我们的NVP帮助热线或TIS在母亲风险计划在多伦多，加拿大，或母亲安全计划在悉尼，Australia.Main结局措施率重大malformation.Results我们已经完成了176妊娠结局在每组。在昂丹司琼队列中，有169例活产，5例流产，2例治疗性流产，6例（3.6%）严重畸形，平均出生体重为3362 g [SD 525]。有没有统计学差异，在任何的研究终点之间的昂丹司琼和comparison groups.Conclusions这种药物并没有出现（虽然样本量是有限的）与高于基线的主要畸形的风险增加。
Objective Ondansetron (Zofran) is a drug used for the treatment of nausea and vomiting caused by cancer chemotherapy. Despite the fact that it is not indicated, women are being prescribed this drug for the treatment of nausea and vomiting of pregnancy (NVP). There is a paucity of information on fetal safety for this indication. The objective of this study is to determine whether this drug increases the baseline rate of major malformations.Design A prospective comparative observational study.Setting Teratogen Information Services (TIS).Population Pregnant women.Methods Our three groups included women who were exposed to ondansetron and women exposed to (1) other anti-emetics and (2) non-teratogen exposures. All of the women called either our NVP Helpline or TIS at The Motherisk Program in Toronto, Canada, or The Mothersafe Program in Sydney, Australia.Main outcome measure Rates of major malformation.Results We have completed 176 pregnancy outcomes in each group. In the ondansetron cohort, there were 169 live births, 5 miscarriages, 2 therapeutic abortions, 6 (3.6%) major malformations and the mean birthweight was 3362 g [SD 525]. There were no statistical differences in any of the study endpoints between the ondansetron and the comparison groups.Conclusions This drug does not appear (although the sample size is limited) to be associated with an increased risk for major malformations above baseline.