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昂丹司琼在西澳大利亚州孕期的超说明书用药情况。

Off-label use of ondansetron in pregnancy in Western Australia.

作者信息

Colvin Lyn, Gill Andrew W, Slack-Smith Linda, Stanley Fiona J, Bower Carol

机构信息

Telethon Institute for Child Health Research, Centre for Child Health Research, The University of Western Australia, 100 Roberts Road, Subiaco, WA 6008, Australia.

Centre for Neonatal Research and Education, The University of Western Australia, 374 Bagot Road, Subiaco, WA 6008, Australia.

出版信息

Biomed Res Int. 2013;2013:909860. doi: 10.1155/2013/909860. Epub 2013 Dec 12.

DOI:10.1155/2013/909860
PMID:24396830
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3874333/
Abstract

AIMS

Nausea and vomiting of pregnancy is the most common medical condition in pregnancy. There is an increasing trend to prescribe ondansetron although its safety for use in pregnancy has not been established.

METHODS

Exposed pregnancies were all births in Western Australia, 2002-2005, where the mother was dispensed ondansetron under the Australian Pharmaceutical Benefits Scheme, compared with all other births during the same period. Outcomes investigated include maternal and child characteristics, birth defects, pregnancy, and delivery characteristics.

RESULTS

There were 96,968 births from 2002 to 2005. Ondansetron was dispensed to 251 pregnant women during this period. The women dispensed ondansetron were more likely to be privately insured (OR: 5.8; 95% CI: 4.3-7.9), to be Caucasian (3.3; 1.9-5.7), not to smoke during their pregnancy (2.9; 1.8-4.7), to have a multiple birth (2.7; 1.5-5.0), and to have used fertility treatment (1.8; 1.0-3.4). There was a small but not significantly increased risk of a major birth defect with first trimester exposure (1.2; 0.6-2.2).

CONCLUSIONS

Our study did not detect any adverse outcomes from the use of ondansetron in pregnancy but could not conclude that ondansetron is safe to use in pregnancy.

摘要

目的

妊娠恶心和呕吐是孕期最常见的病症。尽管昂丹司琼在孕期使用的安全性尚未确定,但开具该药物的趋势却在增加。

方法

将2002年至2005年在西澳大利亚州所有分娩且母亲根据澳大利亚药品福利计划配给了昂丹司琼的妊娠情况,与同期所有其他分娩情况进行比较。所调查的结果包括母婴特征、出生缺陷、妊娠和分娩特征。

结果

2002年至2005年共有96,968例分娩。在此期间,251名孕妇配给了昂丹司琼。配给昂丹司琼的女性更有可能拥有私人保险(比值比:5.8;95%置信区间:4.3 - 7.9)、为白种人(3.3;1.9 - 5.7)、孕期不吸烟(2.9;1.8 - 4.7)、多胎妊娠(2.7;1.5 - 5.0)以及接受过生育治疗(1.8;1.0 - 3.4)。孕早期接触昂丹司琼会有小幅度但无显著统计学意义的重大出生缺陷风险增加(1.2;0.6 - 2.2)。

结论

我们的研究未发现孕期使用昂丹司琼有任何不良后果,但无法得出昂丹司琼在孕期使用安全的结论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b13/3874333/6efa55987f79/BMRI2013-909860.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b13/3874333/6efa55987f79/BMRI2013-909860.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b13/3874333/6efa55987f79/BMRI2013-909860.001.jpg

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