Use of omeprazole during pregnancy -: no hazard demonstrated in 955 infants exposed during pregnancy

Use of omeprazole during pregnancy -: no hazard demonstrated in 955 infants exposed during pregnancy
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DOI:
10.1016/s0301-2115(00)00388-2
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发表时间:
2001-05-01
期刊:
EUROPEAN JOURNAL OF OBSTETRICS GYNECOLOGY AND REPRODUCTIVE BIOLOGY
影响因子:
--
通讯作者:
Källén, BAJ
Källén, BAJ
中科院分区:
其他
文献类型:
--
作者:
Källén, BAJ

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目的:评价妊娠期间母亲使用奥美拉唑可能涉及的胎儿风险程度。研究设计:母亲在妊娠期间使用奥美拉唑的婴儿从瑞典医学出生登记处确定。1995-1999年期间出生的婴儿中共有955名婴儿被确定为接触过此种物质:其中863名婴儿在怀孕早期接触过此种物质,131名婴儿在怀孕后期接触过此种物质,39名婴儿在怀孕早期和怀孕后期都接触过此种物质。研究分娩结局:存在先天性畸形。到1997年底,围产期存活率、出生体重低、阿普加评分低和住院治疗。结果:没有明显的不良反应迹象。五名婴儿死产,先天性心脏缺陷的发生率略有增加,但这两种影响可能是随机的。结论:目前的数据集和先前发表的数据没有理由担心妊娠期间暴露于奥美拉唑后的问题。(C)2001爱思唯尔科学爱尔兰有限公司保留所有权利。
Objectives: To evaluate the magnitude of possible fetal risks involved in maternal use of omeprazole during pregnancy. Study design: Infants whose mothers used omeprazole during pregnancy were identified from the Swedish Medical Birth Registry. A total of 955 exposed infants born in 1995-1999 were identified: 863 of which were exposed in early pregnancy and 131 later in pregnancy and 39 who had been exposed both in early and late pregnancy. Delivery outcome was studied: presence of congenital malformations. perinatal survival, low birth weight, low Apgar score and hospitalization up to the end of 1997. Results: No clear-cut indication of ill effects were seen. Five infants were stillborn and the rate of congenital heart defects was slightly increased, but both effects may be random. Conclusions: The present dataset and previously published data give no reason for concern after exposure for omeprazole during pregnancy. (C) 2001 Elsevier science Ireland Ltd. All rights reserved.