Weber-Schoendorfer Corinna, Schaefer Christof
Pharmakovigilanz- und Beratungszentrum Embryonaltoxikologie Berlin, Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Spandauer Damm 130, Haus 10, 14050 Berlin, Germany.
Reprod Toxicol. 2008 Sep;26(1):19-23. doi: 10.1016/j.reprotox.2008.05.053. Epub 2008 May 13.
To assess the safety of cetirizine during pregnancy.
A prospective observational cohort study with data of the Berlin teratology information center from 1992 until 2006. Pregnancy outcome was compared between a cohort of pregnant women exposed to cetirizine during the first trimester (n=196) and a control group not exposed to potential teratogens (n=1686).
Major birth defects were not more common in the study group than in the control group (OR 1.07; CI 0.21-3.59). We also compared the crude rate of spontaneous abortions (OR 0.97; CI 0.54-1.65), of preterm deliveries (OR 0.76; CI 0.35-1.5), and the birth weight of term newborns (p=0.13).
This prospective observational study on cetirizine in pregnancy suggests that the use of cetirizine is relatively safe during the first trimester.
评估孕期使用西替利嗪的安全性。
一项前瞻性观察队列研究，采用了柏林畸形学信息中心1992年至2006年的数据。比较了孕早期暴露于西替利嗪的孕妇队列（n = 196）和未暴露于潜在致畸剂的对照组（n = 1686）的妊娠结局。
研究组的严重出生缺陷并不比对照组更常见（比值比1.07；可信区间0.21 - 3.59）。我们还比较了自然流产的粗发生率（比值比0.97；可信区间0.54 - 1.65）、早产的粗发生率（比值比0.76；可信区间0.35 - 1.5）以及足月儿的出生体重（p = 0.13）。
这项关于孕期使用西替利嗪的前瞻性观察研究表明，孕早期使用西替利嗪相对安全。
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