妊娠期应用昂丹司琼与不良胎儿结局风险。
Ondansetron in pregnancy and risk of adverse fetal outcomes.
机构信息
Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.
出版信息
N Engl J Med. 2013 Feb 28;368(9):814-23. doi: 10.1056/NEJMoa1211035.
BACKGROUND
Ondansetron is frequently used to treat nausea and vomiting during pregnancy, but the safety of this drug for the fetus has not been well studied.
METHODS
We investigated the risk of adverse fetal outcomes associated with ondansetron administered during pregnancy. From a historical cohort of 608,385 pregnancies in Denmark, women who were exposed to ondansetron and those who were not exposed were included, in a 1:4 ratio, in propensity-score-matched analyses of spontaneous abortion (1849 exposed women vs. 7396 unexposed women), stillbirth (1915 vs. 7660), any major birth defect (1233 vs. 4932), preterm delivery (1792 vs. 7168), and birth of infants at low birth weight and small for gestational age (1784 vs. 7136). In addition, estimates were adjusted for hospitalization for nausea and vomiting during pregnancy (as a proxy for severity) and the use of other antiemetics.
RESULTS
Receipt of ondansetron was not associated with a significantly increased risk of spontaneous abortion, which occurred in 1.1% of exposed women and 3.7% of unexposed women during gestational weeks 7 to 12 (hazard ratio, 0.49; 95% confidence interval [CI], 0.27 to 0.91) and in 1.0% and 2.1%, respectively, during weeks 13 to 22 (hazard ratio, 0.60; 95% CI, 0.29 to 1.21). Ondansetron also conferred no significantly increased risk of stillbirth (0.3% for exposed women and 0.4% for unexposed women; hazard ratio, 0.42; 95% CI, 0.10 to 1.73), any major birth defect (2.9% and 2.9%, respectively; prevalence odds ratio, 1.12; 95% CI, 0.69 to 1.82), preterm delivery (6.2% and 5.2%; prevalence odds ratio, 0.90; 95% CI, 0.66 to 1.25), delivery of a low-birth-weight infant (4.1% and 3.7%; prevalence odds ratio, 0.76; 95% CI, 0.51 to 1.13), or delivery of a small-for-gestational-age infant (10.4% and 9.2%; prevalence odds ratio, 1.13; 95% CI, 0.89 to 1.44).
CONCLUSIONS
Ondansetron taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes. (Funded by the Danish Medical Research Council.).
背景
昂丹司琼常用于治疗妊娠期间的恶心和呕吐，但该药对胎儿的安全性尚未得到充分研究。
方法
我们研究了与妊娠期间使用昂丹司琼相关的不良胎儿结局风险。在丹麦的一项历史队列中，纳入了 608385 例妊娠的女性，按照 1：4 的比例，对接受昂丹司琼和未接受昂丹司琼的女性进行了药物暴露史与自发性流产（1849 例暴露女性与 7396 例未暴露女性）、死胎（1915 例与 7660 例）、任何重大出生缺陷（1233 例与 4932 例）、早产（1792 例与 7168 例）以及低出生体重和小于胎龄儿的分娩（1784 例与 7136 例）的倾向评分匹配分析。此外，还对因妊娠恶心和呕吐住院（作为严重程度的替代指标）以及使用其他止吐药进行了调整。
结果
在妊娠第 7 至 12 周（风险比，0.49；95%置信区间[CI]，0.27 至 0.91）和妊娠第 13 至 22 周（风险比，0.60；95%CI，0.29 至 1.21），接受昂丹司琼与自发性流产的风险显著增加无关，分别在暴露女性中发生 1.1%，在未暴露女性中发生 3.7%；分别在暴露女性和未暴露女性中发生 0.3%和 0.4%，风险比为 0.42；95%CI，0.10 至 1.73）。昂丹司琼也与死胎风险无显著增加相关（暴露女性中发生 0.3%，未暴露女性中发生 0.4%；风险比，0.42；95%CI，0.10 至 1.73）、任何重大出生缺陷（暴露女性中发生 2.9%，未暴露女性中发生 2.9%；患病比值比，1.12；95%CI，0.69 至 1.82）、早产（暴露女性中发生 6.2%，未暴露女性中发生 5.2%；患病比值比，0.90；95%CI，0.66 至 1.25）、低出生体重儿（暴露女性中发生 4.1%，未暴露女性中发生 3.7%；患病比值比，0.76；95%CI，0.51 至 1.13）或小于胎龄儿（暴露女性中发生 10.4%，未暴露女性中发生 9.2%；患病比值比，1.13；95%CI，0.89 至 1.44）。
结论
在妊娠期间使用昂丹司琼与不良胎儿结局风险的显著增加无关。（由丹麦医学研究委员会资助）。
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