Pregnancy outcomes following systemic prenatal acyclovir exposure: Conclusions from the International Acyclovir Pregnancy Registry, 1984-1999

Pregnancy outcomes following systemic prenatal acyclovir exposure: Conclusions from the International Acyclovir Pregnancy Registry, 1984-1999
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DOI:
10.1002/bdra.20013
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发表时间:
2004-04-01
影响因子:
--
通讯作者:
Andrews, EB
Andrews, EB
中科院分区:
医学4区
文献类型:
--
作者:
Stone, KM;Reiff-Eldridge, R;Andrews, EB

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生殖器疱疹是由生殖器疱疹病毒引起的。关于潜在胎儿风险的数据非常有限。从1984年到1998年,妊娠登记处监测了妊娠期间口服或静脉注射阿昔洛韦的妇女的出生结果。本报告描述了最终结果。方法:登记处向最有可能诊断怀孕的卫生保健提供者公布;提供者拨打登记处的电话号码,然后邮寄一份简短的调查问卷。妊娠结局分为有出生缺陷的结局或无出生缺陷的结局,再分为活产、自然流产(包括死产)和人工流产。出生缺陷的定义是使用CDC对出生缺陷监测系统定义的修改。将观察到的出生缺陷率与一般人群中预期的出生缺陷率(3.2%)进行比较。结果:在1984年6月1日至1998年6月30日期间,登记了1695例口服或静脉注射阿昔洛韦的孕妇; 461例(27%)失访。在24个国家的1234例妊娠中,共有1246例妊娠结局。在1246例妊娠结局中,756例妊娠早期暴露于阿昔洛韦,197例妊娠中期暴露于阿昔洛韦,291例妊娠晚期暴露于阿昔洛韦。在妊娠早期暴露于阿昔洛韦的活产婴儿中,出生缺陷的风险为19/596(3.2%; 95%CI,2.0-5.0%)。没有明显的异常缺陷或缺陷模式。结论:观察到的出生缺陷的孕妇接触阿昔洛韦的比率和类型没有显着差异,从那些在一般人群。2004年出版Wiley-Liss,Inc.
Oral acyclovir is commonly used for genital herpes and other herpesvirus infections. Data on potential fetal risk are extremely limited. From 1984 to 1998, the Acyclovir in Pregnancy Registry monitored birth outcomes of women exposed to oral or intravenous acyclovir during pregnancy. This report describes the final results. METHODS: The registry was publicized to health care providers most likely to diagnose pregnancy; providers called the registry telephone number, then mailed in a brief questionnaire. Pregnancy outcomes were categorized either as outcomes with birth defects or outcomes without birth defects, subcategorized as live births, spontaneous pregnancy losses (including stillbirths), and induced abortions. Birth defects were defined using a modification of the CDC definition for birth defects surveillance systems. Observed rates were compared to the rate (3.2%) of birth defects expected in the general population. RESULTS: Between June 1, 1984 and June 30, 1998, 1695 pregnancies exposed to oral or IV acyclovir were registered; 461 (27%) were lost to follow-up. A total of 1234 pregnancies in 24 countries were followed, with a total of 1246 outcomes. Among 1246 pregnancy outcomes, 756 involved acyclovir exposure in the first trimester, 197 in the second trimester, and 291 in the third trimester. Among live births with first trimester acyclovir exposure, risk of birth defects was 19 of 596 (3.2%; 95% Cl, 2.0-5.0%). No unusual defects or pattern of defects were apparent. CONCLUSIONS: The observed rates and types of birth defects for pregnancies exposed to acyclovir did not differ significantly from those in the general population. Published 2004 Wiley-Liss, Inc.