Use of prescription medications with a potential for fetal harm among pregnant women
Use of prescription medications with a potential for fetal harm among pregnant women
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DOI：
10.1002/pds.1235
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发表时间：
2006-08-01
影响因子：
2.6
通讯作者：
Gurwitz, Jerry H.
中科院分区：
文献类型：
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作者：
Andrade, Susan E.;Raebel, Marsha A.;Gurwitz, Jerry H.
目的估计使用处方药的患病率与潜在的胎儿伤害孕妇在UnitedStates.Methods进行了回顾性研究，使用自动化数据库的8个健康维护组织参与HMO研究网络中心的教育和治疗研究（CERT）。查明了1996年1月至2000年12月期间分娩婴儿的妇女。使用可能对胎儿造成伤害的处方药的频率是基于临床畸形学家的专家审查和美国食品药品监督管理局（FDA）的风险分类系统，结果在114 165例无诊断文件提示潜在产前诊断的妇女中，足月分娩或在分娩前270天内分发促排卵药，根据临床畸形学家的专家审查，1305名（1.1%）在分娩前270天内接受了致畸药物。接受美国FDA D类或X类药物的女性比例更大（5.8%; N = 6600）。然而，一般使用模式相似，与妊娠后期相比，妊娠早期使用率较高。在怀孕前90天内接受致畸剂的妇女在怀孕期间分发致畸剂的比例明显高于未接受致畸剂的妇女（调整后的RR = 38.9，95%CI，33.5，45.3）结论我们的研究结果表明，进一步努力指导医生咨询妇女或妇女本身关于特定药物的潜在风险，有正当理由版权所有（c）2006约翰威利父子有限公司。
Purpose To estimate the prevalence of use of prescription drugs with a potential for fetal harm among pregnant women in the United States.Methods A retrospective study was conducted using the automated databases of eight health maintenance organizations involved in the HMO Research Network Center for Education and Research on Therapeutics (CERT). Women who delivered an infant from January 1996 to December 2000 were identified. The frequency of use of prescription drugs with a potential for fetal harm was based upon the expert review of a clinical teratologist and the U.S. Food and Drug Administration (FDA) risk classification system, assuming a gestational duration of 270 days.Results Among the 114 165 women with no documentation of a diagnosis suggesting potential pre-term birth or dispensing of ovulation stimulants in the 270 days before delivery, 1305 (1.1 %) received a teratogenic drug during the 270 days before delivery, based upon the expert review of a clinical teratologist. A larger proportion of women received U.S. FDA category D or X drugs (5.8%; N = 6600). However, the general patterns of use were similar, with higher use in early pregnancy compared to later trimesters. The proportion of women dispensed a teratogen during pregnancy was substantially higher among women who received a teratogen in the 90 days before pregnancy compared to women who did not (adjusted RR = 38.9, 95%CI, 33.5, 45.3).Conclusions Our results suggest that further efforts directed at physicians to counsel women or at the women themselves about the potential risks of particular medications appear warranted. Copyright (c) 2006 John Wiley & Sons, Ltd.