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安全药物妊娠清单:基于网络信息的证据基础不足和指导意见不一致,2011 年。

Safe lists for medications in pregnancy: inadequate evidence base and inconsistent guidance from Web-based information, 2011.

机构信息

Rollins School of Public Health, Emory University, Atlanta, GA, USA.

出版信息

Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):324-8. doi: 10.1002/pds.3410. Epub 2013 Jan 29.

Abstract

PURPOSE

Medication use during pregnancy is common and increasing. Women are also increasingly getting healthcare information from sources other than their physicians.

METHODS

This report summarizes an environmental scan that identified 25 active Internet sites that list medications reported to be safe for use in pregnancy and highlights the inadequate evidence base and inconsistent guidance provided by these sites.

RESULTS

These lists included 245 different products, of which 103 unique components had been previously evaluated in terms of fetal risk by the Teratogen Information System (TERIS), a resource that assesses risk of birth defects after exposure under usual conditions by consensus of clinical teratology experts. For 43 (42%) of the 103 components that were listed as 'safe' on one or more of the Internet sites surveyed, the TERIS experts were unable to determine the fetal risk based on published scientific literature. For 40 (93%) of these 43, either no data were available to assess human fetal risk or the available data were limited.

CONCLUSIONS

Women who see a medication on one of these 'safe' lists would be led to believe that there is no increased risk of birth defects resulting from exposure. Thus, women are being reassured that fetal exposure to these medications is safe even though a sufficient evidence base to determine the relative safety or risk does not exist.

摘要

目的

孕期用药较为常见且呈上升趋势。此外,越来越多的女性开始从医生以外的其他渠道获取医疗保健信息。

方法

本报告总结了一项环境扫描,该扫描确定了 25 个活跃的互联网网站,这些网站列出了据报道在妊娠期间使用安全的药物,并强调了这些网站提供的证据基础不足和指导意见不一致的问题。

结果

这些清单包括 245 种不同的产品,其中 103 种独特的成分之前已经通过致畸信息系统(TERIS)进行了胎儿风险评估,TERIS 是一个通过临床致畸学专家的共识来评估在常规条件下暴露于致畸原后出现出生缺陷风险的资源。在所调查的 103 种成分中,有 43 种(42%)在一个或多个互联网网站上被列为“安全”,TERIS 专家无法根据已发表的科学文献确定胎儿风险。对于这 43 种中的 40 种(93%),要么没有可用数据来评估人类胎儿风险,要么可用数据有限。

结论

看到这些“安全”清单上的一种药物,女性可能会认为接触这些药物不会增加胎儿出现出生缺陷的风险。因此,尽管不存在确定相对安全性或风险的充分证据基础,但女性会被告知胎儿接触这些药物是安全的。

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