不同来源的妊娠期用药危险性评估证据的比较

A comparative study of different references to the fetal risk of drugs in pregnancy

目的通过比较不同来源的妊娠期用药危险性评估证据,为妊娠期用药危险性评估提供科学参考。方法检索药物数据库Lexicomp、Micromedex,妊娠期和哺乳期用药专用数据库TERIS、Reprotox,并查找由Briggs、Schaefer分别主编的妊娠期和哺乳期用药专用书籍,搜集不同来源的妊娠期用药危险性评估证据。描述性分析不同来源资料对妊娠期用药介绍的体例、妊娠期用药风险评估的方法及妊娠期用药的具体内容。结果 6种来源资料对妊娠期用药介绍的体例稍有不同,但都包括药物胎盘透过情况、妊娠用药文献情况(人类研究和动物研究)和妊娠期使用总结。Micromedex、TERIS数据库和Briggs主编书籍分别采用简明的分级评估妊娠期药物使用风险。不同文献针对具体药物,不同资料的总结不尽相同,罗列证据的数量和内容亦有差别,尚无对证据的质量和相关性评价。结论妊娠期用药危险性评估尚无统一共识,危险性分级是目前临床快速判断妊娠期用药危险性的重要方法。现有资料仅对妊娠期用药研究进行了罗列,没有对其进行全面的质量和相关性评价,亟需妊娠期用药危险性评估的方法学研究。

Objective This study aims to compare different references for the fetal risk of drugs used in pregnancy to provide evidence for the safety of drug use in pregnancy. Methods Four drug databases, including Lexicomp, Micromedex, TERIS, and Reprotox, as well as two books of drugs in pregnancy edited by Briggs and Schaefer,were searched. Descriptive analysis was performed regarding the definition of pregnancy recommendations and the specific content of medication. Results The six references employed slightly different approaches to drugs in pregnancy,however, all of them included summaries of the risk in pregnancy, data of crossing the placenta, and human and animal data. The databases of Micromedex, TERIS, and a book edited by Briggs had their risk classification systems for drug use during pregnancy. For specific drugs, the summary of different information in pregnancy was different, the amount and content of listed evidence varied, and there was no evaluation of the quality and relevance of evidence among the references. Conclusions There is no consensus on the risk assessment of drugs in pregnancy. Risk classification systems for drugs in pregnancy are still an important method for determining the fetal risk of drugs. The existing references merely list studies of drugs in pregnancy, without comprehensive quality assessment. A methodological study of assessment of the risk of drugs in pregnancy is required.