目前由于哺乳期用藥的人體數(shù)據(jù)極其缺乏，對哺乳期藥物治療以及是否繼續(xù)母乳喂養(yǎng)往往難以做出準(zhǔn)確決策。美國食品藥品管理局（FDA）于2019年5月發(fā)布了“臨床哺乳期研究：研究設(shè)計考慮的因素”指導(dǎo)原則（草案），對藥物臨床哺乳期研究的諸多方面提出了細(xì)致、具體的建議（如需要進行哺乳期研究的藥物、研究類型、母乳取樣方法、嬰兒攝入母乳量的測量、藥動學(xué)分析、嬰兒劑量估算、嬰兒安全數(shù)據(jù)的收集和藥物對產(chǎn)乳量的影響等），以期促進該方面研究，獲得所需信息。中國尚無類似的指導(dǎo)原則，詳細(xì)介紹FDA該指導(dǎo)原則主要內(nèi)容，希望對我國開展這方面的研究工作及其監(jiān)管有益，也對結(jié)合國情制定類似的指導(dǎo)原則有所啟示。

At present, due to the extremely lack of human data on medication during lactation, it is difficult to make accurate decisions on medication during lactation and breastfeeding. Food and Drug Administration (FDA) issued the Clinical Lactation Studies: Considerations for Study Design Draft Guidance for Industry in May 2019. Detailed and specific suggestions on many aspects of drug clinical lactation research were put forward, such as drugs needed for lactation research, research types, breast milk sampling methods, measurement of infant breast milk intake, pharmacokinetic analysis, infant dose estimation, infant safety data collection and effects of drug on milk production, so as to promote the research in this field, and obtain the required information. However, there is no similar guidance in China. This paper introduces the FDA's guidance in detail. It is hoped that it will be helpful for China to carry out the research and supervision in this field, and also enlighten us to formulate similar guidance principles according to the national conditions.