FDA对药物临床哺乳期研究的建议

目前由于哺乳期用药的人体数据极其缺乏，对哺乳期药物治疗以及是否继续母乳喂养往往难以做出准确决策。美国食品药品管理局（FDA）于2019年5月发布了“临床哺乳期研究：研究设计考虑的因素”指导原则（草案），对药物临床哺乳期研究的诸多方面提出了细致、具体的建议（如需要进行哺乳期研究的药物、研究类型、母乳取样方法、婴儿摄入母乳量的测量、药动学分析、婴儿剂量估算、婴儿安全数据的收集和药物对产乳量的影响等），以期促进该方面研究，获得所需信息。中国尚无类似的指导原则，详细介绍FDA该指导原则主要内容，希望对我国开展这方面的研究工作及其监管有益，也对结合国情制定类似的指导原则有所启示。

FDA's suggestion on clinical lactation study of drugs

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 Food and Drug Administration (FDA) issued the Clinical Lactation Studies: Considerations for Study Design Draft Guidance for Industry in May 2019.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.