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中华妇幼临床医学杂志(电子版)

Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition) ›› 2021, Vol. 17 ›› Issue (04): 393 -401. doi: 10.3877/cma.j.issn.1673-5250.2021.04.004

Standard·Proposal·Guideline

Technical specification for consultation on the risk of drug teratogenicity during pregnancy

Jing Tao1,1, Xiaohong Li1,2,1,2, Xi Tan3,3, Li Chen4,4, Aihua Yin5,5, He Wang6,6, Yangyu Zhao7,7, Yong Yang8,8, Xinwen Zhang9,9, Xiaohui Zhang10,10, Xueyan Wang11,11, Dunjin Chen12,12, Juan Du13,13, Suhua Chen14,14, Xiaoqing Jiang15,15, Guoying Zhang15,15, Li Li16,16, Yan Zhang17,17, Jinhua Gu18,18, Fen Li19,19, Lan Xie8,8, Juanjuan Zhao20,20, Chunhong Zhang21,21, Jun Zhu1,2,1,2,†()   

  • Received:2021-03-22 Revised:2021-07-19 Published:2021-08-01
  • Corresponding author: Jun Zhu
  • Supported by:
    National Key Research and Development Program of China(2018YFC1002201); Key Project of Research and Development of Science and Technology Department of Sichuan Province(2019YFS0530)
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Improper use of drugs by pregnant women during pregnancy may lead to fetal malformations. Counseling service on the risk of drug teratogenicity during pregnancy plays an important role in ensuring the safety of maternal and fetal medication and reducing birth defects. At present, some medical institutions in China have carried out counseling service on the risk of drug teratogenicity during pregnancy, but there is no relevant technical specification of the service. The Technical Specification for Consultation on the Risk of Drug Teratogenicity During Pregnancy has been jointly formulated by National Office for Maternal and Child Health Surveillance of China/National Center for Birth Defects Monitoring of China and multidisciplinary experts in department of obstetrics, pediatrics, pharmacy, etc. from Grade 3A medical institutions in China. The technical specification stipulates the definition, principle, process and service mode of drug teratogenic risk consultation service during pregnancy, in order to guide China′s medical institutions to standardize the counseling service, improve the service level, and ensure the safety of maternal and fetal medication.

Key words: Pregnancy, Drug toxicity, Abnormalities, drug-induced, Adverse drug reaction reporting systems, Directive counseling
图1 妊娠期药物致畸风险咨询服务流程图
表1 孕妇妊娠期用药对不同发育阶段胚胎/胎儿的影响
药物暴露时孕妇孕龄 药物对胎儿发育影响
受精后2周内(细胞增殖早期) 致畸因子的影响是"全"或"无"，即导致自然流产或对胚胎无影响
受精后3~8周(胚胎器官分化发育期) 致畸高敏感期，胚胎最易受到致畸因子影响而发生器官形态异常，但是各器官组织对不同致畸因子的反应各异
受精后第9周直至分娩(胚胎功能发育期) 胎儿生长、器官发育、功能完善形成期，胎儿外生殖器、骨骼系统、神经系统仍继续分化，致畸因子可能对这些结构和功能造成影响
图2 不同发育阶段胚胎/胎儿药物暴露与畸形发生关系示意图
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