妊娠期药物致畸风险咨询技术规范

doi:10.3877/cma.j.issn.1673-5250.2021.04.004

中华妇幼临床医学杂志(电子版) ›› 2021, Vol. 17 ›› Issue (04) : 393 -401. doi: 10.3877/cma.j.issn.1673-5250.2021.04.004

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妊娠期药物致畸风险咨询技术规范

陶晶¹^,¹, 李小洪¹^,²^,¹^,², 谭曦³^,³, 陈力⁴^,⁴, 尹爱华⁵^,⁵, 王和⁶^,⁶, 赵扬玉⁷^,⁷, 杨勇⁸^,⁸, 张欣文⁹^,⁹, 张晓辉¹⁰^,¹⁰, 王雪燕¹¹^,¹¹, 陈敦金¹²^,¹², 杜娟¹³^,¹³, 陈素华¹⁴^,¹⁴, 蒋小青¹⁵^,¹⁵, 张国英¹⁵^,¹⁵, 李力¹⁶^,¹⁶, 张岩¹⁷^,¹⁷, 顾锦华¹⁸^,¹⁸, 李芬¹⁹^,¹⁹, 谢兰⁸^,⁸, 赵娟娟²⁰^,²⁰, 张春红²¹^,²¹, 朱军¹^,²^,^†^,¹^,²(

)

收稿日期:2021-03-22 修回日期:2021-07-19 出版日期:2021-08-01
通信作者: 朱军

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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陶晶, 李小洪, 谭曦, 陈力, 尹爱华, 王和, 赵扬玉, 杨勇, 张欣文, 张晓辉, 王雪燕, 陈敦金, 杜娟, 陈素华, 蒋小青, 张国英, 李力, 张岩, 顾锦华, 李芬, 谢兰, 赵娟娟, 张春红, 朱军. 妊娠期药物致畸风险咨询技术规范[J]. 中华妇幼临床医学杂志(电子版), 2021, 17(04): 393-401.

Jing Tao, Xiaohong Li, Xi Tan, Li Chen, Aihua Yin, He Wang, Yangyu Zhao, Yong Yang, Xinwen Zhang, Xiaohui Zhang, Xueyan Wang, Dunjin Chen, Juan Du, Suhua Chen, Xiaoqing Jiang, Guoying Zhang, Li Li, Yan Zhang, Jinhua Gu, Fen Li, Lan Xie, Juanjuan Zhao, Chunhong Zhang, Jun Zhu. Technical specification for consultation on the risk of drug teratogenicity during pregnancy[J]. Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition), 2021, 17(04): 393-401.

孕妇妊娠期用药不当可能具有导致胎儿发生畸形的风险。妊娠期药物致畸风险咨询服务在保障母胎用药安全、减少出生缺陷方面发挥重要作用。目前，我国部分医疗机构已开展妊娠期药物致畸风险咨询服务，但是尚未制定涉及该项服务的相关技术规范。四川大学华西第二医院全国妇幼卫生监测办公室/中国出生缺陷监测中心，联合国内多家三级甲等医疗机构的产科、儿科、药剂科等多学科专家，共同制定《妊娠期药物致畸风险咨询技术规范》。该技术规范规定了妊娠期药物致畸风险咨询服务的定义、原则、流程、服务方式等内容，旨在指导我国医疗机构规范开展该项咨询服务工作，提升服务水平，保障母胎用药安全。

关键词: 妊娠, 药物毒性, 畸形，药物性, 药物副反应报告系统, 指示性咨询

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

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

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