妊娠期药物致畸风险咨询技术规范  

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

作　　者：陶晶 李小洪 谭曦 陈力[4] 尹爱华[5] 王和[6] 赵扬玉[7] 杨勇[8] 张欣文 张晓辉[10] 王雪燕[11] 陈敦金[12] 杜娟[13] 陈素华 蒋小青[15] 张国英 李力 张岩[17] 顾锦华[18] 李芬[19] 谢兰[8] 赵娟娟 张春红[21] 朱军 Tao Jing;Li Xiaohong;Tan Xi;Chen Li;Yin Aihua;Wang He;Zhao Yangyu;Yang Yong;Zhang Xinwen;Zhang Xiaohui;Wang Xueyan;Chen Dunjin;Du Juan;Chen Suhua;Jiang Xiaoqing;Zhang Guoying;Li Li;Zhang Yan;Gu Jinhua;Li Fen;Xie Lan;Zhao Juanjuan;Zhang Chunhong;Zhu Jun(National Office for Maternal and Child Health Surveillance of China/National Center for Birth Defects Monitoring of China,West China Second University Hospital,Sichuan University,Chengdu 610041,Sichuan Province,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children(Sichuan University),Ministry of Education,West China Second University Hospital,Sichuan University,Chengdu 610041,Sichuan Province,China;Department of Obstetrics and Gynecology,West China Second University Hospital,Sichuan University,Chengdu 610041,Sichuan Province,China;Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041,Sichuan Province,China;Guangdong Maternal and Child Health Hospital,Guangzhou 510010,Guangdong Province,China;Prenatal Diagnostic Center,West China Second University Hospital,Sichuan University,Chengdu 610041,Sichuan Province,China;Peking University Third Hospital,Beijing 100191,China;Sichuan Academy of Medical Sciences·Sichuan Provincial People′s Hospital,Chengdu 610072,Sichuan Province,China;Xi′an People′s Hospital/Xi′an Fourth Hospital,Xi′an 710061,Shaanxi Province,China;Women′s Hospital School of Medicine Zhejiang University,Hangzhou 310006,Zhejiang Province,China;Chongqing Health Center for Women and Children,Chongqing 400010,China;Third Affiliated Hospital of Guangzhou Medical University,Guangzhou 510150,Guangdong Province,China;Maternal and Child Health Care Hospital of Guangxi Zhuang Autonomous Region,Nanning 530003,Guangxi Zhuang Autonomous Region,China;Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430030,Hubei Province,China;Jiangsu Women and Children Health Hospital,Nanjing 210036,Jiangsu Province,China;Army Medical Center for People�

机构地区：[1]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,成都610041 [2]四川大学华西第二医院出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [3]四川大学华西第二医院妇产科,成都610041 [4]四川大学华西第二医院药剂科,成都610041 [5]广东省妇幼保健院,广州510010 [6]四川大学华西第二医院产前诊断中心,成都610041 [7]北京大学第三医院,100191 [8]四川省医学科学院·四川省人民医院,成都610072 [9]西安市人民医院/西安市第四医院,710004 [10]浙江大学医学院附属妇产科医院,杭州310006 [11]重庆市妇幼保健院,400010 [12]广州医科大学附属第三医院,510150 [13]广西壮族自治区妇幼保健院,南宁530003 [14]华中科技大学同济医学院附属同济医院,武汉430030 [15]江苏省妇幼保健院,南京210036 [16]陆军特色医学中心,重庆400042 [17]无锡市妇幼保健院,214000 [18]南通大学附属妇幼保健院,226000 [19]西安交通大学第一附属医院,710061 [20]新疆乌鲁木齐市妇幼保健院,830000 [21]温州医科大学附属第一医院,325000

出　　处：《中华妇幼临床医学杂志（电子版）》2021年第4期393-401,共9页Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition)

基　　金：国家重点研发计划专项项目(2018YFC1002201);四川省科技计划重点研发项目(2019YFS0530)。

摘　　要：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。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.

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 

分 类 号：R71[医药卫生—妇产科学]