中国中药杂志2026，Vol.51Issue(4)：1197-1216,20.DOI:10.19540/j.cnki.cjcmm.20251210.501
中成药(含注射剂型)妊娠期用药安全性分级探索
Safety grading of Chinese patent medicines(including injections)during pregnancy
摘要
Abstract
At present,China has no autonomous safety classification for medication use during pregnancy,and there is even no safety classification or related information for Chinese patent medicines(including injections)used during pregnancy,leaving clinical use of Chinese patent medicines in pregnant patients without evidence-based guidance.This study used literature reports on the use of TCM during pregnancy from ancient to modern times,both in China and abroad,as basic source materials.These included records from ancient herbal and medical classics as well as modern research results(including animal experiments,pharmacoepidemiological studies,clinical trials,case reports,and studies on medicinal properties),thereby forming an evidence set.Based on this evidence set,and taking into account the characteristics of TCM along with the pregnancy medication grading standards of the USFDA,an ABCDX safety grading standard for the use of Chinese patent medicines(including injections)during pregnancy was established.More than 270 commonly used Chinese patent medicines(including injections)were graded,producing a grading catalogue along with medication recommendations.Among these,class A Chinese patent medicines may be used during pregnancy at the usual dosage,but medical advice must still be followed.Class B Chinese patent medicines may be used with caution at the usual dosage under the supervision of a physician or pharmacist.Class C Chinese patent medicines may be used cautiously only when the benefits to the pregnant patient outweigh the risks to the fetus,or when no alternative medication is available.Class D Chinese patent medicines may be considered only when the pregnant patient will definitely benefit from their use,when the medication is urgently needed to save the patient's life,and when no alternative drugs exist.Class X Chinese patent medicines are prohibited for all pregnant patients or patients who may become pregnant.This grading system serves as a valuable supplement to relevant domestic research and can serve as a prescribing reference for physicians and a pharmaceutical service tool for pharmacists.However,it also has certain limitations and needs to be dynamically updated in accordance with newly emerging evidence.关键词
中药/中成药/妊娠毒性/安全性分级/合理用药Key words
TCM/Chinese patent medicine/pregnancy toxicity/safety grading/rational drug use引用本文复制引用
顾志荣,李富云,葛斌,张冰,杨寿圆,陈红宁,钱倩,瞿继兰,王雨,芦雅丽,萨日娜,张诗烨,黄清杰..中成药(含注射剂型)妊娠期用药安全性分级探索[J].中国中药杂志,2026,51(4):1197-1216,20.基金项目
国家卫生健康委员会国家药物政策研究项目(2025) （2025）
甘肃省中医药管理局高水平重点项目(GZKZ-2024-16) （GZKZ-2024-16）
甘肃省药品监督管理局药品监管科学研究项目(2023GSMPA046) （2023GSMPA046）
甘肃省人民医院中西医结合优势病种科技专项项目(23GSSYE-7) （23GSSYE-7）
甘肃省人民医院省级科技创新平台项目(23GSSYB-16) （23GSSYB-16）
中国健康促进基金会"公立医院高质量发展科研公益项目"(2024) （2024）
