文献类型：期刊文献

中文题名：中成药(含注射剂型)妊娠期用药安全性分级探索

英文题名：Safety grading of Chinese patent medicines(including injections)during pregnancy

作者：顾志荣[1,2];陈红宁[1];钱倩[1];瞿继兰[1];王雨[1];芦雅丽[1];萨日娜[1,2];张诗烨[3];黄清杰[4];李富云[5];葛斌[1];张冰[2,6];杨寿圆[7]

第一作者：顾志荣

机构：[1]甘肃省人民医院药剂科,甘肃兰州730000;[2]甘肃省人民医院岐黄学者张冰工作室,甘肃兰州730000;[3]甘肃中医药大学药学院,甘肃兰州730000;[4]甘肃省中医院药学部,甘肃兰州730050;[5]甘肃中医药大学附属医院药学部,甘肃兰州730099;[6]北京中医药大学中药学院,北京102488;[7]兰州市第一人民医院药剂科,甘肃兰州730050

第一机构：甘肃省人民医院药剂科,甘肃兰州730000

年份：2026

卷号：51

期号：4

起止页码：1197

中文期刊名：中国中药杂志

外文期刊名：China Journal of Chinese Materia Medica

收录：;北大核心:【北大核心2023】；

基金：国家卫生健康委员会国家药物政策研究项目(2025);甘肃省中医药管理局高水平重点项目(GZKZ-2024-16);甘肃省药品监督管理局药品监管科学研究项目(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);甘肃省人民医院省级科技创新平台项目(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)。

语种：中文

中文关键词：中药;中成药;妊娠毒性;安全性分级;合理用药

外文关键词：TCM;Chinese patent medicine;pregnancy toxicity;safety grading;rational drug use

摘要：目前我国尚无自主的妊娠期用药安全性分级,更无中成药(含注射剂型)妊娠期用药安全性分级及相关资料,使临床妊娠期中成药使用无据可依。该研究以古今中外妊娠期中药使用相关的文献报道为基础资料,包括古代本草与医学典籍记载,以及现代研究结果(包括动物实验、药物流行病学研究、临床试验、病例报道、药性研究等),以此形成证据集。以证据集为基础,结合中药药性特点及美国食品药品监督管理局(USFDA)妊娠期用药分级标准,建立了中成药(含注射剂型)妊娠期用药安全性ABCDX分级标准,并对临床常用的270余种中成药(含注射剂型)进行了分级,形成分级目录,给出用药建议。其中,A类中成药在妊娠期可按常用量使用,需遵医嘱;B类可在医师或药师监护下,按常用量慎用;C类只有在权衡对妊娠患者的益处大于对胎儿的危害时,或者无其他药物替代时方可谨慎使用;D类仅在孕妇用药后绝对受益,为挽救妊娠患者生命急需用药,而又无其他替代药物时方可考虑使用;X类禁止用于所有妊娠患者或可能受孕的患者。该分级作为国内相关研究的重要补充,可作为医师的用药参考及药师的药学服务工具,但也存在一定局限性,需根据最新出现的证据进行动态更新。
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.