摘要
妊娠期使用中药的有效性和安全性是学者关注的热点问题之一。然而,传统妊娠禁忌内容具有一定历史局限性,不能满足指导当前妊娠期合理使用中药的需要,亟需去粗取精和现代医学阐释。该文基于临床工作实际,借鉴西药妊娠期分级使用理念,从划分安全等级和拟定用药原则2个方面,梳理中药妊娠期使用安全性的古今认识,尝试进行妊娠期使用中药的安全性分级。文章分析了妊娠禁用、忌用和慎用本就具有的等级化内涵,结合若干妊娠食疗方展现出的部分中药较高的安全程度,划分药物安全性等级;同时,剖析了"有故无殒"、"衰其大半而止"理论的核心内容,并从现代生殖毒理、胚胎毒理和循证药学角度关注未知安全性风险,拟定合理用药基本原则。最后,明确提出妊娠期使用中药的安全性五等级(禁用、忌用、慎用、不确定、可用)的定义,分析界定了胚胎毒性中药(致畸、致突变、致发育不全等),传统毒性中药(堕胎、致流产等),峻烈性效表达中药(活血化瘀、破气消滞、辛温走窜等)和安全性较高药食两用中药的不同类别,并从客观实际出发设定"不确定"类别,合理划分了中药妊娠用药的安全等级;同时初步拟定了33味示例中药的类别归属。为中药妊娠期合理使用提供参考和思考。
The efficacy and safety of application of traditional Chinese medicines（ TCMs） during the pregnancy is a hotspot among scholars. However,the traditional pregnancy contraindication content has certain historical limitations,and cannot meet the needs of the current pregnant women for rational drug use. We need to refine and interpret it with modern medical science. In this paper,we summarized the ancient and modern knowledge about pregnancy contradiction and tried to establish a grading safety system,based on the actual clinical practices and thte medication grading concept of western medicines. Specifically speaking,in this paper,we compared the connotations of forbidden / contradiction and cautious use,and focused on the safe herbs that included in the prescriptions for dietary therapy. Meanwhile,in this paper,we summarized the core content of the famous theories of ″You Gu Wu Yun（ pregnancy disease） ″ and ″Shuai Qi Da Ban Er Zhi（ therapy during pregnancy） ″,and studied the dangerous and unknown risk of TCMs during pregnancy. At last,a five-grade safety system of TCMs applied on the pregnant women was established,including forbidden,contraindicated,cautious,uncertain and available medicines. We classified medicines with the embryotoxicity（ e. g. teratogenic,mutagenic,ageneisa）,the traditional toxicity（ e. g. abortion）,the fierce herbal property（ e. g. removing blood stasis,promoting Qi circulation） and reliable edible medicinal herbs. We also place an ″uncertain″ category based on objective reality. Meanwhile,33 sample TCMs were preliminarily determined. This paper proposed the preference and ideas for the rational herbal use in pregnancy.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2016年第1期150-153,共4页
China Journal of Chinese Materia Medica
基金
北京中医药大学基本科研业务费项目(2015-JYB-JSMS147)
北京药学会临床药学研究项目(2013-03)
关键词
中药
妊娠禁忌
安全性
分级
等级
孕妇
特殊人群
Chinese patent medicine
pregnancy contraindication
safety
classification
grading system
pregnant woman
special population
作者简介
王宇光，主管药师，主要从事中药临床合理用药研究，E—mail：wfwangyuguang@126．com
[通信作者]孔祥文，Tel：（010）52075316，E-mail：gongboran@sinz．com；
[通信作者]张冰，Tel：（010）64286335，E-mail：zhangbing6@263．net
