产后及哺乳期妇女应用中药安全问题分析与用药警戒思考  

Chinese materia medica apply to lactation and postpartum women: Safety analysis and pharmacovigilance considerations

作　　者：汪文杰 林志健[1] 张冰[1] 李凡[1] 张晓朦[1] WANG Wen-jie;LIN Zhi-jian;ZHANG Bing;LI Fan;ZHANG Xiao-meng(School of Chinese Materia Medica, Beijing University of Chinese Medicine, Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing 100029, China)

机构地区：[1]北京中医药大学中药学院中药药物警戒与合理用药研究中心,北京100029

出　　处：《中华中医药杂志》2018年第7期2852-2855,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：北京市中医管理局项目(颜正华临床中药学教育体系的构建与推广);北京中医药大学新奥优秀传承团队建设项目(国医大师颜正华名医工作室优秀传承团队;颜正华临床中药学思想的挖掘与传承模式研究);北京中医药大学教育科学研究课题(No.XJY15002)~~

摘　　要：目的:通过对产后及哺乳期妇女应用中药导致安全问题的事件报道的系统梳理,分析其发生不良反应/事件(ADR/ADE)的特点及原因,提出药物警戒与合理用药建议。方法:系统检索国内外文献报道,收集和整理该时期妇女应用中药的ADR/ADE报道文献,采用回顾性研究和统计学方法对该时期妇女应用中药的不良反应情况进行分析。结果:检索在产后及哺乳期妇女使用中药发生不良反应的报道,最终纳入到ADR/ADE文献报道14篇,病例14例,涉及ADR/ADE的中药饮片11味,中成药为3种,损害人体多个器官及系统。分析可知,导致发生ADR/ADE的主要原因有个体差异、误用滥用、毒性药物使用不当等。结论:在产后及哺乳期使用中药导致安全事件的原因多样,文章提出在此类特殊人群中使用中药的警戒措施,为临床的安全合理应用提供参考和指导。Objective： To analyze the characteristics and reasons of adverse drug reactions/adverse drug events（ADR/ADE）, and provide suggestions for the pharmacovigilance and the rational use of prepared slices of Chinese materia medica and Chinese patent medicine for postpartum and lactating women. Methods： Reviewed the literature reports Chinese Materia Medica for postpartum and lactating women from Jan 1980 to Jan 2017 and then analyzed the characteristics and reasons of ADR/ADE by retrospective study and statistical methods. Results： 14 literature reports of ADR/ADE were selected, in which 11 kinds of herbs and 3 kinds of Chinese patent medicine were involved. The above ADR/ADE cases affected multiple organs and systems. The main influence factors were individual differences, misuse and abuse, improper compatibility, and so on. Conclusion： The reasons of security incidents for Chinese materia medica for postpartum and lactating women is complicated. Therefore, it is necessary to put forward corresponding pharmacovigilance, and offer reference and guidance for the safe and rational clinical application.

关 键 词：哺乳期 产后 中药 不良反应 用药警戒 

分 类 号：R271[医药卫生—中医妇科学]