哺乳期妇女应用中药安全问题分析与警戒

Safety of traditional Chinese medicine among lactating women and pharmacovigilance

目的分析哺乳期妇女应用中药发生药品不良反应(ADR)特点及原因,提出针对性的警戒防范措施。方法检索中国知网、万方数据、维普网及CBM数据库1964年1月1日至2020年8月31日哺乳期妇女应用中药致ADR的文献报道,对患者一般情况、ADR累及系统-器官、临床表现及转归等信息进行统计分析,应用SPSS软件对发生ADR的单味中药进行性、味、归经的关联性分析。结果纳入文献31篇、34例ADR案例,涉及19味单味中药、5种中成药、6种中药方剂。ADR主要累及胃肠系统、皮肤及其附件、中枢及外周神经系统;发生原因有患者个体差异等机体因素、毒性反应等药物因素及患者自行用药、临床辨证不当、调配错误、药物加工及煎煮不当等不合理用药因素。结论哺乳期应用中药发生安全问题多样,轻则乳母恶心呕吐,乳儿出现皮疹;重则乳母出血性休克、肾功能衰竭、永久性闭乳,乳儿血小板减少等。建议哺乳期应用中药应从治疗原则及药物选用等方面加强警戒,用药后密切监测,以助于哺乳期妇女临床安全合理应用中药。

Objective To analyze the characteristics and causes of adverse reactions(ADR)caused by traditional Chinese medicines(TCM)among lactating women,and propose targeted measures for pharmacovigilance and prevention.Methods Such databases as CNKI,Wanfang Data,VIP,CBM and PUBMED were searched to collect related literature that was published between January 1,1964 and August 31,2020 about the ADR caused by TCM among lactating women.The basic information about the patients,organs/systems involved in adverse reactions,clinical manifestations and Outcomes were statistically analyzed.The correlations between the four characters(FC),five tastes(FT)and channel distributions of the TCM involved in ADR were analyzed via SPSS 23.0.Results In this study,31 pieces of literature and 34 cases of ADR were included,involving 23 types of TCM,6 proprietary Chinese medicines and 5 compound medicines.The organs/systems involved were manifested in gastrointestinal damage,damage to the skin and its attachments,and damage to the central and peripheral nervous systems.The main causes of ADR included patients’individual differences,toxicity reactions,irrational drug use such as self-medication,improper clinical syndrome differentiation,misallocation,improper drug processing,and improper decoction.Conclusion TCM can cause varied safety problems during lactation,ranging from nausea and vomiting,through skin rash in babies,to hemorrhagic shock,renal failure,permanent breast closure in lactating women.It is recommended that pharmacovigilance should be strengthened in terms of treatment principles and drug selections for women during lactation.Furthermore,close monitoring is required after medication to promote the safety and rationality of TCM for lactating women.