193例苍耳子不良反应文献分析  

Literature Analysis of 193 Cases of Adverse Reactions of Xanthii Fructus

作　　者：杨雪[1] 夏东胜[2] 高建超[2] 田春华[2] 李岚[2] 张冰[1] 

机构地区：[1]北京中医药大学,北京100029 [2]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2016年第11期691-696,共6页Chinese Journal of Pharmacovigilance

基　　金：中医药行业科研专项(201507004)

摘　　要：目的探讨苍耳子临床毒性特点及安全风险因素,为其安全使用提供文献依据。方法检索1953年1月—2016年4月苍耳子不良反应相关文献,建立数据库并进行分项统计与分析,提取苍耳子毒性特点及安全性影响因素。结果苍耳子口服及外用均可致不良反应。口服苍耳子所致不良反应可涉及多脏器损伤,以消化系统损害为多,且以肝损害最为多见;外用苍耳子所致不良反应以皮肤及其附件损害为主,以接触性皮炎多见。苍耳子不良反应/事件的主要风险因素有:儿童误服/误吸入、未经炮制或炮制不当、超剂量用药或用药时间长、自行使用或偏方用药及患者体质因素等。结论应重视苍耳子毒性,控制其风险因素,严防误用并有效防止不良反应/事件的发生。Objective To explore the clinical toxicity characteristics and risk factor, in order to offer literature basis for clinicalsafety medication. Methods The adverse reactions of Xanthii Fructus on literatures between January 1st, 1953 April 1st, 2016were summarized, the toxicity characteristics and risk factors for clinical use were analyzed. Results Oral and external use ofXanthii Fructus can lead to adverse reactions. Oral use of Xanthii Fructus caused multiple organ damage, the main damages aredigestive damage and liver damage. External use of Xanthii Fructus caused skin lesions, the main damage was contact dermatitis.The main risk factors of adverse reactions/events of Xanthii Fructus were misuse in children, inappropriate drug processing,overdosage, using out of the direction of doctor, using folk prescription and patients, physique. Conclusion Toxicity of XanthiiFructus should be paid attention in the clinical use, so as to control the risk factors and prevent the happening of adverse drugreactions.

关 键 词：苍耳子 不良反应 文献分析 

分 类 号：R994.11[医药卫生—毒理学]