中国药物警戒 ›› 2016, Vol. 13 ›› Issue (11): 691-696.

• 安全性评价与合理用药 • 上一篇    下一篇

193例苍耳子不良反应文献分析

杨雪1, 夏东胜2*, *, 高建超2, 田春华2, 李岚2, 张冰1   

  1. 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
  • 收稿日期:2016-12-05 修回日期:2016-12-05 出版日期:2016-11-20 发布日期:2016-12-05
  • 作者简介: 杨雪,女,在读硕士,临床中药学。

Literature Analysis of 193 Cases of Adverse Reactions of Xanthii Fructus

YANG Xue1, XIA Dong-sheng2, *, GAO Jian-chao2, TIAN Chun-hua2, LI Lan2, ZHANG Bing1   

  1. 1.Beijing University of Chinese Medicine, Beijing 100029, China;
    2.Center for Drug Reevaluation, CFDA, Beijing 100045, China.
  • Received:2016-12-05 Revised:2016-12-05 Online:2016-11-20 Published:2016-12-05
  • Contact: 夏东胜,女,主任药师,药品不良反应监测与评价。E-mail:xiadongsheng@cdr-adr.org.cn
  • Supported by:
    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。

关键词: 苍耳子, 不良反应, 文献分析

Abstract: Objective To explore the clinical toxicity characteristics and risk factor, in order to offer literature basis for clinical safety medication. Methods The adverse reactions of Xanthii Fructus on literatures between January 1st, 1953 April 1st, 2016 were summarized, the toxicity characteristics and risk factors for clinical use were analyzed. Results Oral and external use of Xanthii Fructus can lead to adverse reactions. Oral use of Xanthii Fructus caused multiple organ damage, the main damages are digestive 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 Xanthii Fructus should be paid attention in the clinical use, so as to control the risk factors and prevent the happening of adverse drug reactions.

Key words: Xanthii Fructus, adverse reaction, literature analysis

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