中国药物警戒 ›› 2017, Vol. 14 ›› Issue (10): 615-621.

• 安全性评价与合理用药 • 上一篇    下一篇

508例附子不良反应文献分析

杨雪1,2, 夏东胜3*, 田春华3, 李岚3, 孙毅4   

  1. 1.西北高原生物研究所,青海西宁810000;
    2.中国科学院大学,北京100049;
    3.国家食品药品监督管理总局药品评价中心,北京100045;
    4.云南省玉溪市药品不良反应与药物滥用监测中心,云南玉溪653100
  • 收稿日期:2017-11-30 修回日期:2017-11-30 出版日期:2017-10-20 发布日期:2017-11-30
  • 通讯作者: 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
  • 作者简介:杨雪,女,在读硕士,天然药物化学和药物警戒。
  • 基金资助:
    基金资助:中医药行业科研专项(201507004):临床常用中药配伍减毒作用研究。

Literature Analysis of 508 Cases Reports of Adverse Reactions Induced by Aconiti Lateralis Radix Praeparata

YANG Xue1,2, XIA Dong-sheng3*,TIAN Chun-hua3,LI Lan3,Sun Yi4   

  1. 1.Northwest Institute of Plateau Biology, Chinese Academy of Science, Qinghai Xining 810001, China;
    2.University of the Chinese Academy of Sciences, Beijing 100049, China;
    3.Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China;
    4.Center for Yuxi Drug Adverse Reaction and Drug Abuse Monitoring, Yunnan Yuxi 653100, China
  • Received:2017-11-30 Revised:2017-11-30 Online:2017-10-20 Published:2017-11-30

摘要: 目的 探讨附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月至2017年5月附子不良反应相关文献,在建立数据库并进行分项统计与分析的基础上,提取附子毒性特点及安全性影响因素。结果 附子口服和外用均可致不良反应。口服附子所致不良反应可累及多个系统-器官,以神经系统损害、消化系统损害和心血管系统损害为主,此外也包括呼吸系统损害、泌尿系统损害、视觉损害、全身性损害和皮肤及其附件损害等;外用可致皮肤及其附件损害。附子不良反应的主要风险因素有:生品用药、超剂量用药、煎煮不当、偏方/药膳使用、误服等。结论 应重视附子毒性,控制其风险因素,严防误用并有效防止不良反应的发生。

关键词: 附子, 不良反应, 文献分析

Abstract: Objective To explore the clinical toxicit characteristics and risk factors of Aconiti Lateralis Radix Praeparata, in order to offer literature basis for clinical safety medication. Methods The adverse reactions of Aconiti Lateralis Radix Praeparata on literatures between January 1st, 1953 to May 1st, 2017 were summarized, and analyzed the toxicity characteristics and risk factors for clinical use. Results Both oral and external use of Aconiti Lateralis Radix Praeparata can lead to the adverse reactions. Oral use of Aconiti Lateralis Radix Praeparata causes multiple organ damage, the main injuries are nervous system injury, digestive system injury and cardiovascular system injury. And other damages are respiratory system injury, urinary system injury, visual impairment, systemic lesions and skin and its accessories damage. External use can cause skin and its accessories damage. The main risk factors of adverse reactions of Radix Aconite Lateral are raw product use, drug overdosage, improper decoction, using of folk prescription/medicined diet and drug misusage. Conclusion Toxicity of Aconiti Lateralis Radix Praeparata should be paid attention to in the clinical use, control the risk factors and prevent the happening of the adverse drug reaction.

Key words: aconiti lateralis radix praeparata , adverse reactions, literature analysis

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