中国药物警戒 ›› 2013, Vol. 10 ›› Issue (6): 321-323.

• 基础及临床研究 •    下一篇

银杏内酯注射液不良反应鉴定的试验研究

柳于介12, 萧伟1*,王振中1,赵宾江1,田恒勇1,黄宇虹3, 郭家奎3,翁维良4   

  1. 1.江苏康缘药业股份有限公司,江苏连云港222001；
    2.南京中医药大学,江苏南京210046；
    3.天津中医药大学第二附属医院,天津300150；
    4.中国中医科学院西苑医院,北京100091
  • 收稿日期:2012-12-06 修回日期:2016-03-09 出版日期:2013-06-08 发布日期:2016-03-09
  • 通讯作者: 萧伟,男,博士,研究员,中药新剂型的研究与开发。E-mail:wzh-nj@163.net
  • 作者简介:柳于介,男,在读硕士,高级工程师,药物临床研究和再评价。
  • 基金资助:
    国家科技部重大新药创制“中药治疗心脑血管疾病有效成首先接受皮肤过敏原测试,如患者为非过敏体质,对试分组（群）的创新药物孵化基地”项目（编号：2011ZX09401-097）。

The Identified Study on Adverse Reactions of Ginkgolide Injection

LIU Yu-jie1,2 ,XIAO Wei1* ,WANG Zhen-zhong1 ,ZHAO Bin-jiang1 ,TIAN Heng-yong1 ,HUANG Yu-hong3 ,GUO Jia-kui3 ,WENG Wei-liang4   

  1. 1.Jiangsu Kanion Pharmaceutical Co.,Ltd, Jiangsu Lianyungang 222001, China;
    2.Nanjing University of Traditional Chinese Medicine, Jiangsu Nanjing 210046, China;
    3.Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China;
    4.Xiyuan Hospital of China Academy of Traditional Chinese Sciences, Beijing 100091, China
  • Received:2012-12-06 Revised:2016-03-09 Online:2013-06-08 Published:2016-03-09

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摘要： 目的 探索1例对银杏内酯注射液过敏受试者发生的不良事件是否为试验药物引起的过敏反应,并进一步明确该不良事件与试验药物之间的相关性。方法 在充分有效的风险防范措施下,根据激发试验原理,采用变应原皮肤点刺、皮内注射过敏试验等方法,开展受试者不良事件与药物相关性的探索性试验研究。结果 受试者免疫系统功能正常,为非过敏体质者,对银杏内酯注射液不引起过敏反应。结论 表明点刺过敏原试验联合皮肤过敏试验是对中药注射剂过敏反应监测的有益尝试,可能会成为预警高致敏中药注射剂过敏反应和药物临床不良反应相关性分析判断的方法之一。

关键词: 银杏二萜内酯, 过敏反应, 变应原, 皮肤过敏试验, 激发试验

Abstract: Objective To explore whether the adverse events of one subject who was allergic to ginkgolide injection was related to the drug allergy and to clarify the correlation with drug. Methods Under the adequate and effective risk prevention, an exploratory was carried out to find the relation between adverse events and drug using allergen skin prick test methods. Results Research showed the participant had a normal immune system function and no allergic diathesis, there was no allergic reactions on ginkgolide. Conclusion It is an useful attempt to monitor allergic reactions of traditional Chinese medicine injection by prick allergen test and skin allergy test. It will become one of the Methods which warn the relationships between highly sensitized traditional Chinese medicine injection and clinical adverse reactions of drugs.

Key words: diterpene lactones of ginkgo, allergic reaction, allergen, skin allergy test, provocation test

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