中国药物警戒 ›› 2013, Vol. 10 ›› Issue (6): 362-365.

• 药械安全性研究 • 上一篇    下一篇

养血生发胶囊相关肝损害风险分析

杨乐,郭晓昕,宋海波   

  1. 国家食品药品监督管理局药品评价中心,北京100045
  • 收稿日期:2013-01-04 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: 宋海波,男,副主任药师,临床药理,药品不良反应监测与评价。E-mail:songhaibo@cdr.gov.cn
  • 作者简介:杨乐,男,主管药师,药品不良反应监测与评价。

Hepatic Lesion Risk Analysis of Yangxueshengfa Capsule

YANG Le ,GUO Xiao-xin ,SONG Hai-bo   

  1. Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2013-01-04 Revised:2016-03-09 Online:2013-06-08 Published:2016-03-09

摘要: 通过对养血生发胶囊安全性相关的国内文献报道、上市后的安全性研究状况进行分析,评价养血生发胶囊上市后的安全性情况(肝损害)及风险特点,提出符合药品本身特点的风险控制措施,为安全、合理使用该药提供建议。

关键词: 养血生发胶囊, 风险分析, 措施

Abstract: By reviewing the relevant references and reports of the adverse drug reaction cases of Yangxueshengfa capsule in China, the post-marketing safety and risks(hepatic lesion) in post-marketing period of Yangxueshengfa capsule were reevaluated in this article. Risk management measures according to the characteristics of medicine were put forward. Suggestions were proposed for a safe and rational use of this medicine.

Key words: Yangxueshengfa capsule, safety and risk analysis, measure

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