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56例丹参川芎嗪注射液不良反应/事件分析

李蓓   

  1. 哈尔滨市药品不良反应监测中心
  • 收稿日期:2013-05-01 修回日期:2013-05-01 出版日期:2013-06-25 发布日期:2013-06-24

Analysis of 50 Cases of Adverse Drug Reactions Due to Salvia Miltiorrhiza and Ligustrazine Hydrochloride Injection

  1. Harbin Center for ADR Monitoring
  • Received:2013-05-01 Revised:2013-05-01 Online:2013-06-25 Published:2013-06-24

摘要: 目的:分析丹参川芎嗪注射液不良反应/事件(ADR/ADE)发生的一般规律,为临床合理用药提供参考。方法:对2011年1月至2012年12月间有关丹参川芎嗪注射液的56例ADR/ADE报告从患者一般情况、不良反应发生时间、ADR/ADE累及的系统-器官及临床表现等方面进行回顾分析。结果:56例ADR/ADE病例报告中,以60岁以上老年人居多,占67.86%。在静脉滴注过程中发生ADR/ADE的占总例数的46.43%。临床表现以皮肤及其附件损害为主的占36.36%。既往药物过敏史不详的占67.86%。家族药物过敏史不详的占69.64%。结论:丹参川芎嗪注射液ADR/ADE的发生与多种因素有关,临床用药应加强监测,以防范ADR/ADE的发生。

Abstract: Objective: To analyze the characteristics of adverse drug reaction/event (ADR/ADE) induced by salvia miltiorrhiza and ligustrazine hydrochloride injection so as to promote clinical proper medicating. Methods: 56 ADR/ADE cases caused by salvia miltiorrhiza and ligustrazine hydrochloride injection reported from January 2011 to December 2012 were retrospectively analyzed from patients with general conditions, adverse reaction time, clinical manifestations and other aspects. Results: In 56 cases of ADR/ADE, most of the patients were 60 years of age or older, it was accounted for 67.86%. ADR/ADE appearing within intravenous drip accounted for 46.43% of the total number of cases. Skin and its appendages damage was the major clinical manifestations, accounting for 36.36%. Unknowing personal atopic history accounted for 67.86%,unknowing family atopic history accounted for 69.64% of the total number of cases.Conclusion: The ADR/ADEs of salvia miltiorrhiza and ligustrazine hydrochloride injection are associated with many factors. Clinical application should be monitored closely, in order to prevent the occurrence of ADR/ADE.