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丹参注射剂561例临床不良反应/事件分析
Analysis on 561 Cases of Clinical Adverse Drug Reaction/event Caused by Danshen Injection
  
DOI:
中文关键词:  丹参注射剂  中药注射剂  药品不良反应/事件  安全用药
英文关键词:Danshen injection  Traditional Chinese medicine injections  Adverse drug reactions/events  Safety use of drug
基金项目:
作者单位
桂玲 刘金玉 张程亮 刘东 ①华中科技大学同济医学院附属同济医院药学部(武汉430030) 
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中文摘要:
      摘 要 目的:分析丹参注射剂所致不良反应发生的特点,为临床安全用药提供参考。方法:采用回顾性研究方法,对2012~2014年湖北省药品不良反应监测中心收集的561例丹参注射剂所致不良反应/事件(ADR/ADE),以患者性别、年龄、过敏史,ADR/ADE发生时间、临床表现及转归等指标作为考查项,进行统计分析。结果:561例ADR/ADE患者男女比例为1∶1.109,主要发生人群为40岁以上的患者(85.93%)。共发生ADR/ADE 784例次,主要发生时间为给药后30 min以内(56.86%),主要临床表现为皮肤及其附件损害(34.31%)、全身性损害(16.45%)、心率及心律紊乱(12.76%),其中严重不良反应构成比为4.5%。结论:丹参注射液可引起不同程度的不良反应,临床用药时应给予足够重视,需加强ADR/ADE监测,提高用药安全性。
英文摘要:
      ABSTRACT Objective:According to analyzing the characteristics of the ADR/ADE caused by Danshen injection, provide reference information for clinical rational drug use. Methods:By a retrospective study, 561 cases with ADR/ADE induced by Danshen njection in Hubei province from January 2012 to December 2014, was analyzed with patient’s gender, age, occurrence time of adverse drug reaction/event (ADR/ADE), allergic history, clinical manifestations and prognosis.Results:Among the 561 cases with ADR/ADE, the male/female ratio was 1∶1.109, most of them (85.93%) were aged above 40 and the occurrence time of ADR/ADE cases mainly happened within 30 min after the treatment(56.86%). Totally 561 ADR/ADE cases were reported that mainly damaged in skin and its adnexa(34.31%), systemic lesion(16.45%), heart rate and rhythm disorders(12.76%), etc. And the incidence of serious adverse reaction was 4.5%. Conclusion:Different degrees of ADR/ADE can be induced by Danshen njection, while enough attention should be paid to the clinical use of the injections. And ADR/ADE monitoring also should be strengthened to improve the safety of medication.
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