今日药学

2015, v.25(09) 649-652

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166例中药制剂不良反应报告分析
Analysis of 166 ADR Reports Associated with Herbal Preparations

潘莹;刘韬;魏雪;梁蔚婷;李晓燕;陈卓佳;黄红兵;
PAN Ying;LIU Tao;WEI Xue;LIANG Weiting;LI Xiaoyan;CHEN Zhuojia;HUANG Hongbing;State Key Laboratory of Oncology in South China,Collaborative Innovation Center of Cancer Medicine,Sun Yat-sen University Cancer Center;

摘要(Abstract):

目的探讨中药制剂药品不良反(ADR)应发生的原因和特点,为临床合理用药提供参考。方法采用回顾性研究方法,对本院2005-01~2014-12收集的中药制剂不良反应报告从患者、不良反应信息、涉及药品及合理用药4个方面进行统计分析。结果 166例报告中中年患者所占比例较高;82.5%ADR发生在用药开始2 h以内,可累及全身各个系统,新发案例占66.9%;所涉中药制剂98.2%为注射剂型,复方制剂ADR发生比例高于单方;48.2%的ADR涉及不合理用药,其中最常见的不合理使用情况为超剂量用药(30.7%)。结论中药制剂的ADR发生与多种因素有关,应重视中药制剂的不良反应,提高合理用药水平。
OBJECTIVE To investigate the characteristic of ADR caused by herbal preparations,and provide data for rational drug application in clinical practice. METHODS A total of 166 ADRs associated with herbs were collected in Sun Yat-sen University Cancer Center( SYSUCC) from January 2005 to December 2014,and the patient and drug characteristics,ADR information and medical orders of the cases were analyzed by retrospective study method. RESULTS The proportion of middle-aged patients was the prominent of 166 cases. And 82. 5% ADRs occurred at the beginning of medication within 2 hours. New-onset cases accounted for66. 9%,and every system all over the body can be involved. Injection formulation accounts for 98. 2%,and the incidence of ADR of multi-formula was higher. Inappropriate prescribing was involved in 48. 2% cases,and the drug overdose( 30. 7%) was the most common one. CONCLUSION ADR of herbal preparations is correlated with multiple factors,and attention should be paid to promote rational use of Chinese herbs.

关键词(KeyWords): 药品不良反应;中药制剂;不良反应监测
adverse drug reaction;herbal preparations;ADR monitoring

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基金项目(Foundation): 广东省药学会肝炎用药研究基金(2012G28);; 广东省自然科学基金(10451008901004256)

作者(Author): 潘莹;刘韬;魏雪;梁蔚婷;李晓燕;陈卓佳;黄红兵;
PAN Ying;LIU Tao;WEI Xue;LIANG Weiting;LI Xiaoyan;CHEN Zhuojia;HUANG Hongbing;State Key Laboratory of Oncology in South China,Collaborative Innovation Center of Cancer Medicine,Sun Yat-sen University Cancer Center;

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