中国中药杂志

2015, v.40(10) 2037-2041

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315例天麻素临床不良反应/事件分析
Analysis on 315 cases of clinical adverse drug reaction / event induced by gastrodin

郑洋洋;董志;路晓钦;夏永鹏;朱舒兵;
ZHENG Yang-yang;DONG Zhi;LU Xiao-qin;XIA Yong-peng;ZHU Shu-bing;School of Pharmacy,Chongqing Medical University;Chongqing Ninth People's Hospital;Chongqing Food and Drug Administration;Chongqing Adverse Drug Reaction Monitoring Center;

摘要(Abstract):

以患者一般情况、用药情况、不良反应/事件(ADR/ADE)发生时间、临床表现及转归等作为考查项,对重庆市2008年1月—2014年6月天麻素所致的315例ADR/ADE进行回顾性研究,以分析其ADR/ADE发生的特点,为临床合理用药提供参考。结果发现在315例发生ADR/ADE的患者中,男性143例(45.4%),女性172例(54.6%),主要发生于45岁以上年龄段患者(74.9%);60例ADE(19.0%)为超适应证用药引起,66例ADE(21.0%)为超剂量用药引起;静脉滴注致ADR/ADE多发生于30 min内(85.5%),口服给药致ADR/ADE多发生于口服后2 h内(74.4%),肌内注射致ADR/ADE均发生于10min内。共发生ADR/ADE 593例次,以胃肠系统(30.9%)、皮肤及其附件(26.5%)损害为主,61.9%为新的ADR/ADE。提示医务人员应了解天麻素所致ADR/ADE的规律和特点,临床上规范化应用,并密切关注患者变化,重视ADR/ADE的监测工作,提高用药安全性。
With patients' general situation,medication use,occurrence time of adverse drug reaction/event( ADR/ADE),clinical manifestations and prognosis as reference items,a retrospective study was made for 315 cases with ADR / ADE induced by Gastrodin in Chongqing from January 2008 to June 2014,in order to analyze the characteristics of ADR / ADE and provide reference for rational clinical medication. The results showed that among the 315 cases with ADR / ADE,143 cases( 45. 4%) were males and 172 cases( 54. 6%) were females,most of them( 74. 9%) were aged above 45; 60 cases( 19. 0%) with ADE were caused by off-label indications and 66 cases( 21. 0%) with ADE were caused by over dosage; ADR / ADE cases induced by intravenous drip mainly happened within 30 min( 85. 5%),ADR / ADE cases induced by oral administration mainly happened within 2 h( 74. 4%),and all of ADR /ADE cases induced by intramuscular injection happened within 10 min. Totally 593 ADR / ADE cases were reported,which were mainly damages in gastrointestinal system,skin and its adnexa; And 61. 9% of ADR / ADE cases were newly reported. It is suggested that medical workers shall learn about the regularity and characteristics of ADR / ADE induced by gastrodin,apply it in clinic with standards,pay close attention to changes of patients' situations and attach importance to the monitoring of ADR / ADE,so as to enhance the safety of medication.

关键词(KeyWords): 天麻素;不良反应/事件;分析
gastrodin;adverse drug reaction/event;analysis

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基金项目(Foundation): 重庆市卫生局科技计划重点项目(2013-1-052)

作者(Author): 郑洋洋;董志;路晓钦;夏永鹏;朱舒兵;
ZHENG Yang-yang;DONG Zhi;LU Xiao-qin;XIA Yong-peng;ZHU Shu-bing;School of Pharmacy,Chongqing Medical University;Chongqing Ninth People's Hospital;Chongqing Food and Drug Administration;Chongqing Adverse Drug Reaction Monitoring Center;

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