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 1董志 1路晓钦 2夏永鹏 3朱舒兵4
作者信息
- 1. 重庆医科大学药学院,重庆400016
- 2. 重庆市第九人民医院,重庆400700
- 3. 重庆市食品药品监督管理局,重庆400042
- 4. 重庆市药品不良反应监测中心,重庆400014
- 折叠
摘要
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2h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.
Abstract
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
天麻素/不良反应/事件/分析Key words
gastrodin/adverse drug reaction/event/analysis引用本文复制引用
基金项目
重庆市卫生局科技计划重点项目(2013-1-052)
出版年
2015
国家科技期刊平台
NSTL
维普
万方数据